HES data for IQVIA clinical trial site identification
IQVIA Technology Services Ltd. · Supplier
In term In term in the September 2026 edition: the latest version runs to 7 November 2027.
- Reference
- DARS-NIC-210151-K9C7G
- Current version
- v6.2
- Term of current version
- 8 November 2024 to 7 November 2027
- Start date
- Before 6 December 2019
- Data controller
- Sole Data Controller
- Commercial purposes
- Yes
- Sublicensing
- No
- Files released to date
- 0
Data controllers
Why the data was released
Objective for processing
IQVIA Ltd is a commercial company which generates profit from providing services and solutions, including analysis, interpretation and reports, to its customers. Those analyses, interpretations and reports assist such customers in supporting the understanding of care pathways, delivering clarity to hospitals on their use of medicines, enabling the development of diagnostic algorithms, enabling patients to be recruited to trials, and supporting healthcare commissioners and providers in achieving exceptional Data quality. These services can enable the development of health economic models that evaluate care delivery in relation to outcomes achieved for the patient and in so doing, help advance and benefit healthcare in a variety of different ways.
The services to which this Data Sharing Agreement (DSA) relates are to be provided by IQVIA Ltd. and any companies that are part of the same group of companies as those entities anywhere in the world (an “Affiliate”). For the avoidance of doubt, the only access Affiliates will have to the data provided hereunder will be to aggregated and small-number suppressed data.
Affiliates are not clients. Affiliates are companies that are part of the same group of companies as IQVIA Ltd. Clients are companies external to IQVIA Ltd. and/or their Affiliates.
The territory of use for the data under this Agreement is restricted to England and Wales.
IQVIA Ltd is the sole controller who process the data for the purposes described within this DSA.
The Legal basis for processing of personal data relating to patient health is under Article 9(2)(j)of the GDPR - Processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. The data subjects’ interests and fundamental rights are protected through appropriate minimisation of fields; protection of the data in a secure environment and guaranteeing secure destruction at any stage at the request of NHS Digital or after a defined period on completion of the project.
IQVIA are processing the data according to their legitimate interests. This is covered under the GDPR Article 6(1)(f) - This work is necessary for the purposes of the legitimate interests pursued by the controller except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child. As set out in the legitimate interest assessment - the data requested is to help achieve the following:
Care Pathway Analysis,
Hospital Feedback services,
Benchmarking,
Diagnostic algorithm development studies,
Epidemiology studies,
Health economics and outcomes research studies,
Trust data quality reviews,
Clinical trial analysis.
The services listed above are examples which provide benefits to the NHS. The provision of these services is contingent on the supply of HES data. Delivering these services is seen to be in the interest of the data subjects within HES. A full description of these benefits and their associated outcomes are provided under DARS-NIC-373563-N8Z9J In this DSA only benefits associated with Clinical Trial Site Identification (CTSI) analysis are described in full.
IQVIA Ltd. already have a DSA for pseudonymised record-level HES data (DARS-NIC-373563-N8Z9J) (the “Existing DSA”) pursuant to which IQVIA Ltd. are permitted to use HES data via one or more appropriate software applications. The software application is used to display HES data, with data aggregated and small number suppressed in line with the HES analysis guide and is controlled and auditable. Users are given role-based access to these applications, which allow users to perform analyses on aggregated HES data and data from other sources and then view graphs and tables. The analyses may be stratified by diagnosis, organisation and other parameters. The purpose of this DSA which is independent of the Existing DSA (DARS-NIC-373563-N8Z9J), is a request for IQVIA Ltd. and their Affiliates to use any such appropriate software application (an “Appropriate Software Tool”), in order to provide a further permitted service, (bespoke aggregations with small numbers suppressed in line with the HES analysis guide based on the record-level data provided) as described below. This DSA permits the re-use of the pseudonymised HES APC, HES OP, HES A&E and ECDS data received under DARS-NIC-373563-N8Z9J for the purpose of supporting IQVIA run its CTSI service. In line with the GDPR Principle of Data Minimisation IQVIA Ltd have only requested fields that have been deemed necessary for the purpose of this work and the work outlined in DARS-NIC-373563-N8Z9J.
Clinical Trial Site Identification services
IQVIA Ltd. and their Affiliates will use the HES data via an Appropriate Software Tool to perform CTSI. Affiliates will only access the HES data where it is aggregated with small numbers suppressed in line with the HES analysis guide. CTSI consists of the production of lists of hospital sites with estimates of the size of the patient population at those sites, and lists of physicians affiliated with those sites (by cross-referencing site names and National Administrative Codes Service (NACS) codes against internal data sources of IQVIA Ltd. and their Affiliates); identification of the presence of referral networksʹ data on patients being transferred between sites; and visualisation of the above analyses, e.g. heat maps to show patient density. The purpose of these analyses is to determine whether clinical trials are feasible based on site and patient availability and to advise external clients of the above. There are no alternative, less intrusive ways of achieving the purpose. Examples of the clients of IQVIA Ltd. and their Affiliates are described below.
Note that, for the purpose of CTSI services, IQVIA Ltd. and their Affiliates will only use HES data that has been aggregated and small number suppressed through the use of an Appropriate Software Tool.
Clients of IQVIA Ltd. and their Affiliates
CTSI services will only be provided to the following types of organisations:
• Life sciences industry, such as
o Clinical research organisations (CROs)
o Pharmaceutical companies
o Medical device companies
• Providers of healthcare services, such as
o Clinical Commissioning Groups/Integrated Care Systems
o Commissioning Support Units (CSUs)
o Hospital Trusts
o Private secondary care providers
o Mental Health trusts
o Community Provider Trusts
o Pharmacies
o NHS England
• Universities
• Life sciences industry associations such as the Association of the British Pharmaceutical Industry (ABPI)
Examples of life sciences industry organisations include large pharmaceutical companies engaged in research and development of new medicines.
The specific organisations and the number of organisations to whom IQVIA Ltd. and their Affiliates provide products and services changes regularly as the global healthcare market is dynamic: the products, therapies and services required by healthcare providers change over time, as do the suppliers of these products, therapies and services.
Third parties to whom IQVIA Ltd. and their Affiliates shall provide CTSI analyses and results will only see aggregated and small number suppressed data. Data will not be provided in record level form to any third party. IQVIA Ltd. and their Affiliates understand the importance of data minimisation. IQVIA Ltd. and their Affiliates will not use outputs for commercial/marketing purposes.
IQVIA Ltd.’s requirements of HES Data
The following paragraphs outline IQVIA Ltd.’s and their Affiliates’ requirement for national, timely HES data covering several years for the purposes of CTSI.
• IQVIA Ltd. require national data to analyse estimated patient populations at all hospitals in England and Wales and compare these with similar estimates of patient populations in other countries in which IQVIA Ltd. and their Affiliates undertake CTSI (using data sources specific to those countries). This information helps clients of IQVIA Ltd. and their Affiliates to select suitable countries in which to recruit patients into clinical trials, in order to develop new medicines and treatments for patients.
• IQVIA Ltd. require timely data because the clients to whom IQVIA Ltd. and their Affiliates provide CTSI analyses and results need to make decisions based on the most up-to-date information. Clients of IQVIA Ltd. and their Affiliates are often interested in patient populations who have been treated with medicines or treatments that are new to the healthcare market and whose utilisation will only be measurable in the most up-to-date HES data. This information can help clients of IQVIA Ltd. and their Affiliates decide how best to develop cheaper competing medicines and treatments and bring them to market, which in turn can reduce the cost to healthcare providers and the NHS of providing patient care.
• IQVIA Ltd. require historic data to enable CTSI analyses to provide insight into changes in patient populations over time. Clients of IQVIA Ltd. and their Affiliates are often interested in how patient populations are treated in different ways as new medicines and treatments become available, making certain categories of patients more or less frequent over time. In addition, clinical trials are often conducted over long periods of time (often a number of years). Historic data provides more accurate estimates of the size of patient populations at hospitals over a multi-year period than extrapolations from more recent data covering a shorter period.
Processing activities
No data flows into NHS England as part of this Data Sharing Agreement (DSA). This DSA permits the re-use of an aggregated sub-set of data already held by the controller (IQVIA Ltd.) under DARS-NIC-373563-N8Z9J.
No data linkage will take place with the data being accessed under this DSA.
Please note that, for the purpose of CTSI services, IQVIA Ltd. and their Affiliates will only use HES data that has been aggregated with small numbers suppressed through the use of an Appropriate Software Tool, in line with the HES analysis guide.
Clients and end users will have access to aggregated data with small number suppressed and are compliant with the HES Analysis Guide.
Access to patient level data is not provided under this DSA.
IQVIA Ltd. will receive Hospital Episode Statistics data from NHS England and will apply derivations. No linkage is carried out to other datasets. In the context of this DSA applying derivations does not mean linking to other patient level information. In this DSA, applying derivations means that IQVIA Ltd. will use non-identifiable data to derive new information. For example, length of stay is approximated using the relationship between admission and discharge dates and the cost of an admission is approximated using the NHS payment by results tariff.
Affiliates will only have access to data that has been aggregated with small numbers suppressed in line with the HES analysis guide.
All data visualisation and benchmarking tools are hosted by IQVIA Ltd. All data seen by end users is aggregated; small numbers are suppressed and are compliant with the HES Analysis Guide. Usage of these tools is auditable and role-based access controls are applied.
Relevant Extracts of HES Data/Access via an Appropriate Software Tool
For CTSI, aggregated and small number suppressed HES data on patient admissions (selecting based on criteria including specific diagnoses of interest, OPCS4 procedure codes, age, gender, etc.) will be extracted from an Appropriate Software Tool (“Relevant Extracts”).
Relevant Extracts will not contain personal identifying information that could be used to identify individual patients.
Data analysis will then be performed on the Relevant Extracts using software such as Microsoft Excel and other data analysis platforms. This may include the upload of Relevant Extracts from HES data into an internal data repository which enables analysis to be performed on data using techniques and scripts coded in e.g. Python or SQL programming languages. Site names from the Relevant Extracts will be cross-referenced with physician data internally held by IQVIA Ltd. and their Affiliates to identify (from such internally held physician data) the physicians affiliated with each site (“CTSI Analysis”).
IQVIA Ltd. and their Affiliates would identify which hospitals that appear in HES results. Then, taking the NACS code for each hospital in HES and using a data asset called OneKey which is proprietary to IQVIA Ltd, relevant doctors can be identified. OneKey is a database of health care professionals such as physicians that includes information on a physician’s name, workplace (address, NACS code͙, speciality, and other information such as research interests. Physicians are aware of their personal data being held in OneKey and are able to opt out of inclusion as well as to exercise their other rights (Subject Access Requests.). The purpose of this work would be to understand whether certain hospitals have doctors working there that could act as potential investigators for clinical trials. The controller for OneKey data is IQVIA Ltd.
IQVIA Ltd. and their Affiliates will add value to the data beyond what is already provided by NHS England. The employees of IQVIA Ltd. and their Affiliates will apply the knowledge and skills they possess to better understand specific patient populations and which hospitals treat such populations. This knowledge includes, for example, judgement as to what diagnosis codes, procedures, age and gender filters should be applied for a particular patient population of interests in order to evaluate the suitability of such patients for clinical trials. IQVIA Ltd.’s and their Affiliates’ prior experience working with specific hospitals on clinical trials will also be incorporated - data alone provided by NHS England would not include this.
Relevant Extracts of HES data will be used by employees of IQVIA Ltd. for CTSI Analysis to identify hospitals with suitable patient populations for clinical trials including common (e.g. diabetes) and rare (e.g. cystic fibrosis) diseases, and share the results of these analyses with its clients worldwide. For example, Relevant Extracts of HES data might be used to find out which hospitals in the UK have the most elderly patients with diabetes. This information could then help IQVIA Ltd., and their Affiliates or clients of IQVIA Ltd. and their Affiliates to identify which hospitals to contact in order to discuss running clinical trials testing a new diabetes medication, which might eventually help to make new treatments for diabetes available in the NHS.
In order to provide the CTSI Services and obtain the Relevant Extracts, employees of IQVIA Ltd. and their Affiliates may be granted access by IQVIA Ltd. to an Appropriate Software Tool for the purpose of obtaining Relevant Extracts in order for such Affiliate to conduct CTSI Analysis and make the resulting outputs available directly to its clients worldwide for the purposes set out herein, notwithstanding that any such Affiliate is not a named Data Recipient/licensee hereunder. For the avoidance of doubt, only employees of IQVIA Ltd. are permitted to access the non-identified record-level data, however aggregated data with small numbers suppression (in line with the HES Analysis Guide as per the data output generated by an Appropriate Software Tool) may be accessed worldwide.
Additionally, it is agreed that the services to be provided by IQVIA Ltd. and their Affiliates in relation to the CTSI Services, and the permitted uses of such relevant data by such third parties, do not constitute Distribution or require a Sub-Licence.
Communicating Findings to International Clients
Many clients of IQVIA Ltd. and their Affiliates are pharmaceutical companies developing and manufacturing treatments for diseases. These companies are located all over the world and they need to compare information about patient numbers from many countries to enable them to decide the best locations to run a trial. IQVIA Ltd. believe this provides a health benefit to the UK because these outputs help to support the decisions that drug companies make in choosing to run trials in the UK; this can result in faster evaluation and approval and therefore faster access to medicines by patients in the UK.
IQVIA Ltd. are themselves part of a multinational group of companies providing the same or similar services worldwide. In order for the UK to attract pharmaceutical companies to come to the UK and run clinical trials, IQVIA Ltd., and their Affiliates need to be able to critically assess the feasibility of running clinical trials in the UK versus other countries, and in order to do so their employees, wherever they are based, need to access and manipulate HES data using an Appropriate Software Tool and the other data analysis tools available to IQVIA Ltd., and their Affiliates as described in the section on Relevant Extracts. IQVIA Ltd. and their Affiliates will then be able to provide their findings to the relevant pharmaceutical companies, wherever they are based.
Employees of IQVIA Ltd. and their Affiliates with the skills required to perform CTSI Analysis are located in many countries throughout the world and, therefore, access to relevant extracts of HES data obtained by querying an Appropriate Software Tool is required by these employees wherever they are based. This will support timely analysis which helps to achieve the expected benefits of CTSI, i.e. accelerating study start-up. The staff of IQVIA Ltd. and their Affiliates are also permitted to work remotely including at home on the data only provided the device used to access the data (laptops) is a standard build with hard drive encryption.
Note that, in carrying out CTSI Analysis, employees of IQVIA Ltd. and their Affiliates would only be given access to data which has been amalgamated (known as aggregated and small numbers suppressed by NHS England) via an Appropriate Software Tool, as described previously. The software tool makes it possible to control access to HES data via permission settings for user accounts. User accounts in an Appropriate Software Tool would be set up (for the purpose of performing CTSI analysis based on Relevant Extracts of HES data) to only allow users (who would be employees of IQVIA Ltd. or its Affiliates) to perform the following processing activities:
• Define and run queries on HES data
• View results of queries (all results would be aggregated and small number suppressed in line with the HES Analysis Guide )
• Export results of queries, i.e. produce Relevant Extracts of HES Data
In addition to the rights of IQVIA Ltd. hereunder to use the data for the purposes of CTSI Analysis and to make the CTSI Outputs available to their clients worldwide, it is hereby agreed that any Affiliate of IQVIA Ltd. anywhere in the world may be granted access by IQVIA Ltd. to an Appropriate Software Tool for the purpose of obtaining Relevant Extracts in order for such Affiliate to conduct CTSI Analysis and make the resulting CTSI Outputs available directly to its clients worldwide for the purposes set out herein, notwithstanding that any such Affiliate is not a named Data Recipient/licensee hereunder. Only employees of IQVIA Ltd are permitted to access the non-identified record-level data (i.e. other than data that has been aggregated, with small numbers suppressed in line with the HES Analysis Guide).
Under no circumstances will IQVIA Ltd. or their Affiliates be sharing the direct output of the analyses (i.e. the results of queries or the Relevant Extracts of query results) with their clients. Clients of IQVIA Ltd. and their Affiliates will not have access to any Appropriate Software Tool for the purpose of CTSI. Clients of IQVIA Ltd. and their Affiliates will, should they request to see results of a particular CTSI analysis from IQVIA Ltd. or their Affiliates, receive a limited view of CTSI results consisting of a list of the sites (up to approximately 30 sites) estimated to have the largest patient populations for a given analysis, ranked by estimated numbers of patients per site.
Expected output
As stated under “Processing Activities", Relevant Extracts from an Appropriate Software Tool will be used for CTSI, the outputs of which shall consist of a list of hospital sites with estimates of the size of the patient population at those sites, a list of physicians affiliated with those sites (based on physician data internally held by IQVIA Ltd.), and visualisations of the CTSI Analysis; all of these outputs together shall comprise the “CTSI Outputs". The CTSI Outputs shall be produced to meet the previously stated purpose. Outputs will only contain aggregate level data with small numbers suppressed in line with the HES analysis guide, or estimates of patient numbers that are based on such aggregated and small number suppressed data.
CTSI Outputs shall occasionally be reported in journal articles or conference presentations. Examples of relevant industry conferences where CTSI Outputs may be reported include the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Drug Information Association (DIA) conferences.
Expected measurable benefits
CTSI projects and CTSI Outputs based on HES data are expected to generate benefits to UK healthcare by:
• accelerating study start-up through faster site identification and patient recruitment into clinical trials, which in turn will assist in improving patient access to treatments under development, especially for diseases that are rare and/or difficult to treat. IQVIA Ltd. and their Affiliates work across all major disease areas including cardiovascular diseases, oncology, paediatric indications, and many other less common indications.
• reducing the proportion of unsuccessful clinical trials, which could facilitate the approval and availability of potentially life changing medicines to patients in the UK
• reducing the cost of clinical trials, which could translate into reduced costs to manufacturers in developing new medicines and reduced costs to the NHS in procuring new medicines
• promoting the UK and the NHS as suitable for conducting clinical trials, which supports the evaluation and approval by UK and European Union-based regulatory bodies of medicines and treatments under development
The benefits above relate to the CTSI analysis alone, additional benefits are realised under DARS-NIC-373563-N8Z9J including changes in patient care, reduction in costs, uptake and monitoring of policy.
Benefits reported so far
Clinical trials are often multi-year projects for which results are only available at the end of the research study. As such, it is too early to gauge the full impact of HES data on the trials that have been supported last 1 years (i.e. since September 2023). This issue is compounded by many initial steps that are required even before running a trial, such as planning, protocol reviews, site selection, start-up and enrolment.
However, as of September 2024, IQVIA Ltd. and its Affiliates have been supporting 16 ongoing trials, including 4 Oncology, 3 respiratory, and 2 rare disease studies that referenced HES data. (12 Enrolling/4 Closed to enrolment) – 118 sites are Initiated while 230 patients have been enrolled.
Of these 16 studies, 6 have achieved greater than 50% enrolment. Reporting below observation for these 6 studies:
• 10% average improvement for recruitment rate vs the historical comparator (N=6)
• 14% average reduction in screen failure rate vs the historical comparator (N=6)
• 20% average improvement for recruitment rate vs initial strategy (N=5)
It is important to note that these are not the final proof points as the recruitment of 4 of these studies is still ongoing.
Without access to this HES data, it would not have been possible to enrol these patients into clinical trials. This has also enabled patients to receive cutting-edge therapies far sooner than would ordinarily be possible.
Datasets on the current version
Legal basis for provision: Health and Social Care Act 2012 – s261(2)(a)
| Dataset | Type of data | Sensitivity | Frequency | Confidential data |
|---|---|---|---|---|
| Emergency Care Data Set (ECDS) | Anonymised - ICO Code Compliant | Non-Sensitive | Ongoing | Does not include the flow of confidential data |
| Hospital Episode Statistics Accident and Emergency (HES A and E) | Anonymised - ICO Code Compliant | Non-Sensitive | Ongoing | Does not include the flow of confidential data |
| Hospital Episode Statistics Admitted Patient Care (HES APC) | Anonymised - ICO Code Compliant | Non-Sensitive | Ongoing | Does not include the flow of confidential data |
| Hospital Episode Statistics Outpatients (HES OP) | Anonymised - ICO Code Compliant | Non-Sensitive | Ongoing | Does not include the flow of confidential data |
Files released
Files released counts only files released externally by DARS. Access granted in NHS England's own systems, such as its Secure Data Environment, is not included.
No files recorded as released under this agreement.
Version history
The register lists each renewal of this agreement as a separate row. This site has 6 versions — earlier versions existed before this site's records begin.
DARS-NIC-210151-K9C7G-v6.2 8 November 2024 to 7 November 2027
- Title
- HES data for IQVIA clinical trial site identification
- Commercial
- Yes
- Sublicensing
- No
- Datasets
- 4
- Files released
- 0
Datasets: Emergency Care Data Set (ECDS); Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Outpatients (HES OP)
What changed from DARS-NIC-210151-K9C7G-v5.2
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2024-11-08 | |
| End date | 2027-11-07 |
Benefits reported
Clinical trials are often multi-year projects for which results are only available
[16 words unchanged]
full impact of HES data on the trials that have been supported
last 1 years (i.e.
since
October 2021.
September 2023).
This issue is compounded by many initial steps that are required even before running a trial, such as planning, protocol reviews, site selection, start-up and enrolment.
However, as of September
2022,
2024,
IQVIA Ltd. and its Affiliates
were
have been
supporting
28
16
ongoing trials, including
8 hematology, 6 oncology
4 Oncology, 3 respiratory,
and
6
2
rare disease
studies,
studies
that referenced HES data.
(4
(12 Enrolling/4
Closed to
enrolment/24 Enrolling)
enrolment)
–
91
118
sites are Initiated while
178
230
patients have been enrolled.
Of these
28
16
studies,
9
6
have achieved greater than 50% enrolment.
Reporting below observation for these 6 studies:
Based on the 3 projects (robust non-COVID trials) closed to enrolment between Oct 2021-Sep 2022, IQVIA Ltd. have observed:
• 10% average improvement for recruitment rate vs the historical comparator (N=6)
•
90%
14%
average
improvement for recruitment
reduction in screen failure
rate vs the
historic
historical
comparator
(N=3)
(N=6)
• 10% reduction of non-enrollers vs the historic comparator (N=3)
• 20% average improvement for recruitment rate vs initial strategy (N=5)
• 42% reduction of recruitment duration vs the historic comparator (N=3)
It is important to note that these are not the final proof points as the recruitment of 4 of these studies is still ongoing.
• 28% average improvement for recruitment rate vs initial strategy (N=3)
• 36% average reduction in screen failure rate vs initial strategy (N=3)
[1 paragraph unchanged]
Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits.
DARS-NIC-210151-K9C7G-v5.2 10 January 2024 to 22 October 2024
- Title
- HES data for IQVIA clinical trial site identification
- Commercial
- Yes
- Sublicensing
- No
- Datasets
- 4
- Files released
- 0
Datasets: Emergency Care Data Set (ECDS); Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Outpatients (HES OP)
What changed from DARS-NIC-210151-K9C7G-v4.3
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Data controller basis | Sole Data Controller | |
| Start date | 2024-01-10 | |
| End date | 2024-10-22 | |
| Emergency Care Data Set (ECDS): legal basis | Health and Social Care Act 2012 – s261(2)(a) | |
| Hospital Episode Statistics Accident and Emergency (HES A and E): legal basis | Health and Social Care Act 2012 – s261(2)(a) | |
| Hospital Episode Statistics Admitted Patient Care (HES APC): legal basis | Health and Social Care Act 2012 – s261(2)(a) | |
| Hospital Episode Statistics Outpatients (HES OP): legal basis | Health and Social Care Act 2012 – s261(2)(a) |
Data controllers:
− IQVIA TECHNOLOGY SERVICES LTD.
Objective for processing
IQVIA is a business comprised of a number of legal entities which provide technology and services to healthcare. IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates are commercial organisations who profit from providing services for the benefit of Health and Social Care. Please see section 5e for further information on the commercial nature of IQVIA and how it affects the use of data.
IQVIA Ltd is a commercial company which generates profit from providing services and solutions, including analysis, interpretation and reports, to its customers. Those analyses, interpretations and reports assist such customers in supporting the understanding of care pathways, delivering clarity to hospitals on their use of medicines, enabling the development of diagnostic algorithms, enabling patients to be recruited to trials, and supporting healthcare commissioners and providers in achieving exceptional Data quality. These services can enable the development of health economic models that evaluate care delivery in relation to outcomes achieved for the patient and in so doing, help advance and benefit healthcare in a variety of different ways.
The services to which this
agreement
Data Sharing Agreement (DSA)
relates are to be provided by IQVIA
Ltd., IQVIA Technology Services
Ltd. and any companies that are part of the same group of
[22 words unchanged]
the data provided hereunder will be to aggregated and small-number suppressed data.
Affiliates are not clients. Affiliates are companies that are part of the same group of companies as IQVIA Ltd.
and IQVIA Technology Services Ltd.
Clients are companies external to IQVIA
Ltd., IQVIA Technology Services
Ltd. and/or their Affiliates.
[1 paragraph unchanged]
IQVIA Ltd
and IQVIA Technology Services Ltd are joint data controllers
is the sole controller
who process the data for the purposes described within this
Data Sharing Agreement.
DSA.
[11 paragraphs unchanged]
IQVIA
Ltd. and IQVIA Technology Services
Ltd. already have a
Data Sharing Agreement (DSA)
DSA
for pseudonymised record-level HES data
(DARS-NIC-373563)
(DARS-NIC-373563-N8Z9J)
(the “Existing DSA”) pursuant to which IQVIA
Ltd. and IQVIA Technology Services
Ltd. are permitted to use HES data via one or more appropriate
[70 words unchanged]
The purpose of this DSA which is independent of the Existing DSA
(DARS-NIC-373563),
(DARS-NIC-373563-N8Z9J),
is a request for IQVIA
Ltd. and IQVIA Technology Services
Ltd. and their Affiliates to use any such appropriate software application (an
[22 words unchanged]
analysis guide based on the record-level data provided) as described below. This
Data Sharing Agreement
DSA
permits the re-use of the pseudonymised HES APC, HES OP, HES A&E
[15 words unchanged]
service. In line with the GDPR Principle of Data Minimisation IQVIA Ltd
and IQVIA Technology Services Ltd
have only requested fields that have been deemed necessary for the purpose of this work and the work outlined in DARS-NIC-373563-N8Z9J.
[1 paragraph unchanged]
IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates will use the HES data via an Appropriate Software Tool to perform
Clinical Trial Site Identification Services (CTSI). Affiliate s
CTSI. Affiliates
will only access the HES data where it is aggregated with small
[32 words unchanged]
lists of physicians affiliated with those sites (by cross-referencing site names and
site NACS
National Administrative Codes Service (NACS)
codes against internal data sources of IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates); identification of the presence of referral networksʹ data
[51 words unchanged]
intrusive ways of achieving the purpose. Examples of the clients of IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates are described below.
Note that, for the purpose of CTSI services, IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates will only use HES data that has been aggregated and small number suppressed through the use of an Appropriate Software Tool.
Clients of IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates
[17 paragraphs unchanged]
The specific organisations and the number of organisations to whom IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates provide products and services changes regularly as the
[15 words unchanged]
over time, as do the suppliers of these products, therapies and services.
Third parties to whom IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates shall provide CTSI analyses and results will only
[9 words unchanged]
not be provided in record level form to any third party. IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates understand the importance of data minimisation. IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates will not use outputs for commercial/marketing purposes.
IQVIA
Ltd.’s, and IQVIA Technology Services
Ltd.’s
Requirements
requirements
of HES Data
The following paragraphs outline IQVIA
Ltd.’s, IQVIA Technology Services
Ltd.’s and their Affiliates’ requirement for national, timely HES data covering several years for the purposes of CTSI.
• IQVIA
Ltd. and IQVIA Technology Services
Ltd. require national data to analyse estimated patient populations at all hospitals
[7 words unchanged]
with similar estimates of patient populations in other countries in which IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates undertake CTSI (using data sources specific to those countries). This information helps clients of IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates to select suitable countries in which to recruit patients into clinical trials, in order to develop new medicines and treatments for patients.
• IQVIA
Ltd. and IQVIA Technology Services
Ltd. require timely data because the clients to whom IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates provide CTSI analyses and results need to make decisions based on the most up-to-date information. Clients of IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates are often interested in patient populations who have
[21 words unchanged]
the most up-to-date HES data. This information can help clients of IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates decide how best to develop cheaper competing medicines
[12 words unchanged]
the cost to healthcare providers and the NHS of providing patient care.
• IQVIA
Ltd., and IQVIA Technology Services
Ltd. require historic data to enable CTSI analyses to provide insight into changes in patient populations over time. Clients of IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates are often interested in how patient populations are
[55 words unchanged]
multi-year period than extrapolations from more recent data covering a shorter period.
Processing activities
No data flows into NHS
Digital
England
as part of this
Agreement.
Data Sharing Agreement (DSA).
This
Agreement
DSA
permits the re-use of an aggregated sub-set of data already held by the
data controllers
controller (IQVIA Ltd.)
under DARS-NIC-373563-N8Z9J.
No data linkage will take place with the data being accessed under this
agreement.
DSA.
Please note that, for the purpose of CTSI services, IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates will only use HES data that has been
[8 words unchanged]
of an Appropriate Software Tool, in line with the HES analysis guide.
[2 paragraphs unchanged]
IQVIA
Ltd. and IQVIA Technology Services
Ltd. will receive Hospital Episode Statistics data from NHS
Digital
England
and will apply derivations. No linkage is carried out to other datasets. In the context of this
application/agreement
DSA
applying derivations does not mean linking to other patient level information. In this
application/agreement,
DSA,
applying derivations means that IQVIA
Ltd. and IQVIA Technology Services
Ltd. will use non-identifiable data to derive new information. For example, length
[15 words unchanged]
of an admission is approximated using the NHS payment by results tariff.
[1 paragraph unchanged]
All data visualisation and benchmarking tools are hosted by IQVIA
Ltd. and IQVIA Technology Services
Ltd. All data seen by end users is aggregated; small numbers are
[9 words unchanged]
Usage of these tools is auditable and role-based access controls are applied.
[3 paragraphs unchanged]
Data analysis will then be performed on the Relevant Extracts using software
[49 words unchanged]
Relevant Extracts will be cross-referenced with physician data internally held by IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates to identify (from such internally held physician data) the physicians affiliated with each site (“CTSI Analysis”).
IQVIA
Ltd., IQVIA Technology Services Ltd.,
Ltd.
and their Affiliates would identify which hospitals that appear in HES results.
[73 words unchanged]
opt out of inclusion as well as to exercise their other rights
(SARs, etc.).
(Subject Access Requests.).
The purpose of this work would be to understand whether certain hospitals have doctors working there that could act as potential investigators for clinical trials. The
data
controller for OneKey data is IQVIA Ltd.
IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates will add value to the data beyond what is already provided by NHS
Digital.
England.
The employees of IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates will apply the knowledge and skills they possess
[39 words unchanged]
order to evaluate the suitability of such patients for clinical trials. IQVIA
Ltd.’s, IQVIA Technology Services
Ltd.’s and their Affiliates’ prior experience working with specific hospitals on clinical trials will also be incorporated - data alone provided by NHS
Digital
England
would not include this.
Relevant Extracts of HES data will be used by employees of IQVIA
Ltd. and IQVIA Technology Services
Ltd. for CTSI Analysis to identify hospitals with suitable patient populations for
[43 words unchanged]
most elderly patients with diabetes. This information could then help IQVIA Ltd.,
IQVIA Technology Services Ltd.
and their Affiliates or clients of IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates to identify which hospitals to contact in order
[12 words unchanged]
eventually help to make new treatments for diabetes available in the NHS.
In order to provide the CTSI Services and obtain the Relevant Extracts, employees of IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates may be granted access by IQVIA
Ltd. and IQVIA Technology Services
Ltd. to an Appropriate Software Tool for the purpose of obtaining Relevant
[37 words unchanged]
Recipient/licensee hereunder. For the avoidance of doubt, only employees of IQVIA Ltd.
and IQVIA Technology Services Ltd.
are permitted to access the non-identified record-level data, however aggregated data with
[13 words unchanged]
data output generated by an Appropriate Software Tool) may be accessed worldwide.
Additionally, it is agreed that the services to be provided by IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates in relation to the CTSI Services, and the
[6 words unchanged]
by such third parties, do not constitute Distribution or require a Sub-Licence.
[1 paragraph unchanged]
Many clients of IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates are pharmaceutical companies developing and manufacturing treatments for
[22 words unchanged]
enable them to decide the best locations to run a trial. IQVIA
Ltd. and IQVIA Technology Services
Ltd. believe this provides a health benefit to the UK because these
[25 words unchanged]
approval and therefore faster access to medicines by patients in the UK.
IQVIA
Ltd. and IQVIA Technology Services
Ltd. are themselves part of a multinational group of companies providing the
[13 words unchanged]
companies to come to the UK and run clinical trials, IQVIA Ltd.,
IQVIA Technology Services Ltd.
and their Affiliates need to be able to critically assess the feasibility
[32 words unchanged]
Software Tool and the other data analysis tools available to IQVIA Ltd.,
IQVIA Technology Services Ltd.
and their Affiliates as described in the section on Relevant Extracts. IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates will then be able to provide their findings to the relevant pharmaceutical companies, wherever they are based.
Employees of IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates with the skills required to perform CTSI Analysis
[43 words unchanged]
expected benefits of CTSI, i.e. accelerating study start-up. The staff of IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates are also permitted to work remotely including at
[10 words unchanged]
access the data (laptops) is a standard build with hard drive encryption.
Note that, in carrying out CTSI Analysis, employees of IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates would only be given access to data which has been amalgamated (known as aggregated and small numbers suppressed by NHS
Digital)
England)
via an Appropriate Software Tool, as described previously. The software tool makes
[37 words unchanged]
HES data) to only allow users (who would be employees of IQVIA
Ltd., IQVIA Technology Services
Ltd. or its Affiliates) to perform the following processing activities:
[3 paragraphs unchanged]
In addition to the rights of IQVIA
Ltd. and IQVIA Technology Services
Ltd. hereunder to use the data for the purposes of CTSI Analysis
[9 words unchanged]
clients worldwide, it is hereby agreed that any Affiliate of IQVIA Ltd.
and IQVIA Technology Services Ltd.
anywhere in the world may be granted access by IQVIA
Ltd. and IQVIA Technology Services
Ltd. to an Appropriate Software Tool for the purpose of obtaining Relevant
[32 words unchanged]
Affiliate is not a named Data Recipient/licensee hereunder. Only employees of IQVIA
Ltd. and IQVIA Technology Services Ltd.
Ltd
are permitted to access the non-identified record-level data (i.e. other than data that has been aggregated, with small numbers suppressed in line with the HES Analysis Guide).
Under no circumstances will IQVIA
Ltd., IQVIA Technology Services
Ltd. or their Affiliates be sharing the direct output of the analyses
[6 words unchanged]
the Relevant Extracts of query results) with their clients. Clients of IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates will not have access to any Appropriate Software Tool for the purpose of CTSI. Clients of IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates will, should they request to see results of a particular CTSI analysis from IQVIA
Ltd., IQVIA Technology Services
Ltd. or their Affiliates, receive a limited view of CTSI results consisting
[18 words unchanged]
for a given analysis, ranked by estimated numbers of patients per site.
All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by "Personnel " (as defined within the Data Sharing Framework Contract i.e. employees, agents and contractors of the Data Recipient) who may have access to that data.
Expected measurable benefits
[1 paragraph unchanged]
• accelerating study start-up through faster site identification and patient recruitment into
[14 words unchanged]
development, especially for diseases that are rare and/or difficult to treat. IQVIA
Ltd., IQVIA Technology Services
Ltd. and their Affiliates work across all major disease areas including cardiovascular diseases, oncology, paediatric indications, and many other less common indications.
[4 paragraphs unchanged]
Benefits reported
Clinical trials are often multi-year projects for which results are only available
[17 words unchanged]
impact of HES data on the trials that have been supported since
January
October
2021. This issue is compounded by many initial steps that are required even before running a trial, such as planning, protocol reviews, site selection, start-up and enrolment.
However, as of September
2021,
2022,
IQVIA Ltd. and its Affiliates were supporting
36
28
ongoing trials, including
10 haematology, 5
8 hematology, 6
oncology and
9
6
rare disease studies, that referenced HES data.
(5 in planning / start-up, 18 enrolling, and 2 open for enrolment, 3 on hold, and 8 in development)
(4 Closed to enrolment/24 Enrolling)
–
215
91
sites are
50%
Initiated while
82
178
patients have been enrolled.
Of these
36
28
studies,
four
9
have achieved greater than 50% enrolment.
Based on the
9
3
projects
(robust non-COVID trials)
closed to enrolment
in 2021, we
between Oct 2021-Sep 2022, IQVIA Ltd.
have observed:
•
69%
90%
average improvement for recruitment rate vs the historic comparator
(N=8)
(N=3)
• 5% reduction of recruitment duration vs current contracted timelines (N=7)
• 10% reduction of non-enrollers vs the historic comparator (N=3)
• 10% average reduction in screen failure rate vs initial strategy (N=4)
• 42% reduction of recruitment duration vs the historic comparator (N=3)
• 66 days average reduction in site identification timelines (N=5)
• 28% average improvement for recruitment rate vs initial strategy (N=3)
• 36% average reduction in screen failure rate vs initial strategy (N=3)
[1 paragraph unchanged]
Unchanged: Expected output.
Objective for processing
IQVIA Ltd is a commercial company which generates profit from providing services and solutions, including analysis, interpretation and reports, to its customers. Those analyses, interpretations and reports assist such customers in supporting the understanding of care pathways, delivering clarity to hospitals on their use of medicines, enabling the development of diagnostic algorithms, enabling patients to be recruited to trials, and supporting healthcare commissioners and providers in achieving exceptional Data quality. These services can enable the development of health economic models that evaluate care delivery in relation to outcomes achieved for the patient and in so doing, help advance and benefit healthcare in a variety of different ways.
The services to which this Data Sharing Agreement (DSA) relates are to be provided by IQVIA Ltd. and any companies that are part of the same group of companies as those entities anywhere in the world (an “Affiliate”). For the avoidance of doubt, the only access Affiliates will have to the data provided hereunder will be to aggregated and small-number suppressed data.
Affiliates are not clients. Affiliates are companies that are part of the same group of companies as IQVIA Ltd. Clients are companies external to IQVIA Ltd. and/or their Affiliates.
The territory of use for the data under this Agreement is restricted to England and Wales.
IQVIA Ltd is the sole controller who process the data for the purposes described within this DSA.
The Legal basis for processing of personal data relating to patient health is under Article 9(2)(j)of the GDPR - Processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. The data subjects’ interests and fundamental rights are protected through appropriate minimisation of fields; protection of the data in a secure environment and guaranteeing secure destruction at any stage at the request of NHS Digital or after a defined period on completion of the project.
IQVIA are processing the data according to their legitimate interests. This is covered under the GDPR Article 6(1)(f) - This work is necessary for the purposes of the legitimate interests pursued by the controller except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child. As set out in the legitimate interest assessment - the data requested is to help achieve the following:
Care Pathway Analysis,
Hospital Feedback services,
Benchmarking,
Diagnostic algorithm development studies,
Epidemiology studies,
Health economics and outcomes research studies,
Trust data quality reviews,
Clinical trial analysis.
The services listed above are examples which provide benefits to the NHS. The provision of these services is contingent on the supply of HES data. Delivering these services is seen to be in the interest of the data subjects within HES. A full description of these benefits and their associated outcomes are provided under DARS-NIC-373563-N8Z9J In this DSA only benefits associated with Clinical Trial Site Identification (CTSI) analysis are described in full.
IQVIA Ltd. already have a DSA for pseudonymised record-level HES data (DARS-NIC-373563-N8Z9J) (the “Existing DSA”) pursuant to which IQVIA Ltd. are permitted to use HES data via one or more appropriate software applications. The software application is used to display HES data, with data aggregated and small number suppressed in line with the HES analysis guide and is controlled and auditable. Users are given role-based access to these applications, which allow users to perform analyses on aggregated HES data and data from other sources and then view graphs and tables. The analyses may be stratified by diagnosis, organisation and other parameters. The purpose of this DSA which is independent of the Existing DSA (DARS-NIC-373563-N8Z9J), is a request for IQVIA Ltd. and their Affiliates to use any such appropriate software application (an “Appropriate Software Tool”), in order to provide a further permitted service, (bespoke aggregations with small numbers suppressed in line with the HES analysis guide based on the record-level data provided) as described below. This DSA permits the re-use of the pseudonymised HES APC, HES OP, HES A&E and ECDS data received under DARS-NIC-373563-N8Z9J for the purpose of supporting IQVIA run its CTSI service. In line with the GDPR Principle of Data Minimisation IQVIA Ltd have only requested fields that have been deemed necessary for the purpose of this work and the work outlined in DARS-NIC-373563-N8Z9J.
Clinical Trial Site Identification services
IQVIA Ltd. and their Affiliates will use the HES data via an Appropriate Software Tool to perform CTSI. Affiliates will only access the HES data where it is aggregated with small numbers suppressed in line with the HES analysis guide. CTSI consists of the production of lists of hospital sites with estimates of the size of the patient population at those sites, and lists of physicians affiliated with those sites (by cross-referencing site names and National Administrative Codes Service (NACS) codes against internal data sources of IQVIA Ltd. and their Affiliates); identification of the presence of referral networksʹ data on patients being transferred between sites; and visualisation of the above analyses, e.g. heat maps to show patient density. The purpose of these analyses is to determine whether clinical trials are feasible based on site and patient availability and to advise external clients of the above. There are no alternative, less intrusive ways of achieving the purpose. Examples of the clients of IQVIA Ltd. and their Affiliates are described below.
Note that, for the purpose of CTSI services, IQVIA Ltd. and their Affiliates will only use HES data that has been aggregated and small number suppressed through the use of an Appropriate Software Tool.
Clients of IQVIA Ltd. and their Affiliates
CTSI services will only be provided to the following types of organisations:
• Life sciences industry, such as
o Clinical research organisations (CROs)
o Pharmaceutical companies
o Medical device companies
• Providers of healthcare services, such as
o Clinical Commissioning Groups/Integrated Care Systems
o Commissioning Support Units (CSUs)
o Hospital Trusts
o Private secondary care providers
o Mental Health trusts
o Community Provider Trusts
o Pharmacies
o NHS England
• Universities
• Life sciences industry associations such as the Association of the British Pharmaceutical Industry (ABPI)
Examples of life sciences industry organisations include large pharmaceutical companies engaged in research and development of new medicines.
The specific organisations and the number of organisations to whom IQVIA Ltd. and their Affiliates provide products and services changes regularly as the global healthcare market is dynamic: the products, therapies and services required by healthcare providers change over time, as do the suppliers of these products, therapies and services.
Third parties to whom IQVIA Ltd. and their Affiliates shall provide CTSI analyses and results will only see aggregated and small number suppressed data. Data will not be provided in record level form to any third party. IQVIA Ltd. and their Affiliates understand the importance of data minimisation. IQVIA Ltd. and their Affiliates will not use outputs for commercial/marketing purposes.
IQVIA Ltd.’s requirements of HES Data
The following paragraphs outline IQVIA Ltd.’s and their Affiliates’ requirement for national, timely HES data covering several years for the purposes of CTSI.
• IQVIA Ltd. require national data to analyse estimated patient populations at all hospitals in England and Wales and compare these with similar estimates of patient populations in other countries in which IQVIA Ltd. and their Affiliates undertake CTSI (using data sources specific to those countries). This information helps clients of IQVIA Ltd. and their Affiliates to select suitable countries in which to recruit patients into clinical trials, in order to develop new medicines and treatments for patients.
• IQVIA Ltd. require timely data because the clients to whom IQVIA Ltd. and their Affiliates provide CTSI analyses and results need to make decisions based on the most up-to-date information. Clients of IQVIA Ltd. and their Affiliates are often interested in patient populations who have been treated with medicines or treatments that are new to the healthcare market and whose utilisation will only be measurable in the most up-to-date HES data. This information can help clients of IQVIA Ltd. and their Affiliates decide how best to develop cheaper competing medicines and treatments and bring them to market, which in turn can reduce the cost to healthcare providers and the NHS of providing patient care.
• IQVIA Ltd. require historic data to enable CTSI analyses to provide insight into changes in patient populations over time. Clients of IQVIA Ltd. and their Affiliates are often interested in how patient populations are treated in different ways as new medicines and treatments become available, making certain categories of patients more or less frequent over time. In addition, clinical trials are often conducted over long periods of time (often a number of years). Historic data provides more accurate estimates of the size of patient populations at hospitals over a multi-year period than extrapolations from more recent data covering a shorter period.
Expected output
As stated under “Processing Activities", Relevant Extracts from an Appropriate Software Tool will be used for CTSI, the outputs of which shall consist of a list of hospital sites with estimates of the size of the patient population at those sites, a list of physicians affiliated with those sites (based on physician data internally held by IQVIA Ltd.), and visualisations of the CTSI Analysis; all of these outputs together shall comprise the “CTSI Outputs". The CTSI Outputs shall be produced to meet the previously stated purpose. Outputs will only contain aggregate level data with small numbers suppressed in line with the HES analysis guide, or estimates of patient numbers that are based on such aggregated and small number suppressed data.
CTSI Outputs shall occasionally be reported in journal articles or conference presentations. Examples of relevant industry conferences where CTSI Outputs may be reported include the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Drug Information Association (DIA) conferences.
Benefits reported
Clinical trials are often multi-year projects for which results are only available at the end of the research study. As such, it is too early to gauge the full impact of HES data on the trials that have been supported since October 2021. This issue is compounded by many initial steps that are required even before running a trial, such as planning, protocol reviews, site selection, start-up and enrolment.
However, as of September 2022, IQVIA Ltd. and its Affiliates were supporting 28 ongoing trials, including 8 hematology, 6 oncology and 6 rare disease studies, that referenced HES data. (4 Closed to enrolment/24 Enrolling) – 91 sites are Initiated while 178 patients have been enrolled.
Of these 28 studies, 9 have achieved greater than 50% enrolment.
Based on the 3 projects (robust non-COVID trials) closed to enrolment between Oct 2021-Sep 2022, IQVIA Ltd. have observed:
• 90% average improvement for recruitment rate vs the historic comparator (N=3)
• 10% reduction of non-enrollers vs the historic comparator (N=3)
• 42% reduction of recruitment duration vs the historic comparator (N=3)
• 28% average improvement for recruitment rate vs initial strategy (N=3)
• 36% average reduction in screen failure rate vs initial strategy (N=3)
Without access to this HES data, it would not have been possible to enrol these patients into clinical trials. This has also enabled patients to receive cutting-edge therapies far sooner than would ordinarily be possible.
DARS-NIC-210151-K9C7G-v4.3 6 December 2021 to 5 December 2022
- Title
- HES data for IQVIA clinical trial site identification
- Commercial
- Yes
- Sublicensing
- No
- Datasets
- 4
- Files released
- 0
Datasets: Emergency Care Data Set (ECDS); Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Outpatients (HES OP)
What changed from DARS-NIC-210151-K9C7G-v3.3
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2021-12-06 | |
| End date | 2022-12-05 |
Objective for processing
About IQVIA
[3 paragraphs unchanged]
The territory of use for the data under this Agreement is
restricted to
England and Wales.
IQVIA Ltd and IQVIA Technology Services Ltd are joint data controllers who process the data for the purposes described within this Data Sharing Agreement.
[1 paragraph unchanged]
IQVIA are processing the data according to their legitimate interests. This is
[60 words unchanged]
legitimate interest assessment - the data requested is to help achieve the
following examples:
following:
[8 paragraphs unchanged]
The services listed above are examples which provide benefits to the NHS.
[30 words unchanged]
full description of these benefits and their associated outcomes are provided under
DARS-NIC-37363.
DARS-NIC-373563-N8Z9J
In this DSA only benefits associated with
CTSI
Clinical Trial Site Identification (CTSI)
analysis are described in full.
These details can be found in section 5d.
IQVIA Ltd. and IQVIA Technology Services Ltd. already have a Data Sharing
[158 words unchanged]
HES analysis guide based on the record-level data provided) as described below.
This Data Sharing Agreement permits the re-use of the pseudonymised HES APC, HES OP, HES A&E and ECDS data received under DARS-NIC-373563-N8Z9J for the purpose of supporting IQVIA run its CTSI service. In line with the GDPR Principle of Data Minimisation IQVIA Ltd and IQVIA Technology Services Ltd have only requested fields that have been deemed necessary for the purpose of this work and the work outlined in DARS-NIC-373563-N8Z9J.
[1 paragraph unchanged]
IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates will use the HES data via an Appropriate Software Tool to perform Clinical Trial Site Identification Services (CTSI).
Affiliates
Affiliate s
will only access the HES data where it is aggregated with small
[103 words unchanged]
site and patient availability and to advise external clients of the above.
There are no alternative, less intrusive ways of achieving the purpose.
Examples of the clients of IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates are described below.
[8 paragraphs unchanged]
o Clinical Commissioning
Groups
Groups/Integrated Care Systems
[7 paragraphs unchanged]
o Public Health England
[10 paragraphs unchanged]
Processing activities
No data flows into NHS Digital as part of this Agreement.
This Agreement permits the re-use
of an aggregated sub-set
of data already held by the data controllers under
DARS-NIC373563-N8Z9J.
DARS-NIC-373563-N8Z9J.
No data linkage will take place with the data being accessed under this
agreement,
agreement.
[26 paragraphs unchanged]
Expected measurable benefits
[5 paragraphs unchanged]
The benefits above relate to the CTSI analysis alone, additional benefits are realised under
DAS-NIC-37363
DARS-NIC-373563-N8Z9J
including changes in patient care, reduction in costs, uptake and monitoring of policy.
Benefits reported
Clinical trials are often multi-year projects for which results are only available
[18 words unchanged]
of HES data on the trials that have been supported since January
2019.
2021.
This issue is compounded by many initial steps that are required even before running a trial, such as planning, protocol reviews, site selection, start-up and enrolment.
However, as of
August 2020,
September 2021,
IQVIA Ltd. and its Affiliates were supporting
42
36
ongoing trials, including
12
10 haematology, 5
oncology and
nine
9
rare disease studies, that referenced HES
data (12
data. (5
in planning / start-up,
22
18
enrolling,
two
and 2 open for enrolment, 3
on hold, and
six closed to enrolment)
8 in development)
–
56
215
sites
had been initiated
are 50% Initiated
while
111
82
patients
had
have
been enrolled.
Of these 42 trials, twenty actively used HES data-driven insights in site selection and patient enrolment. Out of those 20 studies, five were having greater than 50% recruitment and three were closed to enrolment.
Based on the three projects closed to enrolment and eleven that had completed site identification (albeit a small sample size), we observed:
Of these 36 studies, four have achieved greater than 50% enrolment.
• 25% average improvement for recruitment rate vs the historic comparator;
Based on the 9 projects closed to enrolment in 2021, we have observed:
• 46% average reduction in ‘Days from SIV (Site Initiation Visit) to FPI (First Patient In)’;
• 69% average improvement for recruitment rate vs the historic comparator (N=8)
• 31% average reduction in site identification timelines.
• 5% reduction of recruitment duration vs current contracted timelines (N=7)
• 10% average reduction in screen failure rate vs initial strategy (N=4)
• 66 days average reduction in site identification timelines (N=5)
[1 paragraph unchanged]
Unchanged: Expected output.
Objective for processing
IQVIA is a business comprised of a number of legal entities which provide technology and services to healthcare. IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates are commercial organisations who profit from providing services for the benefit of Health and Social Care. Please see section 5e for further information on the commercial nature of IQVIA and how it affects the use of data.
The services to which this agreement relates are to be provided by IQVIA Ltd., IQVIA Technology Services Ltd. and any companies that are part of the same group of companies as those entities anywhere in the world (an “Affiliate”). For the avoidance of doubt, the only access Affiliates will have to the data provided hereunder will be to aggregated and small-number suppressed data.
Affiliates are not clients. Affiliates are companies that are part of the same group of companies as IQVIA Ltd. and IQVIA Technology Services Ltd. Clients are companies external to IQVIA Ltd., IQVIA Technology Services Ltd. and/or their Affiliates.
The territory of use for the data under this Agreement is restricted to England and Wales.
IQVIA Ltd and IQVIA Technology Services Ltd are joint data controllers who process the data for the purposes described within this Data Sharing Agreement.
The Legal basis for processing of personal data relating to patient health is under Article 9(2)(j)of the GDPR - Processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. The data subjects’ interests and fundamental rights are protected through appropriate minimisation of fields; protection of the data in a secure environment and guaranteeing secure destruction at any stage at the request of NHS Digital or after a defined period on completion of the project.
IQVIA are processing the data according to their legitimate interests. This is covered under the GDPR Article 6(1)(f) - This work is necessary for the purposes of the legitimate interests pursued by the controller except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child. As set out in the legitimate interest assessment - the data requested is to help achieve the following:
Care Pathway Analysis,
Hospital Feedback services,
Benchmarking,
Diagnostic algorithm development studies,
Epidemiology studies,
Health economics and outcomes research studies,
Trust data quality reviews,
Clinical trial analysis.
The services listed above are examples which provide benefits to the NHS. The provision of these services is contingent on the supply of HES data. Delivering these services is seen to be in the interest of the data subjects within HES. A full description of these benefits and their associated outcomes are provided under DARS-NIC-373563-N8Z9J In this DSA only benefits associated with Clinical Trial Site Identification (CTSI) analysis are described in full.
IQVIA Ltd. and IQVIA Technology Services Ltd. already have a Data Sharing Agreement (DSA) for pseudonymised record-level HES data (DARS-NIC-373563) (the “Existing DSA”) pursuant to which IQVIA Ltd. and IQVIA Technology Services Ltd. are permitted to use HES data via one or more appropriate software applications. The software application is used to display HES data, with data aggregated and small number suppressed in line with the HES analysis guide and is controlled and auditable. Users are given role-based access to these applications, which allow users to perform analyses on aggregated HES data and data from other sources and then view graphs and tables. The analyses may be stratified by diagnosis, organisation and other parameters. The purpose of this DSA which is independent of the Existing DSA (DARS-NIC-373563), is a request for IQVIA Ltd. and IQVIA Technology Services Ltd. and their Affiliates to use any such appropriate software application (an “Appropriate Software Tool”), in order to provide a further permitted service, (bespoke aggregations with small numbers suppressed in line with the HES analysis guide based on the record-level data provided) as described below. This Data Sharing Agreement permits the re-use of the pseudonymised HES APC, HES OP, HES A&E and ECDS data received under DARS-NIC-373563-N8Z9J for the purpose of supporting IQVIA run its CTSI service. In line with the GDPR Principle of Data Minimisation IQVIA Ltd and IQVIA Technology Services Ltd have only requested fields that have been deemed necessary for the purpose of this work and the work outlined in DARS-NIC-373563-N8Z9J.
Clinical Trial Site Identification services
IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates will use the HES data via an Appropriate Software Tool to perform Clinical Trial Site Identification Services (CTSI). Affiliate s will only access the HES data where it is aggregated with small numbers suppressed in line with the HES analysis guide. CTSI consists of the production of lists of hospital sites with estimates of the size of the patient population at those sites, and lists of physicians affiliated with those sites (by cross-referencing site names and site NACS codes against internal data sources of IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates); identification of the presence of referral networksʹ data on patients being transferred between sites; and visualisation of the above analyses, e.g. heat maps to show patient density. The purpose of these analyses is to determine whether clinical trials are feasible based on site and patient availability and to advise external clients of the above. There are no alternative, less intrusive ways of achieving the purpose. Examples of the clients of IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates are described below.
Note that, for the purpose of CTSI services, IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates will only use HES data that has been aggregated and small number suppressed through the use of an Appropriate Software Tool.
Clients of IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates
CTSI services will only be provided to the following types of organisations:
• Life sciences industry, such as
o Clinical research organisations (CROs)
o Pharmaceutical companies
o Medical device companies
• Providers of healthcare services, such as
o Clinical Commissioning Groups/Integrated Care Systems
o Commissioning Support Units (CSUs)
o Hospital Trusts
o Private secondary care providers
o Mental Health trusts
o Community Provider Trusts
o Pharmacies
o NHS England
• Universities
• Life sciences industry associations such as the Association of the British Pharmaceutical Industry (ABPI)
Examples of life sciences industry organisations include large pharmaceutical companies engaged in research and development of new medicines.
The specific organisations and the number of organisations to whom IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates provide products and services changes regularly as the global healthcare market is dynamic: the products, therapies and services required by healthcare providers change over time, as do the suppliers of these products, therapies and services.
Third parties to whom IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates shall provide CTSI analyses and results will only see aggregated and small number suppressed data. Data will not be provided in record level form to any third party. IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates understand the importance of data minimisation. IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates will not use outputs for commercial/marketing purposes.
IQVIA Ltd.’s, and IQVIA Technology Services Ltd.’s Requirements of HES Data
The following paragraphs outline IQVIA Ltd.’s, IQVIA Technology Services Ltd.’s and their Affiliates’ requirement for national, timely HES data covering several years for the purposes of CTSI.
• IQVIA Ltd. and IQVIA Technology Services Ltd. require national data to analyse estimated patient populations at all hospitals in England and Wales and compare these with similar estimates of patient populations in other countries in which IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates undertake CTSI (using data sources specific to those countries). This information helps clients of IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates to select suitable countries in which to recruit patients into clinical trials, in order to develop new medicines and treatments for patients.
• IQVIA Ltd. and IQVIA Technology Services Ltd. require timely data because the clients to whom IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates provide CTSI analyses and results need to make decisions based on the most up-to-date information. Clients of IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates are often interested in patient populations who have been treated with medicines or treatments that are new to the healthcare market and whose utilisation will only be measurable in the most up-to-date HES data. This information can help clients of IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates decide how best to develop cheaper competing medicines and treatments and bring them to market, which in turn can reduce the cost to healthcare providers and the NHS of providing patient care.
• IQVIA Ltd., and IQVIA Technology Services Ltd. require historic data to enable CTSI analyses to provide insight into changes in patient populations over time. Clients of IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates are often interested in how patient populations are treated in different ways as new medicines and treatments become available, making certain categories of patients more or less frequent over time. In addition, clinical trials are often conducted over long periods of time (often a number of years). Historic data provides more accurate estimates of the size of patient populations at hospitals over a multi-year period than extrapolations from more recent data covering a shorter period.
Expected output
As stated under “Processing Activities", Relevant Extracts from an Appropriate Software Tool will be used for CTSI, the outputs of which shall consist of a list of hospital sites with estimates of the size of the patient population at those sites, a list of physicians affiliated with those sites (based on physician data internally held by IQVIA Ltd.), and visualisations of the CTSI Analysis; all of these outputs together shall comprise the “CTSI Outputs". The CTSI Outputs shall be produced to meet the previously stated purpose. Outputs will only contain aggregate level data with small numbers suppressed in line with the HES analysis guide, or estimates of patient numbers that are based on such aggregated and small number suppressed data.
CTSI Outputs shall occasionally be reported in journal articles or conference presentations. Examples of relevant industry conferences where CTSI Outputs may be reported include the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Drug Information Association (DIA) conferences.
Benefits reported
Clinical trials are often multi-year projects for which results are only available at the end of the research study. As such, it is too early to gauge the full impact of HES data on the trials that have been supported since January 2021. This issue is compounded by many initial steps that are required even before running a trial, such as planning, protocol reviews, site selection, start-up and enrolment.
However, as of September 2021, IQVIA Ltd. and its Affiliates were supporting 36 ongoing trials, including 10 haematology, 5 oncology and 9 rare disease studies, that referenced HES data. (5 in planning / start-up, 18 enrolling, and 2 open for enrolment, 3 on hold, and 8 in development) – 215 sites are 50% Initiated while 82 patients have been enrolled.
Of these 36 studies, four have achieved greater than 50% enrolment.
Based on the 9 projects closed to enrolment in 2021, we have observed:
• 69% average improvement for recruitment rate vs the historic comparator (N=8)
• 5% reduction of recruitment duration vs current contracted timelines (N=7)
• 10% average reduction in screen failure rate vs initial strategy (N=4)
• 66 days average reduction in site identification timelines (N=5)
Without access to this HES data, it would not have been possible to enrol these patients into clinical trials. This has also enabled patients to receive cutting-edge therapies far sooner than would ordinarily be possible.
DARS-NIC-210151-K9C7G-v3.3 6 December 2020 to 5 December 2021
- Title
- HES data for IQVIA clinical trial site identification
- Commercial
- Yes
- Sublicensing
- No
- Datasets
- 4
- Files released
- 0
Datasets: Emergency Care Data Set (ECDS); Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Outpatients (HES OP)
What changed from DARS-NIC-210151-K9C7G-v2.2
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2020-12-06 | |
| End date | 2021-12-05 | |
| Hospital Episode Statistics Accident and Emergency (HES A and E): legal basis | Health and Social Care Act 2012 - s261 - 'Other dissemination of information' | |
| Hospital Episode Statistics Admitted Patient Care (HES APC): legal basis | Health and Social Care Act 2012 - s261 - 'Other dissemination of information' | |
| Hospital Episode Statistics Outpatients (HES OP): legal basis | Health and Social Care Act 2012 - s261 - 'Other dissemination of information' |
Data controllers:
− IQVIA SOLUTIONS UK LIMITED
Datasets: + Emergency Care Data Set (ECDS)
Objective for processing
[1 paragraph unchanged]
IQVIA is a business comprised of a number of legal entities which provide technology and services to healthcare.
IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates are commercial organisations who profit from providing services for the benefit of Health and Social Care. Please see section 5e for further information on the commercial nature of IQVIA and how it affects the use of data.
This agreement is a request to amend the agreement currently in place for psuedonymised record-level HES data to include an additional data controller IQVIA Ltd. The IQVIA UK group is consolidating the majority of its UK business within IQVIA Ltd. IQVIA will be transferring the business and assets (including contracts) of IQVIA
The services to which this agreement relates are to be provided by IQVIA Ltd., IQVIA Technology Services Ltd. and any companies that are part of the same group of companies as those entities anywhere in the world (an “Affiliate”). For the avoidance of doubt, the only access Affiliates will have to the data provided hereunder will be to aggregated and small-number suppressed data.
Solutions UK Limited into IQVIA Ltd. Throughout this agreement IQVIA Solutions UK Limited, IQVIA Ltd and IQVIA Technology Services Ltd. will be referred to collectively as IQVIA.
Affiliates are not clients. Affiliates are companies that are part of the same group of companies as IQVIA Ltd. and IQVIA Technology Services Ltd. Clients are companies external to IQVIA Ltd., IQVIA Technology Services Ltd. and/or their Affiliates.
The services to which this agreement relates are to be provided by IQVIA and any companies that are part of the same group of companies as IQVIA anywhere in the world (an ”Affiliate”).
The territory of use for the data under this Agreement is England and Wales.
Affiliates are not clients. Affiliates are companies that are part of the same group of companies as IQVIA, and so the clients of affiliates are the clients of IQVIA. Clients are companies external to IQVIA.
[1 paragraph unchanged]
IQVIA are processing the data
in line with their goals as part of
according to
their legitimate interests. This is covered under the GDPR Article 6(1)(f) -
[55 words unchanged]
assessment - the data requested is to help achieve the following examples:
[8 paragraphs unchanged]
IQVIA already has a Data Sharing Agreement (DSA) for psuedonymised record-level HES data (DARS-NIC-373563) (the “Existing DSA”) pursuant to which IQVIA is permitted to use HES data via one or more appropriate software applications. The software application is used to display HES data, with data aggregated and small number suppressed in line with the HES analysis guide and is controlled and auditable. Users are given role-based access to these applications, which allow users to perform analyses on aggregated HES data and data from other sources and then view graphs and tables. The analyses may be stratified by diagnosis, organisation and other parameters. The purpose of this DSA which is independent of the Existing DSA (DARS-NIC-373563), is a request for IQVIA and its Affiliates to use any such appropriate software application (an “Appropriate Software Tool”), in order to provide a further permitted service, (bespoke aggregations with small numbers suppressed in line with the HES analysis guide based on the record-level data provided) as described below.
The services listed above are examples which provide benefits to the NHS. The provision of these services is contingent on the supply of HES data. Delivering these services is seen to be in the interest of the data subjects within HES. A full description of these benefits and their associated outcomes are provided under DARS-NIC-37363. In this DSA only benefits associated with CTSI analysis are described in full. These details can be found in section 5d.
IQVIA Ltd. and IQVIA Technology Services Ltd. already have a Data Sharing Agreement (DSA) for pseudonymised record-level HES data (DARS-NIC-373563) (the “Existing DSA”) pursuant to which IQVIA Ltd. and IQVIA Technology Services Ltd. are permitted to use HES data via one or more appropriate software applications. The software application is used to display HES data, with data aggregated and small number suppressed in line with the HES analysis guide and is controlled and auditable. Users are given role-based access to these applications, which allow users to perform analyses on aggregated HES data and data from other sources and then view graphs and tables. The analyses may be stratified by diagnosis, organisation and other parameters. The purpose of this DSA which is independent of the Existing DSA (DARS-NIC-373563), is a request for IQVIA Ltd. and IQVIA Technology Services Ltd. and their Affiliates to use any such appropriate software application (an “Appropriate Software Tool”), in order to provide a further permitted service, (bespoke aggregations with small numbers suppressed in line with the HES analysis guide based on the record-level data provided) as described below.
[1 paragraph unchanged]
IQVIA
Ltd., IQVIA Technology Services Ltd.
and
its
their
Affiliates will use the HES data via an Appropriate Software Tool to
[57 words unchanged]
those sites (by cross-referencing site names and site NACS codes against internal
data sources of
IQVIA
group of companies data sources);
Ltd., IQVIA Technology Services Ltd. and their Affiliates);
identification of the presence of referral
networks ʹdata
networksʹ data
on patients being transferred between sites; and visualisation of the above analyses,
[24 words unchanged]
patient availability and to advise external clients of the above. Examples of
the clients of
IQVIA
group of companies’ clients
Ltd., IQVIA Technology Services Ltd. and their Affiliates
are described below.
Note that, for the purpose of CTSI services, IQVIA
Ltd., IQVIA Technology Services Ltd.
and
its
their
Affiliates will only use HES data that has been aggregated and small number suppressed through the use of an Appropriate Software Tool.
IQVIA’s Clients
Clients of IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates
[18 paragraphs unchanged]
The specific organisations and the number of organisations to whom IQVIA
Ltd., IQVIA Technology Services Ltd.
and
its
their
Affiliates provide products and services changes regularly as the global healthcare market
[12 words unchanged]
over time, as do the suppliers of these products, therapies and services.
Third parties to whom IQVIA
Ltd., IQVIA Technology Services Ltd.
and
its
their
Affiliates shall provide CTSI analyses and results will only see aggregated and
[6 words unchanged]
not be provided in record level form to any third party. IQVIA
understands
Ltd., IQVIA Technology Services Ltd. and their Affiliates understand
the importance of data minimisation. IQVIA
Ltd., IQVIA Technology Services Ltd.
and
affiliates
their Affiliates
will not use outputs for commercial/marketing purposes.
IQVIA’s
IQVIA Ltd.’s, and IQVIA Technology Services Ltd.’s
Requirements of HES Data
The following paragraphs outline
IQVIA's
IQVIA Ltd.’s, IQVIA Technology Services Ltd.’s
and
its
their
Affiliates’ requirement for national, timely HES data covering several years for the purposes of CTSI.
• IQVIA
Ltd. and IQVIA Technology Services Ltd.
require national
(UK)
data to analyse estimated patient populations at all hospitals in
the UK
England and Wales
and compare these with similar estimates of patient populations in other countries in which IQVIA
Ltd., IQVIA Technology Services Ltd.
and
its
their
Affiliates undertake CTSI (using data sources specific to those countries). This information helps clients of IQVIA
Ltd., IQVIA Technology Services Ltd.
and
its
their
Affiliates to select suitable countries in which to recruit patients into clinical trials, in order to develop new medicines and treatments for patients.
• IQVIA
Ltd. and IQVIA Technology Services Ltd.
require timely data because the clients to whom IQVIA
Ltd., IQVIA Technology Services Ltd.
and
its
their
Affiliates provide CTSI analyses and results need to make decisions based on the most up-to-date information. Clients of IQVIA
Ltd., IQVIA Technology Services Ltd.
and
its
their
Affiliates are often interested in patient populations who have been treated with
[18 words unchanged]
the most up-to-date HES data. This information can help clients of IQVIA
Ltd., IQVIA Technology Services Ltd.
and
its
their
Affiliates decide how best to develop cheaper competing medicines and treatments and
[9 words unchanged]
the cost to healthcare providers and the NHS of providing patient care.
• IQVIA
Ltd., and IQVIA Technology Services Ltd.
require historic data to enable CTSI analyses to provide insight into changes in patient populations over time. Clients of IQVIA
Ltd., IQVIA Technology Services Ltd.
and
its
their
Affiliates are often interested in how patient populations are treated in different
[52 words unchanged]
multi-year period than extrapolations from more recent data covering a shorter period.
Processing activities
No Data Linkage will take place with the data being accessed under this agreement. It will not be possible to follow individual patient records through the workflow proposed in this section.
This Agreement permits the re-use of data already held by the data controllers under DARS-NIC373563-N8Z9J.
IQVIA will receive Hospital Episode Statistics data from NHS Digital and will apply derivations. No linkage is carried out to other datasets. In the context of this application/agreement applying derivations does not mean linking to other patient level information. In this application/agreement, applying derivations means that IQVIA will use non-identifiable data to derive new information. For example, length of stay is approximated using the relationship between admission and discharge dates and the cost of an admission is approximated using the NHS payment by results tariff.
No data linkage will take place with the data being accessed under this agreement,
Please note that, for the purpose of CTSI services, IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates will only use HES data that has been aggregated with small numbers suppressed through the use of an Appropriate Software Tool, in line with the HES analysis guide.
Clients and end users will have access to aggregated data with small number suppressed and are compliant with the HES Analysis Guide.
Access to patient level data is not provided under this DSA.
IQVIA Ltd. and IQVIA Technology Services Ltd. will receive Hospital Episode Statistics data from NHS Digital and will apply derivations. No linkage is carried out to other datasets. In the context of this application/agreement applying derivations does not mean linking to other patient level information. In this application/agreement, applying derivations means that IQVIA Ltd. and IQVIA Technology Services Ltd. will use non-identifiable data to derive new information. For example, length of stay is approximated using the relationship between admission and discharge dates and the cost of an admission is approximated using the NHS payment by results tariff.
[1 paragraph unchanged]
All data visualisation and benchmarking tools are hosted by
IQVIA.
IQVIA Ltd. and IQVIA Technology Services Ltd.
All data seen by end users is aggregated; small numbers are suppressed
[8 words unchanged]
Usage of these tools is auditable and role-based access controls are applied.
[3 paragraphs unchanged]
Data analysis will then be performed on the Relevant Extracts using software
[43 words unchanged]
programming languages. Site names from the Relevant Extracts will be cross-referenced with
the IQVIA group of companies’
physician data
internally held
physician data
by IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates
to identify (from
the IQVIA group of companies’
such internally held
physician data) the physicians affiliated with each site (“CTSI Analysis”).
IQVIA
Ltd., IQVIA Technology Services Ltd., and their Affiliates
would identify which
doctors work at the
hospitals that appear in HES results.
This would be done by
Then,
taking the NACS code for each hospital in HES and using
it to identify doctors in an IQVIA
a
data asset called
OneKey.
OneKey which is proprietary to IQVIA Ltd, relevant doctors can be identified.
OneKey is a database of health care professionals such as physicians that includes information on a physician’s name, workplace (address, NACS
code͙Ϳ͕speciality,
code͙, speciality,
and other information such as research interests. Physicians are aware of their
[10 words unchanged]
opt out of inclusion as well as to exercise their other rights
(SARs etc).
(SARs, etc.).
The purpose of this work would be to understand whether certain hospitals
[9 words unchanged]
investigators for clinical trials. The data controller for OneKey data is IQVIA
Solutions UK
Ltd.
IQVIA
Ltd., IQVIA Technology Services Ltd. and their Affiliates
will add value to the data beyond what is already provided by NHS Digital.
The employees of
IQVIA
employees
Ltd., IQVIA Technology Services Ltd. and their Affiliates
will apply the knowledge and skills they possess to better understand specific
[34 words unchanged]
in order to evaluate the suitability of such patients for clinical trials.
IQVIA's
IQVIA Ltd.’s, IQVIA Technology Services Ltd.’s and their Affiliates’
prior experience working with specific hospitals on clinical trials will also be incorporated - data alone provided by NHS Digital would not include this.
Relevant Extracts of HES data will be used by employees of IQVIA
or its Affiliates (noting that Affiliates will only have access to data that has been aggregated with small numbers suppressed in line with the HES analysis guide),
Ltd. and IQVIA Technology Services Ltd.
for CTSI Analysis to identify hospitals with suitable patient populations for clinical
[40 words unchanged]
have the most elderly patients with diabetes. This information could then help
the
IQVIA
group of companies
Ltd., IQVIA Technology Services Ltd. and their Affiliates
or clients of
the
IQVIA
group of companies
Ltd., IQVIA Technology Services Ltd. and their Affiliates
to identify which hospitals to contact in order to discuss running clinical
[8 words unchanged]
eventually help to make new treatments for diabetes available in the NHS.
In order to provide the CTSI Services and obtain the Relevant Extracts, employees of IQVIA
Ltd., IQVIA Technology Services Ltd.
and
any of
their Affiliates may be granted access by IQVIA
Ltd. and IQVIA Technology Services Ltd.
to an Appropriate Software Tool for the purpose of obtaining Relevant Extracts
[35 words unchanged]
Data Recipient/licensee hereunder. For the avoidance of doubt, only employees of IQVIA
Solutions UK Limited
Ltd.
and IQVIA Technology Services
Ltd
Ltd.
are permitted to access the non-identified record-level data, however aggregated data with
[13 words unchanged]
data output generated by an Appropriate Software Tool) may be accessed worldwide.
Additionally, it is agreed that the services to be provided by IQVIA
Ltd., IQVIA Technology Services Ltd.
and
its
their
Affiliates in relation to the CTSI Services, and the permitted uses of such relevant data by such third parties, do not constitute Distribution or require a Sub-Licence.
[1 paragraph unchanged]
Many clients of IQVIA
Ltd., IQVIA Technology Services Ltd.
and
its
their
Affiliates are pharmaceutical companies developing and manufacturing treatments for diseases. These companies
[19 words unchanged]
enable them to decide the best locations to run a trial. IQVIA
believes
Ltd. and IQVIA Technology Services Ltd. believe
this provides a health benefit to the UK because these outputs help
[23 words unchanged]
approval and therefore faster access to medicines by patients in the UK.
IQVIA
Solutions UK Limited
Ltd.
and IQVIA Technology Services
Ltd
Ltd.
are themselves part of a multinational group of companies providing the same
[11 words unchanged]
pharmaceutical companies to come to the UK and run clinical trials, IQVIA
Ltd., IQVIA Technology Services Ltd.
and
its
their
Affiliates need to be able to critically assess the feasibility of running
[29 words unchanged]
Appropriate Software Tool and the other data analysis tools available to IQVIA
Ltd., IQVIA Technology Services Ltd.
and
its
their
Affiliates as described in the section on Relevant Extracts. IQVIA
Ltd., IQVIA Technology Services Ltd.
and
its
their
Affiliates will then be able to provide their findings to the relevant pharmaceutical companies, wherever they are based.
Employees of
IQVIA
employees
Ltd., IQVIA Technology Services Ltd. and their Affiliates
with the skills required to perform CTSI Analysis are located in many
[35 words unchanged]
helps to achieve the expected benefits of CTSI, i.e. accelerating study start-up.
The staff of
IQVIA
staff
Ltd., IQVIA Technology Services Ltd. and their Affiliates
are also permitted to work remotely including at home on the data
[6 words unchanged]
access the data (laptops) is a standard build with hard drive encryption.
Note that, in carrying out CTSI Analysis, employees of IQVIA
Ltd., IQVIA Technology Services Ltd.
and
its
their
Affiliates would only be given access to data which has been amalgamated
[59 words unchanged]
HES data) to only allow users (who would be employees of IQVIA
Ltd., IQVIA Technology Services Ltd.
or its Affiliates) to perform the following processing activities:
[1 paragraph unchanged]
• View results of queries
ʹall
(all
results would be aggregated and small number suppressed in line with the HES Analysis Guide
)
• Export results of
queries
queries,
i.e. produce Relevant Extracts of HES Data
In addition to the rights of IQVIA
Ltd. and IQVIA Technology Services Ltd.
hereunder to use the data for the purposes of CTSI Analysis and to make the CTSI Outputs available to
its
their
clients worldwide, it is hereby agreed that any Affiliate
of IQVIA Ltd. and IQVIA Technology Services Ltd.
anywhere in the world may be granted access by IQVIA
Ltd. and IQVIA Technology Services Ltd.
to an Appropriate Software Tool for the purpose of obtaining Relevant Extracts
[31 words unchanged]
Affiliate is not a named Data Recipient/licensee hereunder. Only employees of IQVIA
Solutions UK Limited
Ltd.
and IQVIA Technology Services
Ltd
Ltd.
are permitted to access the non-identified record-level data (i.e. other than data that has been aggregated, with small numbers suppressed in line with the HES Analysis Guide).
Under no circumstances will IQVIA
Ltd., IQVIA Technology Services Ltd.
or
its
their
Affiliates be sharing the direct output of the analyses (i.e. the results of queries or the Relevant Extracts of query results) with
its
their
clients. Clients of IQVIA
Ltd., IQVIA Technology Services Ltd.
and
its
their
Affiliates will not have access to any Appropriate Software Tool for the purpose of CTSI. Clients of IQVIA
Ltd., IQVIA Technology Services Ltd.
and
its
their
Affiliates will, should they request to see results of a particular CTSI analysis from
IQVIA,
IQVIA Ltd., IQVIA Technology Services Ltd. or their Affiliates,
receive a limited view of CTSI results consisting of a list of
[14 words unchanged]
for a given analysis, ranked by estimated numbers of patients per site.
All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by
"Personnel"
"Personnel "
(as defined within the Data Sharing Framework Contract
i.e
i.e.
employees, agents and contractors of the Data Recipient) who may have access to that data.
Expected output
As stated under “Processing Activities", Relevant Extracts from an Appropriate Software Tool
[27 words unchanged]
those sites, a list of physicians affiliated with those sites (based on
physician data internally held by
IQVIA
group internal physician data),
Ltd.),
and visualisations of the CTSI Analysis; all of these outputs together shall
[38 words unchanged]
numbers that are based on such aggregated and small number suppressed data.
[1 paragraph unchanged]
Expected measurable benefits
[1 paragraph unchanged]
• accelerating study start-up through faster site identification and patient recruitment into
[14 words unchanged]
development, especially for diseases that are rare and/or difficult to treat. IQVIA
Ltd., IQVIA Technology Services Ltd. and their Affiliates
work across all major disease areas including cardiovascular diseases, oncology,
pediatric
paediatric
indications, and many other less common indications.
[3 paragraphs unchanged]
The benefits above relate to the CTSI analysis alone, additional benefits are realised under DAS-NIC-37363 including changes in patient care, reduction in costs, uptake and monitoring of policy.
Benefits reported
Clinical trials are often multi-year projects for which results are only available
[16 words unchanged]
full impact of HES data on the trials that have been supported
over the last year.
since January 2019.
This issue is compounded by many initial steps that are required even before running a trial, such as planning, protocol reviews, site selection, start-up and enrolment.
However, as of September 30th 2019, IQVIA is currently running 13 ongoing trials that have used HES data; 7 are in the planning/start-up phase and 6 are enrolling patients. Of these trials, three are in rare diseases, two in oncology, and 14 patients have been enrolled. Without access to this data, it would not have been possible to enrol these patients into clinical trials in these difficult-to-treat and difficult-to-identify diseases. This has also enabled patients to receive cutting-edge therapies far sooner than would ordinarily be possible.
However, as of August 2020, IQVIA Ltd. and its Affiliates were supporting 42 ongoing trials, including 12 oncology and nine rare disease studies, that referenced HES data (12 in planning / start-up, 22 enrolling, two on hold, and six closed to enrolment) – 56 sites had been initiated while 111 patients had been enrolled. Of these 42 trials, twenty actively used HES data-driven insights in site selection and patient enrolment. Out of those 20 studies, five were having greater than 50% recruitment and three were closed to enrolment.
Based on the three projects closed to enrolment and eleven that had completed site identification (albeit a small sample size), we observed:
• 25% average improvement for recruitment rate vs the historic comparator;
• 46% average reduction in ‘Days from SIV (Site Initiation Visit) to FPI (First Patient In)’;
• 31% average reduction in site identification timelines.
Without access to this HES data, it would not have been possible to enrol these patients into clinical trials. This has also enabled patients to receive cutting-edge therapies far sooner than would ordinarily be possible.
Objective for processing
About IQVIA
IQVIA is a business comprised of a number of legal entities which provide technology and services to healthcare. IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates are commercial organisations who profit from providing services for the benefit of Health and Social Care. Please see section 5e for further information on the commercial nature of IQVIA and how it affects the use of data.
The services to which this agreement relates are to be provided by IQVIA Ltd., IQVIA Technology Services Ltd. and any companies that are part of the same group of companies as those entities anywhere in the world (an “Affiliate”). For the avoidance of doubt, the only access Affiliates will have to the data provided hereunder will be to aggregated and small-number suppressed data.
Affiliates are not clients. Affiliates are companies that are part of the same group of companies as IQVIA Ltd. and IQVIA Technology Services Ltd. Clients are companies external to IQVIA Ltd., IQVIA Technology Services Ltd. and/or their Affiliates.
The territory of use for the data under this Agreement is England and Wales.
The Legal basis for processing of personal data relating to patient health is under Article 9(2)(j)of the GDPR - Processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. The data subjects’ interests and fundamental rights are protected through appropriate minimisation of fields; protection of the data in a secure environment and guaranteeing secure destruction at any stage at the request of NHS Digital or after a defined period on completion of the project.
IQVIA are processing the data according to their legitimate interests. This is covered under the GDPR Article 6(1)(f) - This work is necessary for the purposes of the legitimate interests pursued by the controller except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child. As set out in the legitimate interest assessment - the data requested is to help achieve the following examples:
Care Pathway Analysis,
Hospital Feedback services,
Benchmarking,
Diagnostic algorithm development studies,
Epidemiology studies,
Health economics and outcomes research studies,
Trust data quality reviews,
Clinical trial analysis.
The services listed above are examples which provide benefits to the NHS. The provision of these services is contingent on the supply of HES data. Delivering these services is seen to be in the interest of the data subjects within HES. A full description of these benefits and their associated outcomes are provided under DARS-NIC-37363. In this DSA only benefits associated with CTSI analysis are described in full. These details can be found in section 5d.
IQVIA Ltd. and IQVIA Technology Services Ltd. already have a Data Sharing Agreement (DSA) for pseudonymised record-level HES data (DARS-NIC-373563) (the “Existing DSA”) pursuant to which IQVIA Ltd. and IQVIA Technology Services Ltd. are permitted to use HES data via one or more appropriate software applications. The software application is used to display HES data, with data aggregated and small number suppressed in line with the HES analysis guide and is controlled and auditable. Users are given role-based access to these applications, which allow users to perform analyses on aggregated HES data and data from other sources and then view graphs and tables. The analyses may be stratified by diagnosis, organisation and other parameters. The purpose of this DSA which is independent of the Existing DSA (DARS-NIC-373563), is a request for IQVIA Ltd. and IQVIA Technology Services Ltd. and their Affiliates to use any such appropriate software application (an “Appropriate Software Tool”), in order to provide a further permitted service, (bespoke aggregations with small numbers suppressed in line with the HES analysis guide based on the record-level data provided) as described below.
Clinical Trial Site Identification services
IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates will use the HES data via an Appropriate Software Tool to perform Clinical Trial Site Identification Services (CTSI). Affiliates will only access the HES data where it is aggregated with small numbers suppressed in line with the HES analysis guide. CTSI consists of the production of lists of hospital sites with estimates of the size of the patient population at those sites, and lists of physicians affiliated with those sites (by cross-referencing site names and site NACS codes against internal data sources of IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates); identification of the presence of referral networksʹ data on patients being transferred between sites; and visualisation of the above analyses, e.g. heat maps to show patient density. The purpose of these analyses is to determine whether clinical trials are feasible based on site and patient availability and to advise external clients of the above. Examples of the clients of IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates are described below.
Note that, for the purpose of CTSI services, IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates will only use HES data that has been aggregated and small number suppressed through the use of an Appropriate Software Tool.
Clients of IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates
CTSI services will only be provided to the following types of organisations:
• Life sciences industry, such as
o Clinical research organisations (CROs)
o Pharmaceutical companies
o Medical device companies
• Providers of healthcare services, such as
o Clinical Commissioning Groups
o Commissioning Support Units (CSUs)
o Hospital Trusts
o Private secondary care providers
o Mental Health trusts
o Community Provider Trusts
o Pharmacies
o NHS England
o Public Health England
• Universities
• Life sciences industry associations such as the Association of the British Pharmaceutical Industry (ABPI)
Examples of life sciences industry organisations include large pharmaceutical companies engaged in research and development of new medicines.
The specific organisations and the number of organisations to whom IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates provide products and services changes regularly as the global healthcare market is dynamic: the products, therapies and services required by healthcare providers change over time, as do the suppliers of these products, therapies and services.
Third parties to whom IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates shall provide CTSI analyses and results will only see aggregated and small number suppressed data. Data will not be provided in record level form to any third party. IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates understand the importance of data minimisation. IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates will not use outputs for commercial/marketing purposes.
IQVIA Ltd.’s, and IQVIA Technology Services Ltd.’s Requirements of HES Data
The following paragraphs outline IQVIA Ltd.’s, IQVIA Technology Services Ltd.’s and their Affiliates’ requirement for national, timely HES data covering several years for the purposes of CTSI.
• IQVIA Ltd. and IQVIA Technology Services Ltd. require national data to analyse estimated patient populations at all hospitals in England and Wales and compare these with similar estimates of patient populations in other countries in which IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates undertake CTSI (using data sources specific to those countries). This information helps clients of IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates to select suitable countries in which to recruit patients into clinical trials, in order to develop new medicines and treatments for patients.
• IQVIA Ltd. and IQVIA Technology Services Ltd. require timely data because the clients to whom IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates provide CTSI analyses and results need to make decisions based on the most up-to-date information. Clients of IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates are often interested in patient populations who have been treated with medicines or treatments that are new to the healthcare market and whose utilisation will only be measurable in the most up-to-date HES data. This information can help clients of IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates decide how best to develop cheaper competing medicines and treatments and bring them to market, which in turn can reduce the cost to healthcare providers and the NHS of providing patient care.
• IQVIA Ltd., and IQVIA Technology Services Ltd. require historic data to enable CTSI analyses to provide insight into changes in patient populations over time. Clients of IQVIA Ltd., IQVIA Technology Services Ltd. and their Affiliates are often interested in how patient populations are treated in different ways as new medicines and treatments become available, making certain categories of patients more or less frequent over time. In addition, clinical trials are often conducted over long periods of time (often a number of years). Historic data provides more accurate estimates of the size of patient populations at hospitals over a multi-year period than extrapolations from more recent data covering a shorter period.
Expected output
As stated under “Processing Activities", Relevant Extracts from an Appropriate Software Tool will be used for CTSI, the outputs of which shall consist of a list of hospital sites with estimates of the size of the patient population at those sites, a list of physicians affiliated with those sites (based on physician data internally held by IQVIA Ltd.), and visualisations of the CTSI Analysis; all of these outputs together shall comprise the “CTSI Outputs". The CTSI Outputs shall be produced to meet the previously stated purpose. Outputs will only contain aggregate level data with small numbers suppressed in line with the HES analysis guide, or estimates of patient numbers that are based on such aggregated and small number suppressed data.
CTSI Outputs shall occasionally be reported in journal articles or conference presentations. Examples of relevant industry conferences where CTSI Outputs may be reported include the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Drug Information Association (DIA) conferences.
Benefits reported
Clinical trials are often multi-year projects for which results are only available at the end of the research study. As such, it is too early to gauge the full impact of HES data on the trials that have been supported since January 2019. This issue is compounded by many initial steps that are required even before running a trial, such as planning, protocol reviews, site selection, start-up and enrolment.
However, as of August 2020, IQVIA Ltd. and its Affiliates were supporting 42 ongoing trials, including 12 oncology and nine rare disease studies, that referenced HES data (12 in planning / start-up, 22 enrolling, two on hold, and six closed to enrolment) – 56 sites had been initiated while 111 patients had been enrolled. Of these 42 trials, twenty actively used HES data-driven insights in site selection and patient enrolment. Out of those 20 studies, five were having greater than 50% recruitment and three were closed to enrolment.
Based on the three projects closed to enrolment and eleven that had completed site identification (albeit a small sample size), we observed:
• 25% average improvement for recruitment rate vs the historic comparator;
• 46% average reduction in ‘Days from SIV (Site Initiation Visit) to FPI (First Patient In)’;
• 31% average reduction in site identification timelines.
Without access to this HES data, it would not have been possible to enrol these patients into clinical trials. This has also enabled patients to receive cutting-edge therapies far sooner than would ordinarily be possible.
DARS-NIC-210151-K9C7G-v2.2 19 December 2019 to 5 December 2020
- Title
- HES data for IQVIA clinical trial site identification
- Commercial
- Yes
- Sublicensing
- No
- Datasets
- 3
- Files released
- 0
Datasets: Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Outpatients (HES OP)
What changed from DARS-NIC-210151-K9C7G-v1.2
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2019-12-19 |
Data controllers: + IQVIA LTD
Objective for processing
[1 paragraph unchanged]
IQVIA is a business comprised of a number of legal entities which provide technology and services to healthcare.
This agreement is a request for psuedonymised record-level HES data which will be controlled by two legal entities: IQVIA Solutions UK Limited and IQVIA Technology Services Ltd. Hereafter, these two entities will be referred to collectively as IQVIA.
This agreement is a request to amend the agreement currently in place for psuedonymised record-level HES data to include an additional data controller IQVIA Ltd. The IQVIA UK group is consolidating the majority of its UK business within IQVIA Ltd. IQVIA will be transferring the business and assets (including contracts) of IQVIA
Solutions UK Limited into IQVIA Ltd. Throughout this agreement IQVIA Solutions UK Limited, IQVIA Ltd and IQVIA Technology Services Ltd. will be referred to collectively as IQVIA.
[42 paragraphs unchanged]
Processing activities
[10 paragraphs unchanged] Relevant Extracts of HES data will be used by employees of IQVIA or its Affiliates (noting that Affiliates will only have access to data that has been aggregated with small numbers suppressed in line with the HES analysis guide), for CTSI Analysis to identify hospitals with suitable patient populations for clinical [85 words unchanged] eventually help to make new treatments for diabetes available in the NHS. [13 paragraphs unchanged]
Unchanged: Expected output, Expected measurable benefits, Benefits reported.
Objective for processing
About IQVIA
IQVIA is a business comprised of a number of legal entities which provide technology and services to healthcare.
This agreement is a request to amend the agreement currently in place for psuedonymised record-level HES data to include an additional data controller IQVIA Ltd. The IQVIA UK group is consolidating the majority of its UK business within IQVIA Ltd. IQVIA will be transferring the business and assets (including contracts) of IQVIA
Solutions UK Limited into IQVIA Ltd. Throughout this agreement IQVIA Solutions UK Limited, IQVIA Ltd and IQVIA Technology Services Ltd. will be referred to collectively as IQVIA.
The services to which this agreement relates are to be provided by IQVIA and any companies that are part of the same group of companies as IQVIA anywhere in the world (an ”Affiliate”).
Affiliates are not clients. Affiliates are companies that are part of the same group of companies as IQVIA, and so the clients of affiliates are the clients of IQVIA. Clients are companies external to IQVIA.
The Legal basis for processing of personal data relating to patient health is under Article 9(2)(j)of the GDPR - Processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. The data subjects’ interests and fundamental rights are protected through appropriate minimisation of fields; protection of the data in a secure environment and guaranteeing secure destruction at any stage at the request of NHS Digital or after a defined period on completion of the project.
IQVIA are processing the data in line with their goals as part of their legitimate interests. This is covered under the GDPR Article 6(1)(f) - This work is necessary for the purposes of the legitimate interests pursued by the controller except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child. As set out in the legitimate interest assessment - the data requested is to help achieve the following examples:
Care Pathway Analysis,
Hospital Feedback services,
Benchmarking,
Diagnostic algorithm development studies,
Epidemiology studies,
Health economics and outcomes research studies,
Trust data quality reviews,
Clinical trial analysis.
IQVIA already has a Data Sharing Agreement (DSA) for psuedonymised record-level HES data (DARS-NIC-373563) (the “Existing DSA”) pursuant to which IQVIA is permitted to use HES data via one or more appropriate software applications. The software application is used to display HES data, with data aggregated and small number suppressed in line with the HES analysis guide and is controlled and auditable. Users are given role-based access to these applications, which allow users to perform analyses on aggregated HES data and data from other sources and then view graphs and tables. The analyses may be stratified by diagnosis, organisation and other parameters. The purpose of this DSA which is independent of the Existing DSA (DARS-NIC-373563), is a request for IQVIA and its Affiliates to use any such appropriate software application (an “Appropriate Software Tool”), in order to provide a further permitted service, (bespoke aggregations with small numbers suppressed in line with the HES analysis guide based on the record-level data provided) as described below.
Clinical Trial Site Identification services
IQVIA and its Affiliates will use the HES data via an Appropriate Software Tool to perform Clinical Trial Site Identification Services (CTSI). Affiliates will only access the HES data where it is aggregated with small numbers suppressed in line with the HES analysis guide. CTSI consists of the production of lists of hospital sites with estimates of the size of the patient population at those sites, and lists of physicians affiliated with those sites (by cross-referencing site names and site NACS codes against internal IQVIA group of companies data sources); identification of the presence of referral networks ʹdata on patients being transferred between sites; and visualisation of the above analyses, e.g. heat maps to show patient density. The purpose of these analyses is to determine whether clinical trials are feasible based on site and patient availability and to advise external clients of the above. Examples of IQVIA group of companies’ clients are described below.
Note that, for the purpose of CTSI services, IQVIA and its Affiliates will only use HES data that has been aggregated and small number suppressed through the use of an Appropriate Software Tool.
IQVIA’s Clients
CTSI services will only be provided to the following types of organisations:
• Life sciences industry, such as
o Clinical research organisations (CROs)
o Pharmaceutical companies
o Medical device companies
• Providers of healthcare services, such as
o Clinical Commissioning Groups
o Commissioning Support Units (CSUs)
o Hospital Trusts
o Private secondary care providers
o Mental Health trusts
o Community Provider Trusts
o Pharmacies
o NHS England
o Public Health England
• Universities
• Life sciences industry associations such as the Association of the British Pharmaceutical Industry (ABPI)
Examples of life sciences industry organisations include large pharmaceutical companies engaged in research and development of new medicines.
The specific organisations and the number of organisations to whom IQVIA and its Affiliates provide products and services changes regularly as the global healthcare market is dynamic: the products, therapies and services required by healthcare providers change over time, as do the suppliers of these products, therapies and services.
Third parties to whom IQVIA and its Affiliates shall provide CTSI analyses and results will only see aggregated and small number suppressed data. Data will not be provided in record level form to any third party. IQVIA understands the importance of data minimisation. IQVIA and affiliates will not use outputs for commercial/marketing purposes.
IQVIA’s Requirements of HES Data
The following paragraphs outline IQVIA's and its Affiliates’ requirement for national, timely HES data covering several years for the purposes of CTSI.
• IQVIA require national (UK) data to analyse estimated patient populations at all hospitals in the UK and compare these with similar estimates of patient populations in other countries in which IQVIA and its Affiliates undertake CTSI (using data sources specific to those countries). This information helps clients of IQVIA and its Affiliates to select suitable countries in which to recruit patients into clinical trials, in order to develop new medicines and treatments for patients.
• IQVIA require timely data because the clients to whom IQVIA and its Affiliates provide CTSI analyses and results need to make decisions based on the most up-to-date information. Clients of IQVIA and its Affiliates are often interested in patient populations who have been treated with medicines or treatments that are new to the healthcare market and whose utilisation will only be measurable in the most up-to-date HES data. This information can help clients of IQVIA and its Affiliates decide how best to develop cheaper competing medicines and treatments and bring them to market, which in turn can reduce the cost to healthcare providers and the NHS of providing patient care.
• IQVIA require historic data to enable CTSI analyses to provide insight into changes in patient populations over time. Clients of IQVIA and its Affiliates are often interested in how patient populations are treated in different ways as new medicines and treatments become available, making certain categories of patients more or less frequent over time. In addition, clinical trials are often conducted over long periods of time (often a number of years). Historic data provides more accurate estimates of the size of patient populations at hospitals over a multi-year period than extrapolations from more recent data covering a shorter period.
Expected output
As stated under “Processing Activities", Relevant Extracts from an Appropriate Software Tool will be used for CTSI, the outputs of which shall consist of a list of hospital sites with estimates of the size of the patient population at those sites, a list of physicians affiliated with those sites (based on IQVIA group internal physician data), and visualisations of the CTSI Analysis; all of these outputs together shall comprise the “CTSI Outputs". The CTSI Outputs shall be produced to meet the previously stated purpose. Outputs will only contain aggregate level data with small numbers suppressed in line with the HES analysis guide, or estimates of patient numbers that are based on such aggregated and small number suppressed data.
CTSI Outputs shall occasionally be reported in journal articles or conference presentations. Examples of relevant industry conferences where CTSI Outputs may be reported include the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Drug Information Association (DIA) conferences.
Benefits reported
Clinical trials are often multi-year projects for which results are only available at the end of the research study. As such, it is too early to gauge the full impact of HES data on the trials that have been supported over the last year. This issue is compounded by many initial steps that are required even before running a trial, such as planning, protocol reviews, site selection, start-up and enrolment. However, as of September 30th 2019, IQVIA is currently running 13 ongoing trials that have used HES data; 7 are in the planning/start-up phase and 6 are enrolling patients. Of these trials, three are in rare diseases, two in oncology, and 14 patients have been enrolled. Without access to this data, it would not have been possible to enrol these patients into clinical trials in these difficult-to-treat and difficult-to-identify diseases. This has also enabled patients to receive cutting-edge therapies far sooner than would ordinarily be possible.
DARS-NIC-210151-K9C7G-v1.2 6 December 2019 to 5 December 2020
- Title
- HES data for IQVIA clinical trial site identification
- Commercial
- Yes
- Sublicensing
- No
- Datasets
- 3
- Files released
- 0
Datasets: Hospital Episode Statistics Accident and Emergency (HES A and E); Hospital Episode Statistics Admitted Patient Care (HES APC); Hospital Episode Statistics Outpatients (HES OP)
Objective for processing
About IQVIA
IQVIA is a business comprised of a number of legal entities which provide technology and services to healthcare. This agreement is a request for psuedonymised record-level HES data which will be controlled by two legal entities: IQVIA Solutions UK Limited and IQVIA Technology Services Ltd. Hereafter, these two entities will be referred to collectively as IQVIA.
The services to which this agreement relates are to be provided by IQVIA and any companies that are part of the same group of companies as IQVIA anywhere in the world (an ”Affiliate”).
Affiliates are not clients. Affiliates are companies that are part of the same group of companies as IQVIA, and so the clients of affiliates are the clients of IQVIA. Clients are companies external to IQVIA.
The Legal basis for processing of personal data relating to patient health is under Article 9(2)(j)of the GDPR - Processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. The data subjects’ interests and fundamental rights are protected through appropriate minimisation of fields; protection of the data in a secure environment and guaranteeing secure destruction at any stage at the request of NHS Digital or after a defined period on completion of the project.
IQVIA are processing the data in line with their goals as part of their legitimate interests. This is covered under the GDPR Article 6(1)(f) - This work is necessary for the purposes of the legitimate interests pursued by the controller except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child. As set out in the legitimate interest assessment - the data requested is to help achieve the following examples:
Care Pathway Analysis,
Hospital Feedback services,
Benchmarking,
Diagnostic algorithm development studies,
Epidemiology studies,
Health economics and outcomes research studies,
Trust data quality reviews,
Clinical trial analysis.
IQVIA already has a Data Sharing Agreement (DSA) for psuedonymised record-level HES data (DARS-NIC-373563) (the “Existing DSA”) pursuant to which IQVIA is permitted to use HES data via one or more appropriate software applications. The software application is used to display HES data, with data aggregated and small number suppressed in line with the HES analysis guide and is controlled and auditable. Users are given role-based access to these applications, which allow users to perform analyses on aggregated HES data and data from other sources and then view graphs and tables. The analyses may be stratified by diagnosis, organisation and other parameters. The purpose of this DSA which is independent of the Existing DSA (DARS-NIC-373563), is a request for IQVIA and its Affiliates to use any such appropriate software application (an “Appropriate Software Tool”), in order to provide a further permitted service, (bespoke aggregations with small numbers suppressed in line with the HES analysis guide based on the record-level data provided) as described below.
Clinical Trial Site Identification services
IQVIA and its Affiliates will use the HES data via an Appropriate Software Tool to perform Clinical Trial Site Identification Services (CTSI). Affiliates will only access the HES data where it is aggregated with small numbers suppressed in line with the HES analysis guide. CTSI consists of the production of lists of hospital sites with estimates of the size of the patient population at those sites, and lists of physicians affiliated with those sites (by cross-referencing site names and site NACS codes against internal IQVIA group of companies data sources); identification of the presence of referral networks ʹdata on patients being transferred between sites; and visualisation of the above analyses, e.g. heat maps to show patient density. The purpose of these analyses is to determine whether clinical trials are feasible based on site and patient availability and to advise external clients of the above. Examples of IQVIA group of companies’ clients are described below.
Note that, for the purpose of CTSI services, IQVIA and its Affiliates will only use HES data that has been aggregated and small number suppressed through the use of an Appropriate Software Tool.
IQVIA’s Clients
CTSI services will only be provided to the following types of organisations:
• Life sciences industry, such as
o Clinical research organisations (CROs)
o Pharmaceutical companies
o Medical device companies
• Providers of healthcare services, such as
o Clinical Commissioning Groups
o Commissioning Support Units (CSUs)
o Hospital Trusts
o Private secondary care providers
o Mental Health trusts
o Community Provider Trusts
o Pharmacies
o NHS England
o Public Health England
• Universities
• Life sciences industry associations such as the Association of the British Pharmaceutical Industry (ABPI)
Examples of life sciences industry organisations include large pharmaceutical companies engaged in research and development of new medicines.
The specific organisations and the number of organisations to whom IQVIA and its Affiliates provide products and services changes regularly as the global healthcare market is dynamic: the products, therapies and services required by healthcare providers change over time, as do the suppliers of these products, therapies and services.
Third parties to whom IQVIA and its Affiliates shall provide CTSI analyses and results will only see aggregated and small number suppressed data. Data will not be provided in record level form to any third party. IQVIA understands the importance of data minimisation. IQVIA and affiliates will not use outputs for commercial/marketing purposes.
IQVIA’s Requirements of HES Data
The following paragraphs outline IQVIA's and its Affiliates’ requirement for national, timely HES data covering several years for the purposes of CTSI.
• IQVIA require national (UK) data to analyse estimated patient populations at all hospitals in the UK and compare these with similar estimates of patient populations in other countries in which IQVIA and its Affiliates undertake CTSI (using data sources specific to those countries). This information helps clients of IQVIA and its Affiliates to select suitable countries in which to recruit patients into clinical trials, in order to develop new medicines and treatments for patients.
• IQVIA require timely data because the clients to whom IQVIA and its Affiliates provide CTSI analyses and results need to make decisions based on the most up-to-date information. Clients of IQVIA and its Affiliates are often interested in patient populations who have been treated with medicines or treatments that are new to the healthcare market and whose utilisation will only be measurable in the most up-to-date HES data. This information can help clients of IQVIA and its Affiliates decide how best to develop cheaper competing medicines and treatments and bring them to market, which in turn can reduce the cost to healthcare providers and the NHS of providing patient care.
• IQVIA require historic data to enable CTSI analyses to provide insight into changes in patient populations over time. Clients of IQVIA and its Affiliates are often interested in how patient populations are treated in different ways as new medicines and treatments become available, making certain categories of patients more or less frequent over time. In addition, clinical trials are often conducted over long periods of time (often a number of years). Historic data provides more accurate estimates of the size of patient populations at hospitals over a multi-year period than extrapolations from more recent data covering a shorter period.
Expected output
As stated under “Processing Activities", Relevant Extracts from an Appropriate Software Tool will be used for CTSI, the outputs of which shall consist of a list of hospital sites with estimates of the size of the patient population at those sites, a list of physicians affiliated with those sites (based on IQVIA group internal physician data), and visualisations of the CTSI Analysis; all of these outputs together shall comprise the “CTSI Outputs". The CTSI Outputs shall be produced to meet the previously stated purpose. Outputs will only contain aggregate level data with small numbers suppressed in line with the HES analysis guide, or estimates of patient numbers that are based on such aggregated and small number suppressed data.
CTSI Outputs shall occasionally be reported in journal articles or conference presentations. Examples of relevant industry conferences where CTSI Outputs may be reported include the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Drug Information Association (DIA) conferences.
Benefits reported
Clinical trials are often multi-year projects for which results are only available at the end of the research study. As such, it is too early to gauge the full impact of HES data on the trials that have been supported over the last year. This issue is compounded by many initial steps that are required even before running a trial, such as planning, protocol reviews, site selection, start-up and enrolment. However, as of September 30th 2019, IQVIA is currently running 13 ongoing trials that have used HES data; 7 are in the planning/start-up phase and 6 are enrolling patients. Of these trials, three are in rare diseases, two in oncology, and 14 patients have been enrolled. Without access to this data, it would not have been possible to enrol these patients into clinical trials in these difficult-to-treat and difficult-to-identify diseases. This has also enabled patients to receive cutting-edge therapies far sooner than would ordinarily be possible.
Register history
When this agreement appeared in, or was edited in, each monthly edition of the register. Built by comparing every edition this site holds, the earliest of which is July 2021.
-
July 2021 —
already listed in the earliest edition this site holds, so it may be older. 3 versions: DARS-NIC-210151-K9C7G-v1.2, DARS-NIC-210151-K9C7G-v2.2, DARS-NIC-210151-K9C7G-v3.3
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March 2022
1 version added: DARS-NIC-210151-K9C7G-v4.3
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December 2022
Register-wide edit DARS-NIC-210151-K9C7G-v1.2, DARS-NIC-210151-K9C7G-v2.2 — Datasets: legal basis: “
s261(1) and” taken out. Made to 639 agreements in this edition, so it is reported once, on the changes page, and not counted as an amendment of this agreement. -
March 2024
1 version added: DARS-NIC-210151-K9C7G-v5.2
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January 2025
1 version added: DARS-NIC-210151-K9C7G-v6.2
Cite this page
NHS England (2026) Data Uses Register, September 2026 edition, agreement DARS-NIC-210151-K9C7G, “HES data for IQVIA clinical trial site identification”. Read via NHS Data Access Explorer (unofficial), https://healthdatauses.uk/agreements/dars-nic-210151-k9c7g/ (accessed [date]).
This address stays the same, but the page is rebuilt with each monthly edition, so the citation names the edition it shows. Every edition's data is kept in the facts store.
Source: datausesregister_september2026.xlsx, September 2026 edition of the NHS England Data Uses Register. Search that workbook for DARS-NIC-210151-K9C7G to see the original rows.