INvestigation of TRELEGY Effectiveness: Usual PractIce Design (INTREPID) Exploratory data set

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Objective for processing

GlaxoSmithKline Research & Development Limited (GSK) requires access to NHS Digital Hospital Episode Statistics (HES) England data for the purpose of an exploratory outcome for the Phase 4 study entitled “INTREPID: ‘INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design". PractIce Design’ [1 paragraph unchanged] In this study’s exploratory outcome, the focus is on Healthcare healthcare resource utilisations utilisation (HCRU) data in several countries including England. The General Data Protection Regulation (GDPR) states that GSK must have a legal basis in law in order to process sensitive data. Article 6 (1) (f) Legitimate interests is cited by GSK since GSK are a Pharmaceutical Company carrying out medical research which is of benefit to science and public health, as described in this Agreement. To determine the lawfulness of processing the data for these legitimate interests, GSK has undertaken a Legitimate Interests Assessment (LIA) and determined that: i. The processing is necessary for the purpose: The data being requested from NHS Digital that GSK need to process will allow GSK to achieve the stated purpose/objectives: - First objective: to assess the feasibility of using routine healthcare data to collect secondary care healthcare resource utilisation data (all cause and COPD related) in clinical trials using HES data for patients consented into the INTREPID study. GSK will describe the recording (available in HES, yes/no) and completeness (% non-missing values) of different components of secondary care HCRU and the ability to apply Healthcare Resource Group (HRG) tariffs to these where possible. - Second Objective: to use the HES data to summarise HCRU and costs using HRG tariffs for COPD patients (all cause and COPD related) on inhaled triple therapy for patients consented into the INTREPID study. Without the data being requested it would not be possible to perform the analysis to gain the required outcomes stated. ii. The processing is proportionate to the purpose: Only specific data variables for the recruited cohort are being requested and used in the way outlined to each individual patient in the informed consent form. This will ensure there is minimal privacy impact and the processing is proportionate. iii. The purpose cannot be achieved by processing the data in another more obvious or less intrusive way. There is little impact on the data subjects since this data being sourced from NHS Digital will be compared with similar data collected at the site from patient interview. There will be no negative direct impacts on individuals whose data is processed. No patient is likely to object or find the processing intrusive as each has provided explicit informed consent. Patients wishing to object can do so by contacting GSK’s data privacy officer or through the investigational site. iv. The interests of the individual data subjects do not override the legitimate interest: There was no previous direct relationship with any individual in the study prior to their recruitment. The requirement to source the data being requested from NHS Digital was made clear to each patient during enrolment and as part of the Informed Consent literature. GSK are responding to an industry wide interest in utilising real world data to provide better insight into medicines development. This is primarily a methodological study. GSK has a legitimate interest in innovative methodologies for pragmatic clinical trials. One of the areas of interest is “digitally enabled trials”. The current methodological study seeks to investigate whether routine data provided by organisations such as NHS Digital could be used as a means of data collection of outcomes for pragmatic real world clinical trials in England. In the context of pragmatic real world clinical trials, use of routine data to collect outcomes has the potential to be a more effective and efficient way of collecting data compared to case report forms (CRFs) thereby reducing burden on local clinical investigators (for example GPs who have agreed to recruit patients) and allow better ascertainment of outcomes which are important to patients, physicians, and payer organisations such as the NHS. To this end, an exploratory objective of the INTREPID trial (a GSK sponsored real world trial of the effectiveness of fluticasone furoate/umeclidinium/vilanterol vs multiple inhaler triple therapy in chronic obstructive pulmonary disease (COPD)) was to assess the validity of routine health care resource utilisation (HCRU) data for patients who were included in INTREPID and consented to data linkage. In the case of patients from England, GSK aim to assess the validity of HCRU collected via HES. Secondary care attendance for COPD (in particular COPD hospitalisation [severe COPD exacerbation]) was selected as a use case in particular is an important endpoint for patients, physicians and the NHS. In addition, use of routine data (such as HES) is an ideal methodological use case for HCRU ascertainment as it should in theory provide complete coverage of secondary care contacts for patients in England. Internally, GSK will use the findings to inform potential future real world trial design using ascertainment of HCRU via routine data. GSK's interests are shared with the wider health data research and clinical development community within the UK, and as well as sharing outputs internally, GSK intend to communicate their findings and experiences via abstracts to conferences, manuscripts in the peer reviewed literature, and collaborations such as HDR-UK BREATHE (https://www.hdruk.ac.uk/helping-with-health-data/health-data-research-hubs/breathe/). Trelegy ELLIPTA is an inhaled therapy for people with chronic obstructive pulmonary disease (COPD) which is a chronic lung condition associated with shortness of breath, coughing and wheezing. There are a wide range of drugs that are available for the treatment of COPD in the UK. The most severe patients who experience “flare-ups” in their symptoms (called exacerbations) are usually given a combination of three different drugs. Trelegy ELLIPTA provides these three drugs in a single inhaler, and as such, the Article 1 (f) legal basis for data processing, legitimate interests, applies. As special category data, the data is further being processed under article 9(2)(j) (processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes). This is because the consented data will be used to enhance the potential outcomes and improve care, which is in the public interest. All patients have been fully informed of the data processing and the organisations carrying out the data processing. Each individual has provided explicit informed consent. The research provides wider public benefit and the risks to the individuals are low. Healthcare resource utilisations (HCRU) is the quantifiable measure of a person’s use of services for the purpose of both preventing and curing health problems, the promotion of maintenance of health and wellbeing. Through systematic review, the disease burden experienced by the patient and associated healthcare can be assessed. [1 paragraph unchanged] First objective: to assess the feasibility of using routine healthcare data to collect secondary care healthcare resource utilisation data (all cause (all-cause and COPD Chronic obstructive pulmonary disease (COPD) related) in clinical trials using HES Hospital Episode Statistics (HES) data for patients who consented into to the INTREPID study. The study will describe the recording (available in HES, [15 words unchanged] ability to apply Healthcare Resource Group (HRG) tariffs to these where possible. Second Objective: to use the HES data to summarise HCRU and costs using HRG tariffs for COPD patients (all cause (all-cause and COPD related) on inhaled triple therapy for patients who consented into to the INTREPID study. (HRG is analysed using the latest publicly available National Cost Collection: https://improvement.nhs.uk/resources/national-cost-collection/) This is primarily a methodological study. GSK has a legitimate interest in innovative methodologies for pragmatic clinical trials. One of the areas of interest is “digitally enabled trials”. The current methodological study seeks to investigate whether routine data provided by organisations such as NHS England could be used as a means of data collection of outcomes for pragmatic real-world clinical trials in England. In the context of pragmatic real-world clinical trials, use of routine data to collect outcomes has the potential to be a more effective and efficient way of collecting data compared to case report forms (CRFs) thereby reducing the burden on local clinical investigators (for example GPs who have agreed to recruit patients) and allow better ascertainment of outcomes which are important to patients, physicians, and payer organisations such as the NHS. All-cause HCRU is an overall summary measure of HCRU. For example, this might be expressed as overall number of hospital admissions during follow up for any cause, or overall number of days in hospital during a year. Looking at all-cause HCRU will give a fuller picture of HCRU. Summarising all-cause HCRU will, for example, allow investigation into whether a reduction in COPD HCRU associated with treatment translates to a reduction in HCRU at the all cause level. Importantly, individual causes will not be analysed or reported – this is an overall measure of any HCRU. This is a standard and expected outcome for HCRU analysis of this kind and is required to meet the scientific objectives of the study. To this end, an exploratory objective of the INTREPID trial (a GSK sponsored real-world trial of the effectiveness of fluticasone furoate/umeclidinium/vilanterol vs multiple inhaler triple therapy in COPD) was to assess the validity of routine HCRU data for patients who were included in INTREPID and consented to data linkage. In the case of patients from England, GSK aims to assess the validity of HCRU collected via HES. This study will consider the following HCRU and cost outcomes (all cause and COPD related): The following NHS England data will be accessed: • Secondary care outpatient attendance Hospital Episode Statistics • Hospital admission o Admitted Patient Care • ICU admission during hospital admission o Accident & Emergency • A&E attendance o Critical Care • Secondary care costs o Outpatients The highly controlled conditions of a randomised clinical trial (RCT) remove factors that influence and differentiate the use of medicines in everyday clinical practice. Effectiveness data generated in the broader population observed in an everyday clinical setting is increasingly being recognised as important in complementing data derived from the pivotal Phase III safety and efficacy studies. The data requested will enhance the analysis of Healthcare Resource Utilisation by supplementing what is in the patient’s primary care records and what can be feasibly collected via electronic Case Report Forms (eCRFs. Furthermore, access to HES data helps GSK develop a better understanding of A&E attendance related to acute exacerbations of COPD. The primary purpose of the wider study is to assess the effectiveness of TRELEGY ELLIPTA relative to non-ELLIPTA Multiple Inhaler Triple Therapies (MITT) for Chronic Obstructive Pulmonary Disease (COPD) control within the usual clinical practice setting. This study was conducted once TRELEGY ELLIPTA had been approved and is available commercially. The level of the data will be: Primary care Electronic Medical Records (EMR) do not accurately and reliably capture complete information about hospital attendances and admissions. Therefore, to assess the full spectrum of healthcare resource utilisation by individual patients consented into the INTREPID study, additional information is required. The data requested will enable research to be carried out to better understand the service impact on the National Health Service (NHS) for patients; some examples have been provided below: • Pseudonymised • A better understanding of A&E attendances relating to acute exacerbations of COPD. Data was previously disseminated under consent and contained confidential patient identifiable data. However, as the identifiers are no longer retained, the level of data is now classified as Pseudonymised • Understanding which admissions represent serious events. The data will be minimised as follows: By understanding the above the data will enhance the understanding of a patient’s experience of the study drug by providing additional information, not readily available elsewhere, on their health during the trial period. • Limited to a study cohort identified by GSK – 629 participants of the INTREPID trial. In addition, primary and available secondary healthcare resource utilisation data including prescriptions associated with COPD and related medical conditions will be collected in the electronic Case Report Form (eCRF) by the investigator and study-site personnel for all participants and combined with the Hospital Episode Statistics (HES) datasets being applied for in this Agreement. Visits and contacts that are due to a moderate or severe COPD exacerbation will be assessed and recorded. • Limited to data between 2017/18- 2019/20 The data collected within the eCRF for the wider study will include: GSK is the sponsor for the INTREPID Study and controller as the organisation responsible for ensuring that the data will only be processed for the purposes described above. • Primary healthcare contacts The lawful basis for processing personal data under the UK GDPR is: • Medications Article 6(1)(f) - processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party. • Hospital admissions, outpatient appointments and A&E attendances GSK has determined the processing is necessary for its legitimate interests. GSK are a Pharmaceutical Company carrying out medical research which is of benefit to science and public health, as described in this Data Sharing Agreement (DSA). To determine the lawfulness of processing the data for these legitimate interests, GSK undertook a Legitimate Interest Assessment (LIA). GSK has minimised the data collected by focusing on HCRU data for only those patients who were included in the INTREPID trial and who consented to data linkage to NHS Digital Data. This is a small cohort of patients. The number of current participants in England is 629. The original total possible subject pool for this application in England was 835. After the consenting process, this number was reduced to 702. A further 73 were removed due to the GP practices involved not providing linkage information to Ignite Data to provide to NHS Digital. This left a total subject pool of 629 for linkage. Data is only collected for these 629 individuals. The lawful basis for processing special category data under the UK GDPR is: GSK also reviewed the data specifications with the case officer and advisors from NHS digital in order to update the original specifications due to changes in the NHS datasets. Any obsolete data (data not absolutely necessary to achieve the scientific objectives of the study,) was omitted from the final request. Article 9(2)(j) - 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. GSK also limited the years of data requested since the interest is only in data from patients covering the lifetime of the study. Patients were recruited into the study between early 2018 and late 2019, hence only the 3 years of data to cover this period of patient participation has been requested. This is the minimum time period necessary to achieve the scientific objectives of the study. This processing is in the public interest because the consented data will be used to enhance the potential outcomes and improve care, which is in the public interest. GSK have requested data for all patients in the INTREPID trial in England, who consented to data linkage to HES. These patients may have been spread throughout England. As GSK wish to utilise centralised secondary care healthcare data from specific English patients, approaching NHS Digital to use their data was the only reasonable way to achieve GSK's objectives. GASK have only requested the minimum variables required to conduct the analysis. There are not less intrusive ways of achieving the purpose. The objective is to explore the use of linked routine data such as HES to ascertain HCRU. This by definition requires linkage to HES. The funding is provided by GSK. The funding is specifically for the INTREPID Study described. Organisations involved: Data will be accessed by substantive employees of GSK. • GlaxoSmithKline (GSK): The sponsor for the INTREPID study. GSK received the final pseudonymised cut of study data, including HES data provided by NHS Digital. GSK are both a data controller and processor for this study. GSK funds the study and is also the manufacturer of the device being studied and therefore may potentially receive a commercial benefit. However, the research is focused on wider service improvement. • Ignite Data (IGNITE): IGNITE had the explicit consent of participants for receiving their HES data linked to their unique study ID for processing the data on GSK’s behalf and pseudonymisation prior to delivery for research. IGNITE previously had access to the record level data to complete this work and this is made clear to the participants in the study information sheet and Informed Consent Form (ICF) the participants complete. IGNITE has since destroyed the data as their involvement in data processing has been completed. IGNITE no longer have any access to the data disseminated under this Agreement. For this reason, IGNITE are no longer considered a Data Processor. A commercial aspect of this request relates to the commercial relationship between GlaxoSmithKline (GSK) and Ignite Data Limited. GSK previously commissioned Ignite Data Limited to perform the initial processing of the data described in section 5b – Processing Activities for the purpose of this research. Ignite Data Limited only performed the processing of NHS England (was NHS Digital) data described under previous iterations of this Agreement. The Randomised Clinical Trial (RCT) outlined in this request is not associated with any other commercial aspect, including products and services provided by GSK. The cohort was recruited to the main randomised controlled trial (RCT) element of the study. Each patient has a current diagnosis of Chronic obstructive pulmonary disease (COPD) and was eligible for a triple therapy treatment. Each individual patient was recruited via the study site, which for the most part was their local GP. The GP Practices were selected from across the country. In a small number of cases the patient may have been referred from another local GP Practice or referred to an alternative local site (e.g., a hospital). Each patient in the cohort was then consented and managed by this local study site. The RCT data was then collected at a series of standard study visits at the patient’s specific study site. GSK are funding this research with commercial revenues. However, all patients provided explicit consent for this research to be carried out and all outcomes will be published. GSK are requesting continued access to record-level identifiable data from the following Hospital Episode Statistics (HES) datasets: • HES Admitted Patient Care • HES Accident and Emergency • HES Critical Care • HES Outpatients The data requested will enhance the analysis of Healthcare Resource Utilisation by supplementing what has been located in the patient’s primary care records and what can be feasibly collected via eCRFs. As detailed above, this will enable research into the primary and secondary objectives. The application is commercially funded by GSK. The data is only being used for the purposes stated above. GSK has a corporate policy to publish results of all research, regardless of whether they reflect positively or negatively on their medicines. https://www.gsk.com/en-gb/research-and-development/trials-in-people/data-transparency/ [1 paragraph unchanged] The patient ICF makes reference to this specific healthcare resource utilisation work in the ‘Use of National Healthcare Data’ section. The study is predominantly focused on understanding the reduction service use and cost for greater public benefit. Trelegy and Ellipta are registered trademarks of the GlaxoSmithKline group of companies. The medicine was approved for use as a maintenance treatment in adult patients with moderate to severe COPD by the US Food and Drug Administration (FDA) in September 2017 and marketing authorisation valid throughout the European Union was approved by the European Medicines Agency (EMA) in November 2017. The official Marketing authorisation holder in Europe is listed as GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. Trelegy Ellipta is manufactured by Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) at GSK’s Ware facility: Priory Street, Ware, Hertfordshire SG12 0DJ UK.

Processing activities

GSK requested access to the data under the data flows described below: IGNITE was listed as a Processor in previous iterations of this DSA. The role of IGNITE, as described below, has been completed. IGNITE has destroyed all copies of the Data previously received from NHS England and as such, no longer has any access to the Data nor any continued involvement in the study. As such, IGNITE is no longer a Processor. 1. Participating practises collected consent from patients using ICF and collect patient identifiers including NHS Number, First Name, Surname, Date of Birth and Postcode. IGNITE transferred data to NHS England. The data consisted of identifying details specifically NHS Number, Study ID, Date of Birth, Postcode, first name and surname for the cohort to be linked with NHS England data. 2. Practises transferred copies of completed ICFs and file containing patient identifiers to IGNITE via password protected email. IGNITE stored ICFs and patient data using Cloud Storage provided by Microsoft Azure. For this reason Microsoft Azure were previously included as a Data Processor and the appropriate data centre locations were included. NHS England provided the relevant records from the HES datasets to IGNITE. The Data: 3. IGNITE then applied a unique Study ID to each participant to form a Subject Log of all participants and associated identifiers. • contained no direct identifying data items but contained a unique person ID which was used to link the Data with other record level data already held by the recipient. NHS England Data was linked to pseudonymised clinical data at IGNITE prior to being disseminated to GSK. 4. IGNITE submitted Subject Log containing all cohort data including identifiers to NHS Digital for linkage to HES datasets. IGNITE linked NHS England Data to pseudonymised clinical trial data using Study ID. 5. NHS Digital provided HES data for all 835 initial cohort members to IGNITE via Secure Electronic File Transfer (SEFT). This data was received by IGNITE and stored on Cloud Storage provided by Microsoft Azure. IGNITE removed all patients’ identifiers except for Study ID. 6. IGNITE linked NHS Digital data to pseudonymised clinical trial data using Study ID. IGNITE removed all patients’ identifiers except for Study ID. IGNITE transferred the linked, pseudonymised dataset to GSK. 7. IGNITE transferred the linked, pseudonymised dataset to GSK for analysis where: Under this DSA, IGNITE no longer play a role and all data (including NHS England Data IGNITE received) has since been destroyed. a. The data will be processed to produce descriptive statistics on the patient cohort. Initially, the feasibility of assessing each component of healthcare resource utilisation HCRU will be assessed by tabulating missingness of key variables. Where variables have a low degree of missingness the team will summarise HCRU using means, medians and proportions as appropriate both for COPD related and all cause HCRU. For example, frequency and mean length of stay in hospital for COPD related and all-cause in-patient hospitalisations to understand admitted patient care; average frequency of respiratory related emergency department attendance to better understand COPD exacerbations resulting in A&E attendance; and average frequency of attendance at outpatient clinics to better understand the use of secondary care services in this patient group. The team will summarise HCRU overall and by important subgroups where there are sufficient numbers. GSK only holds the pseudonymised data. GSK will not link the data to any other data and will only carry out analyses on these data for the purposes described in this DSA. and will not attempt to re-identify individuals during the use of the data. IGNITE were listed as a Data Processor in previous iterations of this Agreement. The role of IGNITE, as described above, has been completed. IGNITE have destroyed all copies of the data previously received from NHS Digital and as such, no longer have any access to the data or any continued involvement in the study. As such, IGNITE are no longer considered a Data Processor. The Data is stored on servers at GSK. Microsoft Azure cloud was being used by IGNITE to store the data they previously held. They supplied support to the system but did not access data. As such, when IGNITE were removed as a Data Processor from this Agreement, so were Microsoft. Microsoft are not considered as a Data Processor going forward. GSK do not use cloud services to store NHS Digital data under this Agreement. The Data will be accessed by authorised GSK personnel who are members of the Trelegy study team. GSK had set up a data storage site and workstation in England that allowed authorised GSK analysts to access and analyse the data remotely in North America, whilst ensuring the data and any analytical output remained in England. This was identified as being incompatible with the intent of the licensing provision of the Framework Agreement, as these analysts were based outside the territory of use permitted in the DSA. GSK has since restricted viewing access to the NHS Digital data to GSK staff based only in England or Wales. The Data will be accessed by authorised personnel via remote access. The Data will remain on the servers at GSK at all times. In this study, directly identifiable personal information is determined to be the Participant Surname, Forename, Date of Birth, NHS Number, Address and Post Code. This data was legitimately required by Ignite to hold for administrative purposes and to pass to NHS Digital for Participant record identification purposes. IGNITE had explicit consent of participants for receiving their HES data linked to their unique study ID for processing the data on GSK’s behalf and pseudonymisation prior to delivery for research. Remote processing will only be through a secure electronic network and technical and organisational controls prohibit personnel from downloading or copying data to local devices. The data has been linked to pseudonymised clinical trial data obtained during a patients’ participation using a code (GSK Study ID). This will enhance the understanding of their Healthcare Resource Utilisation during their study participation. The dataset provided by NHS Digital has been pseudonymised using a study specific identifier by IGNITE prior to sending to GSK for analysis. Remote processing will be subject to the following being in place: IGNITE previously had access to the record level data to complete this work and this has been made clear to the participant in the Patient Information Sheet (PIS) and Informed Consent Form (ICF) the participants have completed. • Multifactor authentication (MFA); GSK is the only organisation involved in this Agreement going forward. At GSK, data access is restricted to specific research teams and is only accessible to members of these teams via role-based access controls to file shares and servers. All members of these teams are substantively employed by GSK. • Access controls granting users the minimum level of access required; The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement. All outputs will be restricted to aggregate data with small numbers suppressed in line with HES Analysis Guide. • Secure connections (e.g., VPNs or secure protocols) to protect data during remote access; NHS Digital reminds all organisations party to this Agreement of the need to 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). • Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls. All remote access is undertaken within the scope of the relevant organisations’ DSPT (or other security arrangements as per this Data Sharing Agreement (DSA)). The Data will not leave England or Wales at any time. Access is restricted within the Trelegy Study Team of the Value Evidence and Outcomes organisation within GSK which has authorisation from the Study Accountable Person or Scientific Lead. All such individuals are substantive employees of GSK. All personnel accessing the data have been appropriately trained in data protection and confidentiality.

Expected output

The wider INTREPID study will produce a study report, which will be published in the public domain. The expected outputs of the processing are: As part of the wider INTREPID study, further submissions to peer reviewed journals, presentations and conferences may be made. At this stage, it is hard to determine the impact of the data processed as part of this application. If anything of significance identified as part of the objectives, these would form part of the wider INTREPID study publications. • An abstract was presented at ISPOR-EU 2022 conference (International Society for Pharmacoeconomics and Outcomes Research Europe 2022) in November 2022. Any published results would contain data which has been minimised and aggregated to ensure privacy is maintained. All data in outputs will be published in-line with GSK policies. • The findings of this will be submitted as a manuscript with publication estimated Quarter #1 2024. The data from NHS Digital outputs will not be used for any other purpose other than that outlined in this Agreement. All outputs contain NHS England data and will be restricted to aggregate data only contain aggregated information with small numbers suppressed as appropriate in line with HES Analysis Guide. the relevant disclosure rules for the dataset(s) from which the information was derived. In accordance with GSK’s internal policy, all trial results will be shared, regardless of whether they reflect positively or negatively on GSKs medicines. GSK posted information about the INTREPID study on a publicly accessible register (ClinicalTrials.Gov - https://clinicaltrials.gov/ct2/show/NCT03467425) before it started and will update it with a result summary after the study is finished. GSK seek the publication of all results of all clinical trials in peer-reviewed scientific journals and the INTREPID study and any relevant result found as part of the data processing activities in this application will be no different. The outputs will be communicated to relevant recipients through the following dissemination channels: The last patient last visit for the INTREPID study was October 2019. The date analysis of the real-world data captured during the study has begun. At present, it is estimated that initial results may be published from early 2022. GSK aim to submit findings to conferences for presentation in 2022 and peer reviewed journals for anticipated publication in 2022/2023. GSK aim to submit to conferences and journals where the findings presented will inform practice and policy. For example, by selecting target conferences and journals with both respiratory clinical as well as a health economics audience. • Peer-reviewed Journals GSK has published policies for sharing outputs on its website, found at : https://www.gsk.com/media/2946/disclosure-of-clinical-trial-information-policy.pdf. • Conferences • Presentations • Study report • Information about the INTREPID study is available on a publicly accessible register (ClinicalTrials.Gov - https://clinicaltrials.gov/ct2/show/NCT03467425) • Engagement with strategic partners for example BREATHE the respiratory hub for HDR-UK • Patient Information leaflets available on the study website

Expected measurable benefits

A full picture of the real-world implications of COPD and its treatment can only be formed when all interactions with the healthcare services can be appraised. It is hoped the results from this study will provide insight into how real-world patients interacted with the UK healthcare system whilst they participated in this study. The dissemination of this information is planned be included into the wider outputs of the INTREPID study, where the objectives are to assess the effectiveness of TRELEGY ELLIPTA relative to non-ELLIPTA Multiple Inhaler Triple Therapies (MITT) for Chronic Obstructive Pulmonary Disease (COPD) control within the usual clinical practice setting. It is hoped that improved understanding of COPD and its treatment will improve patient outcomes and reduce the burden on the UK healthcare service by: An abstract based on the findings from this study was presented at the ISPOR EU 2022 conference in Vienna in November 2022*. • Improving understanding of the workload of healthcare placed on the patient in this population, for example, the frequency of COPD related outpatient visits and how this relates to total frequency of all-cause outpatient visits in patients taking triple inhaled therapy Here GSK presented data to support the conclusions that: • Improving understanding of serious events in this population, such as hospitalisation for acute exacerbation of COPD in patients taking triple inhaled therapy • Linked HCRU data analysed for English patients in the INTREPID trial provided a greater level of detail than that generally available from the prospectively collected patient recall of HCRU in pragmatic studies. Future studies in COPD should consider the benefits of using linked routine hospital data alongside prospectively collected data in pragmatic trials in routine practice in England. • Improving ability to understand if the clinical research community can conduct medical research and answer these types of question more effectively and efficiently in the UK using these types of data. ISPOR Europe is a global scientific congress which covers key health economics and outcomes research topics including: As the second most common reason for emergency medical admission in the UK, COPD represents a substantial cost to the NHS. The datasets provided will be analysed to better understand the healthcare resource utilisation of patients included in this study. It is hoped that the dissemination of this information will expand the understanding of disease burden for patients initiating triple inhaled therapy in the UK. Information on cost and healthcare resource utilisation are used by organisations such as the NHS when making decisions on the organisation and delivery of care. The information generated from this analysis should, for example, provide valuable information on which aspects of secondary care represent the highest use of healthcare resource in this population. This information is valuable to the NHS as it can be used to determine which aspects of secondary care, if targeted could yield the greatest reduction in overall healthcare resource utilisation and costs. Reduction of overall healthcare resource utilisation and costs in one area, for example, reduction in unplanned COPD admissions means that more resources could be spent on another area, for example on preventative healthcare services. • Clinical Outcomes The outputs are integral to the analysis of the Healthcare Resource Utilisation of patients in the study, as they are the most accurate representation of the patient’s interactions with the UK healthcare service. They are also required so that an assessment of data available within pre-existing datasets can be made against that captured within the eCRF. • Economic Evaluation GSK aim to submit to conferences and journals where the findings presented will inform practice and policy, for example, by selecting target conferences and journals with both respiratory clinical as well as a health economics audience. Following the dissemination of these findings (targeted for 2022), GSK also aim to engage with their strategic partners, for example BREATHE, the respiratory hub for HDR UK (the UK’s National Institute for Health Data Science) in order improve the clinical research community’s ability to understand how medical research can be conducted and answer these types of questions more effectively and efficiently in the UK using these types of data (for example, future digitally enabled trials). • Epidemiology and Public Health GSK anticipate that future benefits will follow on from presentations at international conferences and after publications of findings in the peer reviewed literature – i.e., once the findings are disseminated to the wider interested community. GSK aim to submit the findings as an abstract to ISPOR-EU conference due to be held in Nov 2022 and to submit the findings as a manuscript in Q3 2022, and pending journal timelines, GSK estimate publication in Q1 2023. GSK's target date for future benefits is therefore from Q1 2023. • Health Policy and Regulatory • Health Service Delivery and Process of Care • Health Technology Assessment • Medical Technologies • Methodological and Statistical Research • Organisational Practices • Patient-Centered Research • Real-World Data and Information Systems • Real-World Evidence • Study Approaches GSK anticipate that benefits will accrue following scientific engagement with industry, consulting, public sector, and academic scientists and decisions makers at conferences such as ISPOR and following the publication of a manuscript in the peer reviewed literature. * Numbere B, Joksaite S, Gelwicks S, Lu Y, Fry M, Compton C, Ismaila AS, Rothnie KJ. Assessing the Validity of English Linked Routine Healthcare Resource Utilisation Data in the Investigation of Triple Therapy Effectiveness (INTREPID Trial). ISPOR Europe, November 2022.

Benefits reported

No benefits have been yielded to date. Due to delays in receiving the data from NHS Digital, resulting from the pandemic, quality checks of the data prior to analysis are only just being completed. An abstract based on the findings from this study was presented at the ISPOR EU 2022 conference in Vienna in November 2022*. Here GSK presented data to support the conclusions that: • Linked HCRU data analysed for English patients in the INTREPID trial provided a greater level of detail than that generally available from the prospectively collected patient recall of HCRU in pragmatic studies. Future studies in COPD should consider the benefits of using linked routine hospital data alongside prospectively collected data in pragmatic trials in routine practice in England. ISPOR Europe is a global scientific congress which covers key health economics and outcomes research topics including: • Clinical Outcomes • Economic Evaluation • Epidemiology and Public Health • Health Policy and Regulatory • Health Service Delivery and Process of Care • Health Technology Assessment • Medical Technologies • Methodological and Statistical Research • Organizational Practices • Patient-Centered Research • Real-World Data and Information Systems • Real-World Evidence • Study Approaches GSK anticipate that benefits will accrue following scientific engagement with industry, consulting, public sector, and academic scientists and decisions makers at conferences such as ISPOR and following the publication of a manuscript in the peer reviewed literature. * Numbere B, Joksaite S, Gelwicks S, Lu Y, Fry M, Compton C, Ismaila AS, Rothnie KJ. Assessing the Validity of English Linked Routine Healthcare Resource Utilisation Data in the Investigation of Triple Therapy Effectiveness (INTREPID Trial). ISPOR Europe, November 2022.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

GlaxoSmithKline (GSK) requires NHS Digital Hospital Episode Statistics (HES) data for the purpose of an exploratory outcome for the Phase 4 study entitled “INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design". [3 paragraphs unchanged] To determine the lawfulness of processing the data for these legitimate interests, GSK has undertaken a Legitimate Interests Assessment (LIA) and determined that: i. The processing is necessary for the purpose: The data being requested from NHS Digital that GSK need to process will allow GSK to achieve the stated purpose/objectives: - First objective: to assess the feasibility of using routine healthcare data to collect secondary care healthcare resource utilisation data (all cause and COPD related) in clinical trials using HES data for patients consented into the INTREPID study. GSK will describe the recording (available in HES, yes/no) and completeness (% non-missing values) of different components of secondary care HCRU and the ability to apply Healthcare Resource Group (HRG) tariffs to these where possible. - Second Objective: to use the HES data to summarise HCRU and costs using HRG tariffs for COPD patients (all cause and COPD related) on inhaled triple therapy for patients consented into the INTREPID study. Without the data being requested it would not be possible to perform the analysis to gain the required outcomes stated. ii. The processing is proportionate to the purpose: Only specific data variables for the recruited cohort are being requested and used in the way outlined to each individual patient in the informed consent form. This will ensure there is minimal privacy impact and the processing is proportionate. iii. The purpose cannot be achieved by processing the data in another more obvious or less intrusive way. There is little impact on the data subjects since this data being sourced from NHS Digital will be compared with similar data collected at the site from patient interview. There will be no negative direct impacts on individuals whose data is processed. No patient is likely to object or find the processing intrusive as each has provided explicit informed consent. Patients wishing to object can do so by contacting GSK’s data privacy officer or through the investigational site. iv. The interests of the individual data subjects do not override the legitimate interest: There was no previous direct relationship with any individual in the study prior to their recruitment. The requirement to source the data being requested from NHS Digital was made clear to each patient during enrolment and as part of the Informed Consent literature. GSK are responding to an industry wide interest in utilising real world data to provide better insight into medicines development. This is primarily a methodological study. GSK has a legitimate interest in innovative methodologies for pragmatic clinical trials. One of the areas of interest is “digitally enabled trials”. The current methodological study seeks to investigate whether routine data provided by organisations such as NHS Digital could be used as a means of data collection of outcomes for pragmatic real world clinical trials in England. In the context of pragmatic real world clinical trials, use of routine data to collect outcomes has the potential to be a more effective and efficient way of collecting data compared to case report forms (CRFs) thereby reducing burden on local clinical investigators (for example GPs who have agreed to recruit patients) and allow better ascertainment of outcomes which are important to patients, physicians, and payer organisations such as the NHS. To this end, an exploratory objective of the INTREPID trial (a GSK sponsored real world trial of the effectiveness of fluticasone furoate/umeclidinium/vilanterol vs multiple inhaler triple therapy in chronic obstructive pulmonary disease (COPD)) was to assess the validity of routine health care resource utilisation (HCRU) data for patients who were included in INTREPID and consented to data linkage. In the case of patients from England, GSK aim to assess the validity of HCRU collected via HES. Secondary care attendance for COPD (in particular COPD hospitalisation [severe COPD exacerbation]) was selected as a use case in particular is an important endpoint for patients, physicians and the NHS. In addition, use of routine data (such as HES) is an ideal methodological use case for HCRU ascertainment as it should in theory provide complete coverage of secondary care contacts for patients in England. Internally, GSK will use the findings to inform potential future real world trial design using ascertainment of HCRU via routine data. GSK's interests are shared with the wider health data research and clinical development community within the UK, and as well as sharing outputs internally, GSK intend to communicate their findings and experiences via abstracts to conferences, manuscripts in the peer reviewed literature, and collaborations such as HDR-UK BREATHE (https://www.hdruk.ac.uk/helping-with-health-data/health-data-research-hubs/breathe/). Trelegy ELLIPTA is an inhaled therapy for people with chronic obstructive pulmonary disease (COPD) which is a chronic lung condition associated with shortness of breath, coughing and wheezing. There are a wide range of drugs that are available for the treatment of COPD in the UK. The most severe patients who experience “flare-ups” in their symptoms (called exacerbations) are usually given a combination of three different drugs. Trelegy ELLIPTA provides these three drugs in a single inhaler, and as such, the Article 1 (f) legal basis for data processing, legitimate interests, applies. [25 paragraphs unchanged] GSK has minimised the data collected by focusing on HCRU data for [67 words unchanged] GP practices involved not providing linkage information to Ignite Data to provide to NHS Digital. This left a total subject pool of 629 for linkage. Data is only collected for these 629 individuals. [2 paragraphs unchanged] GSK have requested data for all patients in the INTREPID trial in England, who consented to data linkage to HES. These patients may have been spread throughout England. As GSK wish to utilise centralised secondary care healthcare data from specific English patients, approaching NHS Digital to use their data was the only reasonable way to achieve our GSK's objectives. GASK have only requested the minimum variables required to conduct the analysis. There are not less intrusive ways of achieving the purpose. The objective is to explore the use of linked routine data such as HES to ascertain HCRU. This by definition requires linkage to HES. [1 paragraph unchanged] • GlaxoSmithKline (GSK): The sponsor for the INTREPID study. GSK wish to receive received the final pseudonymised cut of study data, including HES data provided by NHS Digital. GSK are both a data controller and processor for this study. • Ignite Data (IGNITE): IGNITE will have had the explicit consent of participants for receiving their HES data linked to [7 words unchanged] data on GSK’s behalf and pseudonymisation prior to delivery for research. IGNITE will have previously had access to the record level data to complete this work and this has been is made clear to the participants in the study information sheet and Informed Consent Form (ICF) the participants complete. IGNITE will destroy has since destroyed the data once as their involvement in data processing has been completed. IGNITE no longer have any access to the data disseminated under this Agreement. For this reason, IGNITE are no longer considered a Data Processor. The cohort was recruited to the main randomised controlled trial (RCT) element [62 words unchanged] from another local GP Practice or referred to an alternative local site (e.g. (e.g., a hospital). Each patient in the cohort was then consented and managed by this local study site. The RCT data was then collected at a serious series of standard study visits at the patient’s specific study site. GSK are requesting IGNITE receive continued access to record-level identifiable data from the following Hospital Episode Statistics (HES) datasets: [6 paragraphs unchanged] Although the data is commercially funded the outcomes are for the greater public benefit. There is significant focus on cost and burden to the healthcare system. By better understanding the impact of these therapies in the real-world there can be service improvement for all. [1 paragraph unchanged]

Processing activities

[1 paragraph unchanged] 1. Participating practises collect collected consent from patients using ICF and collect patient identifiers including NHS Number, First Name, Surname, Date of Birth and Postcode. 2. Practises transfer transferred copies of completed ICFs and file containing patient identifiers to IGNITE via password protected email. IGNITE store stored ICFs and patient data using Cloud Storage provided by Microsoft Azure. For this reason Microsoft Azure are were previously included as a Data Processor and the appropriate data centre locations have been included in this request. were included. 3. IGNITE then apply applied a unique Study ID to each participant to form a Subject Log of all participants and associated identifiers. 4. IGNITE submit submitted Subject Log containing all cohort data including identifiers to NHS Digital for linkage to HES datasets. 5. NHS Digital provide provided HES data for all 835 initial cohort members to IGNITE via Secure Electronic File Transfer (SEFT). This data will be was received by IGNITE and stored on Cloud Storage provided by Microsoft Azure. 6. IGNITE will link linked NHS Digital data to pseudonymised clinical trial data using Study ID. IGNITE will remove removed all patients’ identifiers except for Study ID. 7. IGNITE will transfer transferred the linked, pseudonymised dataset to GSK for analysis where: [1 paragraph unchanged] In this study, directly identifiable personal and sensitive personal information is determined to be the Participant Surname, Forename, Date of Birth, NHS Number, Address and Post Code. This data is legitimately required by Ignite to hold for administrative purposes and to pass to NHS digital for Participant record identification purposes. IGNITE have the explicit consent of participants for receiving their HES data linked to their unique study ID for processing the data on GSK’s behalf and pseudonymisation prior to delivery for research. IGNITE were listed as a Data Processor in previous iterations of this Agreement. The role of IGNITE, as described above, has been completed. IGNITE have destroyed all copies of the data previously received from NHS Digital and as such, no longer have any access to the data or any continued involvement in the study. As such, IGNITE are no longer considered a Data Processor. The data will be linked to pseudonymised clinical trial data obtained during a patients’ participation using a code (GSK Study ID). This will enhance the understanding of their Healthcare Resource Utilisation during their study participation. The dataset provided by NHS Digital will be pseudonymised using a study specific identifier by IGNITE prior to sending to GSK for analysis. Microsoft Azure cloud was being used by IGNITE to store the data they previously held. They supplied support to the system but did not access data. As such, when IGNITE were removed as a Data Processor from this Agreement, so were Microsoft. Microsoft are not considered as a Data Processor going forward. GSK do not use cloud services to store NHS Digital data under this Agreement. IGNITE will have access to the record level data to complete this work and this has been made clear to the participant in the Patient Information Sheet (PIS) and Informed Consent Form (ICF) the participants have completed. IGNITE will destroy the data once data processing has been complete in-line with GDPR and Good Clinical Practise (GCP) law. GSK had set up a data storage site and workstation in England that allowed authorised GSK analysts to access and analyse the data remotely in North America, whilst ensuring the data and any analytical output remained in England. This was identified as being incompatible with the intent of the licensing provision of the Framework Agreement, as these analysts were based outside the territory of use permitted in the DSA. GSK has since restricted viewing access to the NHS Digital data to GSK staff based only in England or Wales. IGNITE and GSK the only organisations involved in this agreement. At both GSK and IGNITE data access is restricted to specific research teams and is only accessible to members of these teams via role-based access controls to file shares and servers. All members of these teams are substantively employed by IGNITE or GSK. In this study, directly identifiable personal information is determined to be the Participant Surname, Forename, Date of Birth, NHS Number, Address and Post Code. This data was legitimately required by Ignite to hold for administrative purposes and to pass to NHS Digital for Participant record identification purposes. IGNITE had explicit consent of participants for receiving their HES data linked to their unique study ID for processing the data on GSK’s behalf and pseudonymisation prior to delivery for research. The data has been linked to pseudonymised clinical trial data obtained during a patients’ participation using a code (GSK Study ID). This will enhance the understanding of their Healthcare Resource Utilisation during their study participation. The dataset provided by NHS Digital has been pseudonymised using a study specific identifier by IGNITE prior to sending to GSK for analysis. IGNITE previously had access to the record level data to complete this work and this has been made clear to the participant in the Patient Information Sheet (PIS) and Informed Consent Form (ICF) the participants have completed. GSK is the only organisation involved in this Agreement going forward. At GSK, data access is restricted to specific research teams and is only accessible to members of these teams via role-based access controls to file shares and servers. All members of these teams are substantively employed by GSK. [1 paragraph unchanged] Microsoft Ltd provide Azure Backup Storage Services for IGNITE Data Limited and are therefore listed as a data processor. They supply support to the system, but do not access data. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. This includes granting of access to the database[s] containing the data. No record level data disseminated by NHS Digital will leave England and Wales. [1 paragraph unchanged]

Expected measurable benefits

[7 paragraphs unchanged] GSK anticipate that future benefits will follow on from presentations at international conferences and after publications of findings in the peer reviewed literature – i.e., once the findings are disseminated to the wider interested community. GSK aim to submit the findings as an abstract to ISPOR-EU conference due to be held in Nov 2022 and to submit the findings as a manuscript in Q3 2022, and pending journal timelines, GSK estimate publication in Q1 2023. GSK's target date for future benefits is therefore from Q1 2023.

Unchanged: Expected output, Benefits reported.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

Healthcare resource utilisations (HCRU) is the quantifiable measure of a person’s use of services for the purpose of both preventing and curing health problems, the promotion of maintenance of health and wellbeing. Through systematic review the disease burden experienced by both the patient and their healthcare providers can be assessed. GlaxoSmithKline (GSK) requires NHS Digital Hospital Episode Statistics data for the purpose of an exploratory outcome for the Phase 4 study entitled “INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design". The main study has been completed but the exploratory outcome work continues as the feasibility of using national centralised healthcare records to reduce the burden of data collection at research sites is looked at. In this study’s exploratory outcome, the focus is on Healthcare resource utilisations (HCRU) data in several countries including England. The General Data Protection Regulation (GDPR) states that GSK must have a legal basis in law in order to process sensitive data. Article 6 (1) (f) Legitimate interests is cited by GSK since GSK are a Pharmaceutical Company carrying out medical research which is of benefit to science and public health, as described in this Agreement. As special category data, the data is further being processed under article 9(2)(j) (processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes). This is because the consented data will be used to enhance the potential outcomes and improve care, which is in the public interest. All patients have been fully informed of the data processing and the organisations carrying out the data processing. Each individual has provided explicit informed consent. The research provides wider public benefit and the risks to the individuals are low. Healthcare resource utilisations (HCRU) is the quantifiable measure of a person’s use of services for the purpose of both preventing and curing health problems, the promotion of maintenance of health and wellbeing. Through systematic review, the disease burden experienced by the patient and associated healthcare can be assessed. [4 paragraphs unchanged] All-cause HCRU is an overall summary measure of HCRU. For example, this might be expressed as overall number of hospital admissions during follow up for any cause, or overall number of days in hospital during a year. Looking at all-cause HCRU will give a fuller picture of HCRU. Summarising all-cause HCRU will, for example, allow investigation into whether a reduction in COPD HCRU associated with treatment translates to a reduction in HCRU at the all cause level. Importantly, individual causes will not be analysed or reported – this is an overall measure of any HCRU. This is a standard and expected outcome for HCRU analysis of this kind and is required to meet the scientific objectives of the study. [6 paragraphs unchanged] Background to the request [11 paragraphs unchanged] Organisations involved GSK has minimised the data collected by focusing on HCRU data for only those patients who were included in the INTREPID trial and who consented to data linkage to NHS Digital Data. This is a small cohort of patients. The number of current participants in England is 629. The original total possible subject pool for this application in England was 835. After the consenting process, this number was reduced to 702. A further 73 were removed due to the GP practices involved not providing linkage information to Ignite Data to provide NHS Digital. This left a total subject pool of 629 for linkage. Data is only collected for these 629 individuals. GSK also reviewed the data specifications with the case officer and advisors from NHS digital in order to update the original specifications due to changes in the NHS datasets. Any obsolete data (data not absolutely necessary to achieve the scientific objectives of the study,) was omitted from the final request. GSK also limited the years of data requested since the interest is only in data from patients covering the lifetime of the study. Patients were recruited into the study between early 2018 and late 2019, hence only the 3 years of data to cover this period of patient participation has been requested. This is the minimum time period necessary to achieve the scientific objectives of the study. As GSK wish to utilise centralised secondary care healthcare data from specific English patients, approaching NHS Digital to use their data was the only reasonable way to achieve our objectives. Organisations involved: [2 paragraphs unchanged] Cohort Number of participants in England = 835 (this will be the maximum cohort size). [1 paragraph unchanged] Data Summary [7 paragraphs unchanged] General Data Protection Regulation Article 6 (1) (f) Legitimate interests as this is for the benefit of science and public health. All patients have been fully informed of the data processing and the organisations carrying out the data processing. Each individual has provided explicit informed consent. The research provides wider public benefit and the risks to the individuals are low. As special category data, the data is further being processed under article 9(2)(j) (processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes). This is because the consented data will be used to enhance the potential outcomes and improve care, which is in the public interest. [1 paragraph unchanged]

Processing activities

GSK request requested access to the data under the data flows described below: [4 paragraphs unchanged] 5. NHS Digital provide HES data for all 835 initial cohort members to IGNITE via Secure Electronic File Transfer (SEFT). This data will be received by IGNITE and stored on Cloud Storage provided by Microsoft Azure. [9 paragraphs unchanged] NHS Digital reminds all organisations party to this agreement of the need [17 words unchanged] that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).

Expected output

[5 paragraphs unchanged] The last patient last visit for the INTREPID study was October 2019. [12 words unchanged] begun. At present, it is estimated that initial results may be published from early 2022. GSK aim to submit findings to conferences for presentation in mid 2022 and peer reviewed journals for anticipated publication in 2022/2023. GSK aim to late 2021. submit to conferences and journals where the findings presented will inform practice and policy. For example, by selecting target conferences and journals with both respiratory clinical as well as a health economics audience. [1 paragraph unchanged]

Expected measurable benefits

A full picture of the real-world implications of COPD and its treatment can only be formed when all interactions with the healthcare services can be appraised. The It is hoped the results from this study will provide insight into how real-world patients interacted with the UK healthcare system whilst they participated in this study. The dissemination of this information will is planned be included into the wider outputs of the INTREPID study, where the [18 words unchanged] Chronic Obstructive Pulmonary Disease (COPD) control within the usual clinical practice setting. Improved It is hoped that improved understanding of COPD and its treatment will improve patient outcomes and reduce the burden on the UK healthcare service by: [3 paragraphs unchanged] As the second most common reason for emergency medical admission in the [16 words unchanged] better understand the healthcare resource utilisation of patients included in this study. The It is hoped that the dissemination of this information will expand the understanding of disease burden for [27 words unchanged] the organisation and delivery of care. The information generated from this analysis will, should, for example, provide valuable information on which aspects of secondary care represent [64 words unchanged] could be spent on another area, for example on preventative healthcare services. [1 paragraph unchanged] GSK aim to submit to conferences and journals where the findings presented will inform practice and policy, for example, by selecting target conferences and journals with both respiratory clinical as well as a health economics audience. Following the dissemination of these findings (targeted for 2022), GSK also aim to engage with their strategic partners, for example BREATHE, the respiratory hub for HDR UK (the UK’s National Institute for Health Data Science) in order improve the clinical research community’s ability to understand how medical research can be conducted and answer these types of questions more effectively and efficiently in the UK using these types of data (for example, future digitally enabled trials).

Benefits reported

Yielded Benefits is not a requirement for new applications. No benefits have been yielded to date. Due to delays in receiving the data from NHS Digital, resulting from the pandemic, quality checks of the data prior to analysis are only just being completed.