A Study of Cardiovascular Events iN Diabetes – PLUS (ASCEND PLUS) - Recruitment agreement
University of Oxford · Academic
In term In term in the September 2026 edition: the latest version runs to 6 December 2026.
- Reference
- DARS-NIC-655024-S2H5Q
- Current version
- v2.2
- Term of current version
- 7 December 2024 to 6 December 2026
- Start date
- 7 December 2022
- Data controller
- Sole Data Controller
- Commercial purposes
- Yes
- Sublicensing
- No
- Files released to date
- 0
Why the data was released
Objective for processing
BACKGROUND
Around one in 11 adults worldwide has diabetes: a long-term condition where a person’s blood sugar levels are too high.
There are two main types of diabetes:
• Type 1 diabetes – where the body’s immune system attacks and destroys the cells that produce the hormone insulin so that no insulin is produced. This is treated with insulin injections.
• Type 2 diabetes – where the body does not produce enough insulin, or the body’s cells do not react to insulin. This usually occurs later in life and is often treated with tablets. Some patients eventually need to be treated with insulin.
People with diabetes are more likely to suffer from other major health problems. These include heart and circulatory problems (including heart attacks and strokes), high blood pressure and dementia. Diabetes can cause kidney disease, problems with feeling in the feet, and eye problems that may affect vision.
ASCEND PLUS is a clinical trial led by the University of Oxford. It is a randomised, double-blind, parallel-group, placebo-controlled event driven trial designed to test the hypothesis that oral semaglutide reduces cardiovascular events and other complications of diabetes in people with type 2 diabetes mellitus (T2DM) without a prior heart attack or stroke. The study will use streamlined methodology to randomise approximately 20,000 people with T2DM in the UK and follow them during a scheduled treatment period with a median duration of approximately 5 years.
OUTCOMES DATA (Not part of this agreement however for future information)
With consent, the ASCEND PLUS team will collect linked healthcare data from NHS England and other organisations for the 5-year scheduled treatment period and the following 20 years in order to find out the medium and long-term effects of oral semaglutide (this linkage for consented trial participants will be covered by a separate Data Sharing Agreement).
THE AIM OF THE TRIAL
The ASCEND PLUS trial aims to provide evidence about both the efficacy and safety of prolonged treatment with oral semaglutide. The hypothesis of the ASCEND PLUS trial is that treatment with oral semaglutide reduces cardiovascular events and other complications of diabetes in individuals aged at least 55 years, with T2DM, without a history of a heart attack or stroke, and without any upper or lower Haemoglobin A1c (HbA1c) threshold.
STUDY TEAM
Any reference to "the study team" in this agreement refers to members staff substantively employed by University of Oxford directly working on the ASCEND PLUS programme.
PATIENT AND PUBLIC INVOLVEMENT AND ENGAGEMENT (PPIE)
Two lay members were recruitment to the trial Steering Committee (TSC) and attended the first TSC meeting in June 2021 and subsequent meetings, ensuring patient and public involvement in the high-level strategic decisions for the trial.
Between June and October 2021, the ASCEND PLUS team convened six patient and public focus groups, largely involving people with type 2 diabetes. The groups included people from diverse backgrounds across the UK, with the exception of Northern Ireland, as the trial will not take place in this location. The trial’s proposed consent model formed a key focus of each group. There was strong support for potential trial participants to have a choice of consent method (self-directed online consent or consent via nurse telephone or video call interview). The trial procedures were amended in light of the advice from these groups to offer this choice within the reply form. The use of patient data without consent (to invite patients to join the study) formed a focus of the group discussions at 5 of the meetings. There was broad support for this process to enable the study to recruit the large number of participants required.
The trial has convened the ASCEND PLUS Public Advisory Group (ASCEND PAG), a diverse group of patients and public, to input into the whole life-cycle of the trial. Members were recruited from the existing Nuffield Department of Population Health public advisory panel and the focus groups described above. The ASCEND PAG give feedback, advice and opinions across different aspects of the trial including recruitment materials, participant questionnaires, website development, strategies to maintain participant adherence and engagement, and dissemination of the trial results. The first meeting was held on 6 September 2021. Group members have subsequently provided input into all the patient-facing trial documents. As a result of feedback from the ASCEND PAG and the focus groups, the material was divided into three leaflets; an initial information leaflet to be sent out with the invitation letter and then a full participant information leaflet and a separate data protection leaflet, which are to be sent to individuals who express an interest in the trial. Text and content change recommendations from ASCEND PAG members were implemented throughout, unless these were inconsistent with the study processes.
This has resulted in documents which are easier to understand and more inclusive. For example, for the invitation letter, ASCEND PAG members edited the transparency notice wording to plain English and added the text box, ‘If you would like this information in a non-English language or other format, such as large print, please contact us’ to the start of the invitation letter. In other places, the ASCEND PAG requested a change to the order of the information presented. For example in the participant information leaflet the section, ‘Will taking part affect my medical insurance or travelling?’ was moved earlier in the document.
The ASCEND PAG also co-developed the consent animation, which is part of the self-directed online consent process. First they contributed to the development of the script and then provided feedback on the images used in the storyboard, most of which were implemented. The ASCEND PAG was also instrumental in the selection of which quality of life questionnaires to include in the protocol and have reviewed the draft screening form questions and provided detailed feedback.
To optimise the wording for the letter invites, NHS DigiTrials team in NHS England have tested different letter variants with members of the public. Initially, NHS DigiTrials conducted desk research and developed hypotheses on behavioural techniques that would help optimise invitation letters.
NHS DigiTrials analysed the results and focussed on people with Type II Diabetes in order to help inform invites for the ASCEND PLUS trial. For people with this health condition, all experimental letter variants outperformed the control on all reported measures of taking action. As a result of this, the content of the invitation letters for the ASCEND PLUS trial may be amended slightly to align with the optimum performing letters from the testing
LEGAL BASIS FOR COMMON LAW DUTY OF CONFIDENTIALITY
University of Oxford as data controller, are requesting to use NHS England data to support a clinical trial called ASCEND PLUS. This agreement is specifically to support the recruitment of a cohort by writing out to individuals who meet the required eligibility criteria.
For the first element of the recruitment process, the legal basis for the identifiable data from NHS England to flow to Paragon Customer Communications Ltd (Paragon CC) for the purpose of University of Oxford inviting them to join the ASCEND PLUS trial is Section 251 approval (NHS Act 2006), approved by the Confidentiality Advisory Group (CAG).
For the second element of the recruitment process, the University of Oxford are relying on consent. Interested potential participants will return a reply form to University of Oxford which will include consent to obtain participant information. Further details on this are detailed within Processing Activities section.
GDPR LEGAL BASIS FOR PROCESSING OF PERSONAL DATA
University of Oxford, as sole Data Controller, are using Article 6(1)(e) "processing is necessary for the performance of a task in the public interest or in the exercise of official authority vested in the controller." As part of the application process, the requirement for the data requested has been assessed and NHS England is content that it is appropriate, necessary and proportionate for the performance of the task described in the purpose statement and that there is no other reasonable and less intrusive means for the data processor to achieve their purpose.
It is acknowledged that University of Oxford has no direct relationship with the potential research participants up until the time (if they choose to) they respond to the postal invitation by returning the reply form to University of Oxford. At that point, University of Oxford relies on the potential research participant’s consent to
A) obtain participant identifiable information from NHS England, and
B) issue the participant with more information regarding the trial and make contact to undergo trial screening and solicit consent to participate in the trial.
Potential participants may experience minor inconvenience of being contacted and invited to take part in the research programme. However, the inconvenience is restricted to the receipt of a letter through the post. Therefore, the likelihood of any adverse impact on the data subjects is low and the severity of any such impact is judged to be minimal.
Additionally (as health data is a special category of Personal Data), University of Oxford is using Article 9(2)(j): Special category data used for “Archiving in the public interest, scientific or historical research or statistical purposes”. If the Study Team demonstrate that oral semaglutide is beneficial in a wide range of patients with type 2 diabetes then the results could change national and international guidelines and more patients could be offered the treatment. This should reduce the risk of complications in patients with diabetes which is in the interest of the public.
INCLUSION AND EXCLUSION CRITERIA FOR INVITATION
The trial will be conducted throughout the UK* and the aim is to recruit a total of 20,000 participants. It is anticipated that about 18,000 of these participants will be recruitment through the collaboration with NHS England in England but this may change as the trial recruitment progresses.
Lists of potentially eligible individuals will be generated from electronic searches of centrally held NHS datasets at NHS England
*NOTE: NHS England will be providing data for England only. The study will be obtaining the related data from the other devolved nations from the relevant organisations.
Invitation inclusion criteria:
• Reside within England
• Age at least 55 years (this is to ensure that the individuals taking part in the trial are at sufficiently high risk of the relevant cardiovascular disease outcomes (e.g. heart attack and stroke).
• Have type 2 diabetes (based on either a relevant diabetes ICD-10 code in their Hospital Episode Statistics data and/or receipt of diabetes treatment in the NHSBSA Medicines data)
Invitation exclusion criteria:
The overall cohort of participant aims to be representative across UK geographical locations, age, and gender. It is possible as part of the creation of each NHS England mailout, that specific criteria will be applied to the searches to create the invitee list for that mailout. This may involve increasing the proportion of invitees from particular criteria groups to facilitate balancing the overall cohort make up.
In addition, participants should not have a recorded history of heart attack, stroke, recent cancer or dementia.
Recruitment is expected to begin around December 2022 and take place over 2 years. For the first year of recruitment, approximately half a million patients will be identified and contacted. With an assumed response through to randomisation rate of 2%- , approximately 9,000 patients should be recruited, however this recruitment target is an estimate and may be subject to change. The study team anticipate that a further half million invites will be required in the second year, however, should the study team require a substantial change to the recruitment target or number of invitees, an amendment to this agreement will be required with justification for the change, with appropriate Ethics and CAG approval.
REQUESTING NOT TO TAKE PART IN THE PROGRAMME:
In addition to the National Data Opt-out, members of the public will be able to specifically request not to be contacted for the ASCEND PLUS trial. University of Oxford will promote this information via the dedicated programme website (http://www.ascend-plus-trial.org) and via local media for two weeks prior to letters being issued to enable those who do not wish to receive a letter to declare this. NHS England will also promote this information via a dedicated page on its website (http://digital.nhs.uk/ascend-plus). There will also be an option for people to register their request not to take part in ASCEND plus by telephone. In order to provide a single point of contact for all trial related queries, individuals who do not want to be contacted for ASCEND PLUS but are unable to access the study-specific opt-out form on the NHS England website will be asked to call the trial Freephone number at the University of Oxford. The trained switchboard team will then record the study specific opt-out on the NHS England website on the individuals behalf with no personal data entered into the University of Oxford systems.
NHS England will ensure that anyone who has registered for the study specific opt-out will be excluded from the cohort selection and as a result their details will not be on the list passed to Paragon CC for invitations to be sent.
MAILOUTS
Potential participant will be sent one invitation for the ASCEND PLUS trial unless any of the following criteria apply:
1. A national data opt-out has been applied
2. A trial specific opt-out has been applied
Each letter will be mailed with a reply form and the Initial Information Leaflet.
ORGANISATION’S ROLES AND RESPONSIBILITIES:
University of Oxford is the applicant and data controller, who also process data. They are responsible for the programme and overseeing the work carried out to aid recruitment into the programme. They are also responsible for providing the core eligibility criteria for participants.
University of Oxford are responsible for:
1. Generating the invitation request(s) and sending to NHS England on a regular basis
2. Monitoring uptake by invitees (i.e. numbers of invitees consenting to participate in the programme)
3. Monitoring scope of the population sending back reply forms
4. Adjusting the selection criteria for invitations to adjust for underrepresentation of target populations taking up the programme, as necessary.
5. Compiling weekly cohorts of interested participants (from the returned reply forms) and securely transferring to NHS England for linkage with further participant identifiers and vital status.
NHS England are acting as a data processor on behalf of University of Oxford and are responsible for:
1. Applying the inclusion and exclusion criteria to NHS England Datasets to generate a list of invitees
2. Feeding back to University of Oxford the number of invitees actually fulfilled out of the total target population, via an aggregate report with small numbers suppressed.
3. Removing objections or opt outs (where a national data opt-out has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.)
4. Sending the list of invitees on to University of Oxford's third-party provider (Paragon Customer Communications Ltd) for generating the invitation letters and mailing these out
5. Agreeing with University of Oxford key processing timelines, including
a. Time from submission to Paragon Customer Communications to mailout
b. Date of the mail outs
c. Daily cut-off times (i.e. after which processing will take place the next day)
d. Time to feedback to University of Oxford the numbers selected
6. Where the number of invitees is less than the population available, invoking a system to choose invitees at random
7. Maintaining a record of people who have returned reply forms to University of Oxford (details of which University of Oxford will supply to NHS England securely via Secure Electronic File Transfer (SEFT) and ensuring that these participants are excluded from a second or any further rounds of invitations.
8. Maintaining a record of people invited to the study ensuring they are excluded from any further rounds of invitations.
9. Processing the cohort of interested participants (approximately on a weekly basis) and providing vital status update and updated cohort information securely back to University of Oxford.
10. Processing the cohort of interested participants (on an ad-hoc basis) against the cohort of invitees to produce an aggregate recruitment conversion report, with small numbers suppressed. This report is to be securely shared with University of Oxford.
Paragon Customer Communications are acting as a processor of University of Oxford. Their responsibility is to receive the lists of invitees from NHS England and mail out to them accordingly.
A 'return to sender' address will need to be included on the letters. When letters are unable to be delivered to the participant address provided by NHS England - they will be returned to Paragon Customer Communications where they will be shredded. Paragon Customer Communications will provide University of Oxford with an aggregate report of number of returned letters.
***ADDITION OF A DATA PROCESSOR - Version 1 of this agreement - January 2023***
Atos IT services UK Limited - Paragon Customer Communications are shortly to sign a contract with Atos IT services Limited as a sub-processor who would also store and process NHS England data. Therefore, in anticipation of this contract being signed, this data sharing agreement has been uplifted to include Atos IT services UK Limited as a data processor.
Atos IT services UK Limited has been appointed to provide various services under the Managed IT services contract from Paragon CC. These are listed below. Under each service banner Atos IT services UK Limited pre-vetted resources will have access to Paragon's IT estate in order to deliver the required support and services. In some cases, Atos IT services UK Limited resources will have direct or indirect access to client data.
1. Service desk and IT service management
2. Hosting and networks infrastructure
3. End user compute
4. Application development, support and maintenance
5. Information security services
Whilst the data will remain resident onshore in UK data centres only, there may be instances where data may be viewed by authorised Atos IT services UK Limited employees from outside the UK and EU, but this is on a read-only basis and there are processes in place so files/data cannot be downloaded to the employee’s location.
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FUNDING and COMMERCIAL PURPOSE.
The ASCEND PLUS trial was initiated and designed by investigators at the University of Oxford aiming to improve the health of people with type 2 diabetes. The trial is funded through a grant to the University of Oxford from Novo Nordisk, a Danish multinational pharmaceutical company. Additionally, Novo Nordisk - who manufacture the treatment being studied, oral semaglutide - will also be providing the study treatment for the trial. Oral semaglutide is the only oral medication in this class. There are other drugs in this class produced by other companies, however these are given by injection so would not be suitable for the ASCEND PLUS trial design and may be more difficult for patients to take. This is why the study team approached Novo Nordisk rather than any other manufacturer for this study. In the interests of transparency, it is stated here that if the results show that oral semaglutide is beneficial for a wide range of people with diabetes, then this could also increase revenue for the manufacturer Novo Nordisk. Nordisk will have no influence over any of the findings and will have no ability to suppress any outputs produced by the study.
NHS England record level data covered by this Data Sharing Agreement will not be shared with any funders and final decision making on processing of the data rests with University of Oxford senior trial management team who are all substantive employees, therefore the funders are not considered Data Controllers or Data Processors on this agreement. The ASCEND PLUS study is sponsored by The University of Oxford. The protocol and procedures have been developed by the investigators at the Clinical Trial Service Unit, University of Oxford with contributions from Novo Nordisk. The Steering Committee determine the scientific objectives of the trial, ensure adequate progress towards those objectives and review any papers prior to publication. As is usual with this type of trial, the Steering Committee has representatives from the funder and also has other experts from other institutions to advise the trial management team. The Steering Group will not have access to or process any NHS England record-level Data.
Processing activities
As data controller, the University of Oxford will provide to NHS England the core eligibility criteria for those potential participants who will receive the initial invitation letters and information sheets. University of Oxford refine the population that receive these invitations based on first half of a postcode, making adjustments as required to ensure adequate representation of target populations.
NHS England would be using a mailing provider, Paragon Customer Communications Ltd (and by association its contracted sub-processor Atos IT services UK Limited), to fulfil the communications. Paragon Customer Communications Ltd will use Research Ethics Committee (REC)-approved template invitation letters and would add address details and unique barcode references onto the letters prior to mailing it out. All identifiable data provided to Paragon Customer Communications by NHS England will be done so under the legal basis of Section 251 support as provided by the Confidentiality Advisory Group (CAG) for this element of the ASCEND PLUS trial recruitment.
Data processing is carried out by employees of NHS England who have been appropriately trained in data protection and confidentiality. NHS England will access records allowing them to gather the following information needed to determine suitability for invitation to the ASCEND PLUS trial.
COHORT SPECIFICATION:
• University of Oxford are accountable for providing the specification to NHS England for each mail out. These specifications will be based on a combination of multiple postcodes, age limits, sex at birth and ethnicities for potential participants. The information they will provide to NHS England on each occasion is:
• Lower and upper age limits (55 and over as per the inclusion criteria).
• Male / female percentage split, if required.
• A selection of postcodes (first half of postcode only), if required.
• The number of invitations required for each request.
• The geographical specifications are based on ensuring a broad range of individuals from across England.
• At a pre-determined point, University of Oxford will transfer details of the specification to NHS England via SEFT. This will be on a flexible ad-hoc basis, determined by the number of responses received for each request, but could be up to once weekly.
COHORT IDENTIFICATION:
• Using the inclusion and exclusion criteria as specified by University of Oxford, NHS England will interrogate the Patient Demographics Service (PDS), NHS Business Services Authority (NHSBSA) Medicines Dispensed in Primary Care and the Hospital Episode Statistics (HES) datasets and extract all those potential participants who meet the criteria within the latest specification as provided by University of Oxford.*
• NHS England will then remove any records where a national data opt-out has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.
• The remaining records will have their relevant contact details (Forename, Surname, Address, Postcode) extracted ready for despatch to Paragon , as well as a unique barcode reference for each potential participant.
*NOTE: Although the HES APC and NHSBSA Medicines datasets are being cross-referenced to produce the cohort of potential participants for this agreement, these datasets are not considered as data products on this Data Sharing Agreement as no record level HES APC or NHSBSA Medicines data will be shared with either University of Oxford or Paragon Customer Communications (or by association its contracted sub-processor Atos IT services UK Limited). The processing of HES APC and NHSBSA Medicines data is covered under a separate Data Processing Agreement between NHS England and University of Oxford
COHORT DISSEMINATION AND MAILOUT
• Each time NHS England create and disseminate an extract, the records will be added to a mailing list cohort dataset, including individual participant IDs.
• Every time a fresh extract is produced, it will be checked to ensure that any records appearing in this mailing list dataset are removed in order to prevent potential participants receiving multiple invitations.
• NHS England will provide Paragon Customer Communications with Forename, Surname, Address, Postcode and Unique barcode reference via SEFT.
• Paragon Customer Communications will then mail out to individuals as required.
• All potential participants will receive an invitation letter containing their Name, Address and Postcode and Unique barcode reference,
• Paragon Customer Communications will destroy all data received from NHS England 30 days after mailing as instructed by the University of Oxford.
PARTICIPANT EXPRESSION OF INTEREST VIA CONSENT REPLY FORM
The invitation letter is mailed with an enclosed Initial Information Leaflet, a Reply Form and a Freepost envelope. The information includes the Freephone telephone number of the ASCEND PLUS team, the study e-mail address and the study website URL, so that potential participants can find out more about the study at this stage if they chose. If the recipient is potentially interested in taking part, they are asked to complete the Reply Form. This is pre-populated with the person's name and unique barcode reference. The potential participant is asked to add their telephone number and e-mail address and indicate whether they would prefer to engage with the study online or via telephone / video call with a research nurse. They can also add any special requirements such as large print or non-English language. By returning the Reply Form the potential participant is giving permission for the University of Oxford to receive their personal data including receiving their Name, address, postcode, NHS number, date of birth, gender and GP practice details from NHS England, so that the study team can complete the screening assessment, and, if they are eligible and consent to the study, inform their GP. Each reply form is checked and logged by the study team. The name and unique identifier will be extracted from the Reply Form using a barcode scanner to reduce errors. Permission to use personal details in order for University of Oxford to make further contact is clearly described on the reply form.
INTERESTED PARTICIPANT COHORT LINKAGE TO ADDITIONAL DATA
On a weekly basis, the University of Oxford will securely provide NHS England with the unique identifiers (barcode reference) for all those individuals who have returned their reply form. NHS England will use the unique barcode reference to link back to the potential participants full name, address, postcode, NHS Number, date of birth, gender and GP practice details, from the Demographics dataset. These data items will be returned securely to University of Oxford via SEFT.
Personal data for patients who have return the reply form (and therefore given permission for University of Oxford to receive their details in order to do the screening assessment) but then either don’t complete the screening assessment or are not eligible at screening and so don’t provide full informed consent for the trial will be held until the end of recruitment and then destroyed. University of Oxford retain this data until the end of recruitment in case a potential participant changes their mind and decides to attend screening, becomes eligible or has any other queries about the trial. University of Oxford feel this is in line with their permission given by returning the reply form. After recruitment is completed and there is no possibility of them completing the screening assessment and therefore no rationale for University of Oxford to hold their personal data longer.
AGGREGATE RECRUITMENT CONVERSION REPORT
On an ad-hoc basis (up to once a week), NHS England will compare the cohort of invitees to the cohort of interested participants (who have returned their reply form to University of Oxford) to produce a report detailing the percentage uptake of participants in relation to the inclusion and exclusion criteria provided by University of Oxford. This report will only contain aggregate data with small numbers suppressed and is represented within this Data Sharing Agreement under section 3B (Additional Data Access Requested) as “Customer – Data Quality Report – Aggregate (Communications)”
The permitted territory of use for data provided by NHS England for this agreement is UK.
Potential participants will receive one postal invitation for the ASCEND PLUS study; at present there will be no further attempts to remind or re-approach patients who do not respond. The study team may consider sending out an additional reminder in future, and if required, will submit an amendment to this agreement and seek relevant ethical approval. It is possible that patients who move from England to Wales or Scotland during the recruitment period, may receive a further invitation from a search conducted by other data custodians in those regions but this is likely to only affect a small number of individuals and an explanation would be provided.
An aggregate report with small numbers supressed (as per the HES Analysis Guide) containing information about gender, age and geographic demographics of the mailing cohort will be provided to University of Oxford from NHS England for the purposes of confirming that inclusion and exclusion criteria have been met for each mailing. This report will also contain the total number of people who received the mail out and the number of people removed from the cohort prior to mailing based on trial-specific opt out, national data opt out and special categories of people for whom the data should not be disseminated, such as those on a witness protection programme.
The data from NHS England will not be used for any other purpose other than that outlined in this Agreement. The data from NHS England will not be linked to any other data other than those outlined in this Agreement.
HES and ECDS DISCLOSURE CONTROL / SMALL NUMBER SUPPRESSION
In order to protect patient confidentiality, when presenting results calculated from HES record level data, outputs will contain only aggregate level data with small numbers suppressed in line with HES Analysis Guide. When publishing HES data, data processors must make sure that:
• National-level figures only may be presented unrounded, without small number suppression
• cell values from 1 to 7 (inclusive) are suppressed at a sub-national level to prevent possible identification of individuals from small counts within the table.
• Zeros (0) do not need to be suppressed.
• All other counts will be rounded to the nearest 5.
Data will not be made available to any third parties other than those specified except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.
Expected output
As a result of this recruitment agreement with NHS DigiTrials, the ASCEND plus study team are hoping to recruit to target having posted out adequate numbers of invitations to potentially eligible participants.
Identifiable health data requested from NHS England will only be used to identify and invite potential participants. NHS England record Level Identifiable data will only be available to University of Oxford after participants have expressed interest and returned the consenting reply form.
Progress against recruitment targets may be reported to the University of Oxford, the funder Novo Nordisk and the Trials Steering Committee in an aggregated and suppressed format.
Key recruitment targets have been set for first year of recruitment and will be closely monitored and reported. NHS DigiTrials forms the main route to recruitment for the trial and the sole method of recruitment in England.
Successful recruitment will enable to trial to test the effects of oral semaglutide in a wide range of people with type diabetes. The main results of the trial are expected in 2028 and should inform National and International guidelines. Examples of these guidelines could include the NICE guideline on “Type 2 diabetes in adults: management”, the American Diabetes Association Standards of Medical Care in Diabetes guidelines and the diabetes guidelines from the European Society of Cardiology and the European Association for the Study of Diabetes. The study team aim to publish the main trail report in a high-impact medical journal with a public summary on the trial website.
Results will also be communicated directly to trial participants.
Expected measurable benefits
One in 11 people worldwide has diabetes including around 5M people in the UK. Individuals with diabetes have increased risks of adverse cardiovascular health outcomes (such as heart attacks and strokes) which can be fatal or disabling, and of other health problems such as dementia. People with diabetes can also develop complications such as kidney disease, reduced vision, amputation and pain or numbness in their feet (neuropathy). There are several new treatments for diabetes, including oral semaglutide and similar drugs given by injection, but clinical trials have only tested them in selected individuals with very high cardiovascular risks.
ASCEND PLUS is testing oral semaglutide, the first oral Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA), in a wide range of people with type 2 diabetes. The main aim is to assess the effects of the treatment on adverse cardiovascular health outcomes but the trial will also assess effects on other complications of diabetes. Oral semaglutide and other GLP-1 RAs control blood sugar, reduce weight and, in high-risk patients, reduce the risk of adverse cardiovascular health outcomes. However, these medications are not widely used, partly because they have not been shown to be beneficial in most patients with type 2 diabetes who don’t already have cardiovascular disease. The trial will also be able to find out the long-term effects of oral semaglutide. There is some evidence that oral semaglutide may protect against dementia and kidney disease but this is not proven.
If ASCEND PLUS shows that oral semaglutide is beneficial in a wide range of patients with type 2 diabetes then the results could change national and international guidelines and more patients could be offered the treatment. This should reduce the risk of complications in patients with diabetes.
The main results are expected in 2028 with long-term follow-up continuing for 20 years after that. The study team aims to present results at scientific conferences and publish in high-impact peer reviewed journals. The study team plan to distribute plain English results co-developed by the ASCEND PAG to surviving study participants by mail and shared with the public via the trial website.
The trial should also generate important methodological insights, tools and resources to benefit future research. These will be share where possible during the trial through presentations, publications and via collaboration with Health Data Research UK and the MRC-NIHR Trials Methodology Research Partnership.
Benefits reported so far
This Data Sharing Agreement with NHS England has enabled effective and fast recruitment of participants into the ASCEND PLUS clinical trial.
As of the week commencing 25th November 2024, ASCEND PLUS has screened 20,000 participants, 15,000 have entered the run-in period, and 9,200 have been randomised. This has been achieved over just 18-months (excepting a very small initial mailing). Compared to the original ASCEND trial (also a mail-based study), recruitment to ASCEND PLUS has been 2 to 3 times faster.
Datasets on the current version
Legal basis for provision: Health and Social Care Act 2012 – s261(2)(b)(ii); Health and Social Care Act 2012 – s261(2)(c); Health and Social Care Act 2012 - s261(2)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
| Dataset | Type of data | Sensitivity | Frequency | Confidential data |
|---|---|---|---|---|
| Customer - Data Quality Report - Aggregate (Comms) | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Mixture of confidential data flow(s) with consent and flow(s) with support under section 251 NHS Act 2006 |
| Customer - Data Quality Report - Aggregate (Recruitment) | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Mixture of confidential data flow(s) with consent and flow(s) with support under section 251 NHS Act 2006 |
| Demographics | Identifiable | Sensitive | One-Off | Mixture of confidential data flow(s) with consent and flow(s) with support under section 251 NHS Act 2006 |
| Mailing - Cohort - Non-aggregate (Comms & Recruitment) | Identifiable | Sensitive | One-Off | Mixture of confidential data flow(s) with consent and flow(s) with support under section 251 NHS Act 2006 |
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 3 versions.
DARS-NIC-655024-S2H5Q-v2.2 7 December 2024 to 6 December 2026
- Title
- A Study of Cardiovascular Events iN Diabetes – PLUS (ASCEND PLUS) - Recruitment agreement
- Commercial
- Yes
- Sublicensing
- No
- Datasets
- 4
- Files released
- 0
Datasets: Customer - Data Quality Report - Aggregate (Comms); Customer - Data Quality Report - Aggregate (Recruitment); Demographics; Mailing - Cohort - Non-aggregate (Comms & Recruitment)
What changed from DARS-NIC-655024-S2H5Q-v1.2
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2024-12-07 | |
| End date | 2026-12-06 |
Objective for processing
[8 paragraphs unchanged]
With consent, the ASCEND PLUS team will collect linked healthcare data from NHS
Digital
England
and other organisations for the 5-year scheduled treatment period and the following
[18 words unchanged]
consented trial participants will be covered by a separate Data Sharing Agreement).
[10 paragraphs unchanged]
To optimise the wording for the letter invites, NHS DigiTrials team in NHS
Digital
England
have tested different letter variants with members of the public. Initially, NHS DigiTrials conducted desk research and developed hypotheses on behavioural techniques that would help optimise invitation letters.
[2 paragraphs unchanged]
University of Oxford as data controller, are requesting to use NHS
Digital
England
data to support a clinical trial called ASCEND PLUS. This agreement is
[7 words unchanged]
cohort by writing out to individuals who meet the required eligibility criteria.
For the first element of the recruitment process, the legal basis for the identifiable data from NHS
Digital
England
to flow to Paragon Customer Communications Ltd (Paragon CC) for the purpose
[14 words unchanged]
251 approval (NHS Act 2006), approved by the Confidentiality Advisory Group (CAG).
[2 paragraphs unchanged]
University of Oxford, as sole Data Controller, are using Article 6(1)(e) "processing
[28 words unchanged]
process, the requirement for the data requested has been assessed and NHS
Digital
England
is content that it is appropriate, necessary and proportionate for the performance
[15 words unchanged]
and less intrusive means for the data processor to achieve their purpose.
[1 paragraph unchanged]
A) obtain participant identifiable information from NHS
Digital,
England,
and
[4 paragraphs unchanged]
The trial will be conducted throughout the UK* and the aim is
[12 words unchanged]
18,000 of these participants will be recruitment through the collaboration with NHS
Digital
England
in England but this may change as the trial recruitment progresses.
Lists of potentially eligible individuals will be generated from electronic searches of centrally held NHS datasets at NHS
Digital
England
*NOTE: NHS
Digital
England
will be providing data for England only. The study will be obtaining the related data from the other devolved nations from the relevant organisations.
[5 paragraphs unchanged]
The overall cohort of participant aims to be representative across UK geographical locations, age, and gender. It is possible as part of the creation of each NHS
Digital
England
mailout, that specific criteria will be applied to the searches to create
[14 words unchanged]
from particular criteria groups to facilitate balancing the overall cohort make up.
[3 paragraphs unchanged]
In addition to the National Data Opt-out, members of the public will
[42 words unchanged]
who do not wish to receive a letter to declare this. NHS
Digital
England
will also promote this information via a dedicated page on its website
[47 words unchanged]
but are unable to access the study-specific opt-out form on the NHS
Digital
England
website will be asked to call the trial Freephone number at the
[5 words unchanged]
switchboard team will then record the study specific opt-out on the NHS
Digital
England
website on the individuals behalf with no personal data entered into the University of Oxford systems.
NHS
Digital
England
will ensure that anyone who has registered for the study specific opt-out
[16 words unchanged]
on the list passed to Paragon CC for invitations to be sent.
[8 paragraphs unchanged]
1. Generating the invitation request(s) and sending to NHS
Digital
England
on a regular basis
[3 paragraphs unchanged]
5. Compiling weekly cohorts of interested participants (from the returned reply forms) and securely transferring to NHS
Digital
England
for linkage with further participant identifiers and vital status.
NHS
Digital
England
are acting as a data processor on behalf of University of Oxford and are responsible for:
1. Applying the inclusion and exclusion criteria to NHS
Digital
England
Datasets to generate a list of invitees
[9 paragraphs unchanged]
7. Maintaining a record of people who have returned reply forms to University of Oxford (details of which University of Oxford will supply to NHS
Digital
England
securely via Secure Electronic File Transfer (SEFT) and ensuring that these participants are excluded from a second or any further rounds of invitations.
[3 paragraphs unchanged]
Paragon Customer Communications are acting as a processor of University of Oxford. Their responsibility is to receive the lists of invitees from NHS
Digital
England
and mail out to them accordingly.
A 'return to sender' address will need to be included on the letters. When letters are unable to be delivered to the participant address provided by NHS
Digital
England
- they will be returned to Paragon Customer Communications where they will
[7 words unchanged]
University of Oxford with an aggregate report of number of returned letters.
[1 paragraph unchanged]
Atos IT services UK Limited - Paragon Customer Communications are shortly to
[6 words unchanged]
services Limited as a sub-processor who would also store and process NHS
Digital
England
data. Therefore, in anticipation of this contract being signed, this data sharing agreement has been uplifted to include Atos IT services UK Limited as a data processor.
[10 paragraphs unchanged]
NHS
Digital
England
record level data covered by this Data Sharing Agreement will not be
[129 words unchanged]
The Steering Group will not have access to or process any NHS
Digital
England
record-level Data.
Processing activities
As data controller, the University of Oxford will provide to NHS
Digital
England
the core eligibility criteria for those potential participants who will receive the
[22 words unchanged]
postcode, making adjustments as required to ensure adequate representation of target populations.
NHS
Digital
England
would be using a mailing provider, Paragon Customer Communications Ltd (and by
[41 words unchanged]
it out. All identifiable data provided to Paragon Customer Communications by NHS
Digital
England
will be done so under the legal basis of Section 251 support
[5 words unchanged]
Advisory Group (CAG) for this element of the ASCEND PLUS trial recruitment.
Data processing is carried out by employees of NHS
Digital
England
who have been appropriately trained in data protection and confidentiality. NHS
Digital
England
will access records allowing them to gather the following information needed to determine suitability for invitation to the ASCEND PLUS trial.
[1 paragraph unchanged]
• University of Oxford are accountable for providing the specification to NHS
Digital
England
for each mail out. These specifications will be based on a combination
[8 words unchanged]
and ethnicities for potential participants. The information they will provide to NHS
Digital
England
on each occasion is:
[5 paragraphs unchanged]
• At a pre-determined point, University of Oxford will transfer details of the specification to NHS
Digital
England
via SEFT. This will be on a flexible ad-hoc basis, determined by the number of responses received for each request, but could be up to once weekly.
[1 paragraph unchanged]
• Using the inclusion and exclusion criteria as specified by University of Oxford, NHS
Digital
England
will interrogate the Patient Demographics Service (PDS), NHS Business Services Authority (NHSBSA)
[20 words unchanged]
the criteria within the latest specification as provided by University of Oxford.*
• NHS
Digital
England
will then remove any records where a national data opt-out has been
[22 words unchanged]
to ensure that patient information that might imply a location is protected.
[1 paragraph unchanged]
*NOTE: Although the HES APC and NHSBSA Medicines datasets are being cross-referenced
[63 words unchanged]
Medicines data is covered under a separate Data Processing Agreement between NHS
Digital
England
and University of Oxford
[1 paragraph unchanged]
• Each time NHS
Digital
England
create and disseminate an extract, the records will be added to a mailing list cohort dataset, including individual participant IDs.
[1 paragraph unchanged]
• NHS
Digital
England
will provide Paragon Customer Communications with Forename, Surname, Address, Postcode and Unique barcode reference via SEFT.
[2 paragraphs unchanged]
• Paragon Customer Communications will destroy all data received from NHS
Digital
England
30 days after mailing as instructed by the University of Oxford.
[1 paragraph unchanged]
The invitation letter is mailed with an enclosed Initial Information Leaflet, a
[148 words unchanged]
NHS number, date of birth, gender and GP practice details from NHS
Digital,
England,
so that the study team can complete the screening assessment, and, if
[51 words unchanged]
Oxford to make further contact is clearly described on the reply form.
[1 paragraph unchanged]
On a weekly basis, the University of Oxford will securely provide NHS
Digital
England
with the unique identifiers (barcode reference) for all those individuals who have returned their reply form. NHS
Digital
England
will use the unique barcode reference to link back to the potential
[20 words unchanged]
data items will be returned securely to University of Oxford via SEFT.
[2 paragraphs unchanged]
On an ad-hoc basis (up to once a week), NHS
Digital
England
will compare the cohort of invitees to the cohort of interested participants
[56 words unchanged]
Data Access Requested) as “Customer – Data Quality Report – Aggregate (Communications)”
The permitted territory of use for data provided by NHS
Digital
England
for this agreement is UK.
[1 paragraph unchanged]
An aggregate report with small numbers supressed (as per the HES Analysis
[10 words unchanged]
the mailing cohort will be provided to University of Oxford from NHS
Digital
England
for the purposes of confirming that inclusion and exclusion criteria have been
[49 words unchanged]
should not be disseminated, such as those on a witness protection programme.
The data from NHS
Digital
England
will not be used for any other purpose other than that outlined in this Agreement. The data from NHS
Digital
England
will not be linked to any other data other than those outlined in this Agreement.
[7 paragraphs unchanged]
Expected output
[1 paragraph unchanged]
Identifiable health data requested from NHS
Digital
England
will only be used to identify and invite potential participants. NHS
Digital
England
record Level Identifiable data will only be available to University of Oxford after participants have expressed interest and returned the consenting reply form.
[4 paragraphs unchanged]
Benefits reported
Not stated in the previous version; added here.
This Data Sharing Agreement with NHS England has enabled effective and fast recruitment of participants into the ASCEND PLUS clinical trial.
As of the week commencing 25th November 2024, ASCEND PLUS has screened 20,000 participants, 15,000 have entered the run-in period, and 9,200 have been randomised. This has been achieved over just 18-months (excepting a very small initial mailing). Compared to the original ASCEND trial (also a mail-based study), recruitment to ASCEND PLUS has been 2 to 3 times faster.
Unchanged: Expected measurable benefits.
DARS-NIC-655024-S2H5Q-v1.2 27 January 2023 to 6 December 2024
- Title
- A Study of Cardiovascular Events iN Diabetes – PLUS (ASCEND PLUS) - Recruitment agreement
- Commercial
- Yes
- Sublicensing
- No
- Datasets
- 4
- Files released
- 0
Datasets: Customer - Data Quality Report - Aggregate (Comms); Customer - Data Quality Report - Aggregate (Recruitment); Demographics; Mailing - Cohort - Non-aggregate (Comms & Recruitment)
What changed from DARS-NIC-655024-S2H5Q-v0.5
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2023-01-27 | |
| Mailing - Cohort - Non-aggregate (Comms & Recruitment): legal basis | Health and Social Care Act 2012 - s261(2)(d); National Health Service Act 2006 - s251 - 'Control of patient information'. |
Objective for processing
[23 paragraphs unchanged] For the first element of the recruitment process, the legal basis for the identifiable data from NHS Digital to flow to Paragon Customer Communications Ltd (Paragon CC) for the purpose of University of Oxford inviting them to join the [5 words unchanged] 251 approval (NHS Act 2006), approved by the Confidentiality Advisory Group (CAG). [53 paragraphs unchanged] ***ADDITION OF A DATA PROCESSOR - Version 1 of this agreement - January 2023*** Atos IT services UK Limited - Paragon Customer Communications are shortly to sign a contract with Atos IT services Limited as a sub-processor who would also store and process NHS Digital data. Therefore, in anticipation of this contract being signed, this data sharing agreement has been uplifted to include Atos IT services UK Limited as a data processor. Atos IT services UK Limited has been appointed to provide various services under the Managed IT services contract from Paragon CC. These are listed below. Under each service banner Atos IT services UK Limited pre-vetted resources will have access to Paragon's IT estate in order to deliver the required support and services. In some cases, Atos IT services UK Limited resources will have direct or indirect access to client data. 1. Service desk and IT service management 2. Hosting and networks infrastructure 3. End user compute 4. Application development, support and maintenance 5. Information security services Whilst the data will remain resident onshore in UK data centres only, there may be instances where data may be viewed by authorised Atos IT services UK Limited employees from outside the UK and EU, but this is on a read-only basis and there are processes in place so files/data cannot be downloaded to the employee’s location. ********************************* [3 paragraphs unchanged]
Processing activities
[1 paragraph unchanged]
NHS Digital would be using a mailing
provider (Paragon
provider, Paragon
Customer
Communications)
Communications Ltd (and by association its contracted sub-processor Atos IT services UK Limited),
to fulfil the communications. Paragon Customer Communications
Ltd
will use Research Ethics Committee (REC)-approved template invitation letters and would add
[42 words unchanged]
Advisory Group (CAG) for this element of the ASCEND PLUS trial recruitment.
[13 paragraphs unchanged]
*NOTE: Although the HES APC and NHSBSA Medicines datasets are being cross-referenced
[32 words unchanged]
data will be shared with either University of Oxford or Paragon Customer
Communications.
Communications (or by association its contracted sub-processor Atos IT services UK Limited).
The processing of HES APC and NHSBSA Medicines data is covered under a separate Data Processing Agreement between NHS Digital and University of Oxford
[14 paragraphs unchanged]
The permitted territory of use for data provided by NHS Digital for this agreement is
England and Wales.
UK.
[10 paragraphs unchanged]
Benefits reported
Stated in the previous version and removed here.
Yielded Benefits is not a requirement for new applications.
Unchanged: Expected output, Expected measurable benefits.
Objective for processing
BACKGROUND
Around one in 11 adults worldwide has diabetes: a long-term condition where a person’s blood sugar levels are too high.
There are two main types of diabetes:
• Type 1 diabetes – where the body’s immune system attacks and destroys the cells that produce the hormone insulin so that no insulin is produced. This is treated with insulin injections.
• Type 2 diabetes – where the body does not produce enough insulin, or the body’s cells do not react to insulin. This usually occurs later in life and is often treated with tablets. Some patients eventually need to be treated with insulin.
People with diabetes are more likely to suffer from other major health problems. These include heart and circulatory problems (including heart attacks and strokes), high blood pressure and dementia. Diabetes can cause kidney disease, problems with feeling in the feet, and eye problems that may affect vision.
ASCEND PLUS is a clinical trial led by the University of Oxford. It is a randomised, double-blind, parallel-group, placebo-controlled event driven trial designed to test the hypothesis that oral semaglutide reduces cardiovascular events and other complications of diabetes in people with type 2 diabetes mellitus (T2DM) without a prior heart attack or stroke. The study will use streamlined methodology to randomise approximately 20,000 people with T2DM in the UK and follow them during a scheduled treatment period with a median duration of approximately 5 years.
OUTCOMES DATA (Not part of this agreement however for future information)
With consent, the ASCEND PLUS team will collect linked healthcare data from NHS Digital and other organisations for the 5-year scheduled treatment period and the following 20 years in order to find out the medium and long-term effects of oral semaglutide (this linkage for consented trial participants will be covered by a separate Data Sharing Agreement).
THE AIM OF THE TRIAL
The ASCEND PLUS trial aims to provide evidence about both the efficacy and safety of prolonged treatment with oral semaglutide. The hypothesis of the ASCEND PLUS trial is that treatment with oral semaglutide reduces cardiovascular events and other complications of diabetes in individuals aged at least 55 years, with T2DM, without a history of a heart attack or stroke, and without any upper or lower Haemoglobin A1c (HbA1c) threshold.
STUDY TEAM
Any reference to "the study team" in this agreement refers to members staff substantively employed by University of Oxford directly working on the ASCEND PLUS programme.
PATIENT AND PUBLIC INVOLVEMENT AND ENGAGEMENT (PPIE)
Two lay members were recruitment to the trial Steering Committee (TSC) and attended the first TSC meeting in June 2021 and subsequent meetings, ensuring patient and public involvement in the high-level strategic decisions for the trial.
Between June and October 2021, the ASCEND PLUS team convened six patient and public focus groups, largely involving people with type 2 diabetes. The groups included people from diverse backgrounds across the UK, with the exception of Northern Ireland, as the trial will not take place in this location. The trial’s proposed consent model formed a key focus of each group. There was strong support for potential trial participants to have a choice of consent method (self-directed online consent or consent via nurse telephone or video call interview). The trial procedures were amended in light of the advice from these groups to offer this choice within the reply form. The use of patient data without consent (to invite patients to join the study) formed a focus of the group discussions at 5 of the meetings. There was broad support for this process to enable the study to recruit the large number of participants required.
The trial has convened the ASCEND PLUS Public Advisory Group (ASCEND PAG), a diverse group of patients and public, to input into the whole life-cycle of the trial. Members were recruited from the existing Nuffield Department of Population Health public advisory panel and the focus groups described above. The ASCEND PAG give feedback, advice and opinions across different aspects of the trial including recruitment materials, participant questionnaires, website development, strategies to maintain participant adherence and engagement, and dissemination of the trial results. The first meeting was held on 6 September 2021. Group members have subsequently provided input into all the patient-facing trial documents. As a result of feedback from the ASCEND PAG and the focus groups, the material was divided into three leaflets; an initial information leaflet to be sent out with the invitation letter and then a full participant information leaflet and a separate data protection leaflet, which are to be sent to individuals who express an interest in the trial. Text and content change recommendations from ASCEND PAG members were implemented throughout, unless these were inconsistent with the study processes.
This has resulted in documents which are easier to understand and more inclusive. For example, for the invitation letter, ASCEND PAG members edited the transparency notice wording to plain English and added the text box, ‘If you would like this information in a non-English language or other format, such as large print, please contact us’ to the start of the invitation letter. In other places, the ASCEND PAG requested a change to the order of the information presented. For example in the participant information leaflet the section, ‘Will taking part affect my medical insurance or travelling?’ was moved earlier in the document.
The ASCEND PAG also co-developed the consent animation, which is part of the self-directed online consent process. First they contributed to the development of the script and then provided feedback on the images used in the storyboard, most of which were implemented. The ASCEND PAG was also instrumental in the selection of which quality of life questionnaires to include in the protocol and have reviewed the draft screening form questions and provided detailed feedback.
To optimise the wording for the letter invites, NHS DigiTrials team in NHS Digital have tested different letter variants with members of the public. Initially, NHS DigiTrials conducted desk research and developed hypotheses on behavioural techniques that would help optimise invitation letters.
NHS DigiTrials analysed the results and focussed on people with Type II Diabetes in order to help inform invites for the ASCEND PLUS trial. For people with this health condition, all experimental letter variants outperformed the control on all reported measures of taking action. As a result of this, the content of the invitation letters for the ASCEND PLUS trial may be amended slightly to align with the optimum performing letters from the testing
LEGAL BASIS FOR COMMON LAW DUTY OF CONFIDENTIALITY
University of Oxford as data controller, are requesting to use NHS Digital data to support a clinical trial called ASCEND PLUS. This agreement is specifically to support the recruitment of a cohort by writing out to individuals who meet the required eligibility criteria.
For the first element of the recruitment process, the legal basis for the identifiable data from NHS Digital to flow to Paragon Customer Communications Ltd (Paragon CC) for the purpose of University of Oxford inviting them to join the ASCEND PLUS trial is Section 251 approval (NHS Act 2006), approved by the Confidentiality Advisory Group (CAG).
For the second element of the recruitment process, the University of Oxford are relying on consent. Interested potential participants will return a reply form to University of Oxford which will include consent to obtain participant information. Further details on this are detailed within Processing Activities section.
GDPR LEGAL BASIS FOR PROCESSING OF PERSONAL DATA
University of Oxford, as sole Data Controller, are using Article 6(1)(e) "processing is necessary for the performance of a task in the public interest or in the exercise of official authority vested in the controller." As part of the application process, the requirement for the data requested has been assessed and NHS Digital is content that it is appropriate, necessary and proportionate for the performance of the task described in the purpose statement and that there is no other reasonable and less intrusive means for the data processor to achieve their purpose.
It is acknowledged that University of Oxford has no direct relationship with the potential research participants up until the time (if they choose to) they respond to the postal invitation by returning the reply form to University of Oxford. At that point, University of Oxford relies on the potential research participant’s consent to
A) obtain participant identifiable information from NHS Digital, and
B) issue the participant with more information regarding the trial and make contact to undergo trial screening and solicit consent to participate in the trial.
Potential participants may experience minor inconvenience of being contacted and invited to take part in the research programme. However, the inconvenience is restricted to the receipt of a letter through the post. Therefore, the likelihood of any adverse impact on the data subjects is low and the severity of any such impact is judged to be minimal.
Additionally (as health data is a special category of Personal Data), University of Oxford is using Article 9(2)(j): Special category data used for “Archiving in the public interest, scientific or historical research or statistical purposes”. If the Study Team demonstrate that oral semaglutide is beneficial in a wide range of patients with type 2 diabetes then the results could change national and international guidelines and more patients could be offered the treatment. This should reduce the risk of complications in patients with diabetes which is in the interest of the public.
INCLUSION AND EXCLUSION CRITERIA FOR INVITATION
The trial will be conducted throughout the UK* and the aim is to recruit a total of 20,000 participants. It is anticipated that about 18,000 of these participants will be recruitment through the collaboration with NHS Digital in England but this may change as the trial recruitment progresses.
Lists of potentially eligible individuals will be generated from electronic searches of centrally held NHS datasets at NHS Digital
*NOTE: NHS Digital will be providing data for England only. The study will be obtaining the related data from the other devolved nations from the relevant organisations.
Invitation inclusion criteria:
• Reside within England
• Age at least 55 years (this is to ensure that the individuals taking part in the trial are at sufficiently high risk of the relevant cardiovascular disease outcomes (e.g. heart attack and stroke).
• Have type 2 diabetes (based on either a relevant diabetes ICD-10 code in their Hospital Episode Statistics data and/or receipt of diabetes treatment in the NHSBSA Medicines data)
Invitation exclusion criteria:
The overall cohort of participant aims to be representative across UK geographical locations, age, and gender. It is possible as part of the creation of each NHS Digital mailout, that specific criteria will be applied to the searches to create the invitee list for that mailout. This may involve increasing the proportion of invitees from particular criteria groups to facilitate balancing the overall cohort make up.
In addition, participants should not have a recorded history of heart attack, stroke, recent cancer or dementia.
Recruitment is expected to begin around December 2022 and take place over 2 years. For the first year of recruitment, approximately half a million patients will be identified and contacted. With an assumed response through to randomisation rate of 2%- , approximately 9,000 patients should be recruited, however this recruitment target is an estimate and may be subject to change. The study team anticipate that a further half million invites will be required in the second year, however, should the study team require a substantial change to the recruitment target or number of invitees, an amendment to this agreement will be required with justification for the change, with appropriate Ethics and CAG approval.
REQUESTING NOT TO TAKE PART IN THE PROGRAMME:
In addition to the National Data Opt-out, members of the public will be able to specifically request not to be contacted for the ASCEND PLUS trial. University of Oxford will promote this information via the dedicated programme website (http://www.ascend-plus-trial.org) and via local media for two weeks prior to letters being issued to enable those who do not wish to receive a letter to declare this. NHS Digital will also promote this information via a dedicated page on its website (http://digital.nhs.uk/ascend-plus). There will also be an option for people to register their request not to take part in ASCEND plus by telephone. In order to provide a single point of contact for all trial related queries, individuals who do not want to be contacted for ASCEND PLUS but are unable to access the study-specific opt-out form on the NHS Digital website will be asked to call the trial Freephone number at the University of Oxford. The trained switchboard team will then record the study specific opt-out on the NHS Digital website on the individuals behalf with no personal data entered into the University of Oxford systems.
NHS Digital will ensure that anyone who has registered for the study specific opt-out will be excluded from the cohort selection and as a result their details will not be on the list passed to Paragon CC for invitations to be sent.
MAILOUTS
Potential participant will be sent one invitation for the ASCEND PLUS trial unless any of the following criteria apply:
1. A national data opt-out has been applied
2. A trial specific opt-out has been applied
Each letter will be mailed with a reply form and the Initial Information Leaflet.
ORGANISATION’S ROLES AND RESPONSIBILITIES:
University of Oxford is the applicant and data controller, who also process data. They are responsible for the programme and overseeing the work carried out to aid recruitment into the programme. They are also responsible for providing the core eligibility criteria for participants.
University of Oxford are responsible for:
1. Generating the invitation request(s) and sending to NHS Digital on a regular basis
2. Monitoring uptake by invitees (i.e. numbers of invitees consenting to participate in the programme)
3. Monitoring scope of the population sending back reply forms
4. Adjusting the selection criteria for invitations to adjust for underrepresentation of target populations taking up the programme, as necessary.
5. Compiling weekly cohorts of interested participants (from the returned reply forms) and securely transferring to NHS Digital for linkage with further participant identifiers and vital status.
NHS Digital are acting as a data processor on behalf of University of Oxford and are responsible for:
1. Applying the inclusion and exclusion criteria to NHS Digital Datasets to generate a list of invitees
2. Feeding back to University of Oxford the number of invitees actually fulfilled out of the total target population, via an aggregate report with small numbers suppressed.
3. Removing objections or opt outs (where a national data opt-out has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.)
4. Sending the list of invitees on to University of Oxford's third-party provider (Paragon Customer Communications Ltd) for generating the invitation letters and mailing these out
5. Agreeing with University of Oxford key processing timelines, including
a. Time from submission to Paragon Customer Communications to mailout
b. Date of the mail outs
c. Daily cut-off times (i.e. after which processing will take place the next day)
d. Time to feedback to University of Oxford the numbers selected
6. Where the number of invitees is less than the population available, invoking a system to choose invitees at random
7. Maintaining a record of people who have returned reply forms to University of Oxford (details of which University of Oxford will supply to NHS Digital securely via Secure Electronic File Transfer (SEFT) and ensuring that these participants are excluded from a second or any further rounds of invitations.
8. Maintaining a record of people invited to the study ensuring they are excluded from any further rounds of invitations.
9. Processing the cohort of interested participants (approximately on a weekly basis) and providing vital status update and updated cohort information securely back to University of Oxford.
10. Processing the cohort of interested participants (on an ad-hoc basis) against the cohort of invitees to produce an aggregate recruitment conversion report, with small numbers suppressed. This report is to be securely shared with University of Oxford.
Paragon Customer Communications are acting as a processor of University of Oxford. Their responsibility is to receive the lists of invitees from NHS Digital and mail out to them accordingly.
A 'return to sender' address will need to be included on the letters. When letters are unable to be delivered to the participant address provided by NHS Digital - they will be returned to Paragon Customer Communications where they will be shredded. Paragon Customer Communications will provide University of Oxford with an aggregate report of number of returned letters.
***ADDITION OF A DATA PROCESSOR - Version 1 of this agreement - January 2023***
Atos IT services UK Limited - Paragon Customer Communications are shortly to sign a contract with Atos IT services Limited as a sub-processor who would also store and process NHS Digital data. Therefore, in anticipation of this contract being signed, this data sharing agreement has been uplifted to include Atos IT services UK Limited as a data processor.
Atos IT services UK Limited has been appointed to provide various services under the Managed IT services contract from Paragon CC. These are listed below. Under each service banner Atos IT services UK Limited pre-vetted resources will have access to Paragon's IT estate in order to deliver the required support and services. In some cases, Atos IT services UK Limited resources will have direct or indirect access to client data.
1. Service desk and IT service management
2. Hosting and networks infrastructure
3. End user compute
4. Application development, support and maintenance
5. Information security services
Whilst the data will remain resident onshore in UK data centres only, there may be instances where data may be viewed by authorised Atos IT services UK Limited employees from outside the UK and EU, but this is on a read-only basis and there are processes in place so files/data cannot be downloaded to the employee’s location.
*********************************
FUNDING and COMMERCIAL PURPOSE.
The ASCEND PLUS trial was initiated and designed by investigators at the University of Oxford aiming to improve the health of people with type 2 diabetes. The trial is funded through a grant to the University of Oxford from Novo Nordisk, a Danish multinational pharmaceutical company. Additionally, Novo Nordisk - who manufacture the treatment being studied, oral semaglutide - will also be providing the study treatment for the trial. Oral semaglutide is the only oral medication in this class. There are other drugs in this class produced by other companies, however these are given by injection so would not be suitable for the ASCEND PLUS trial design and may be more difficult for patients to take. This is why the study team approached Novo Nordisk rather than any other manufacturer for this study. In the interests of transparency, it is stated here that if the results show that oral semaglutide is beneficial for a wide range of people with diabetes, then this could also increase revenue for the manufacturer Novo Nordisk. Nordisk will have no influence over any of the findings and will have no ability to suppress any outputs produced by the study.
NHS Digital record level data covered by this Data Sharing Agreement will not be shared with any funders and final decision making on processing of the data rests with University of Oxford senior trial management team who are all substantive employees, therefore the funders are not considered Data Controllers or Data Processors on this agreement. The ASCEND PLUS study is sponsored by The University of Oxford. The protocol and procedures have been developed by the investigators at the Clinical Trial Service Unit, University of Oxford with contributions from Novo Nordisk. The Steering Committee determine the scientific objectives of the trial, ensure adequate progress towards those objectives and review any papers prior to publication. As is usual with this type of trial, the Steering Committee has representatives from the funder and also has other experts from other institutions to advise the trial management team. The Steering Group will not have access to or process any NHS Digital record-level Data.
Expected output
As a result of this recruitment agreement with NHS DigiTrials, the ASCEND plus study team are hoping to recruit to target having posted out adequate numbers of invitations to potentially eligible participants.
Identifiable health data requested from NHS Digital will only be used to identify and invite potential participants. NHS Digital record Level Identifiable data will only be available to University of Oxford after participants have expressed interest and returned the consenting reply form.
Progress against recruitment targets may be reported to the University of Oxford, the funder Novo Nordisk and the Trials Steering Committee in an aggregated and suppressed format.
Key recruitment targets have been set for first year of recruitment and will be closely monitored and reported. NHS DigiTrials forms the main route to recruitment for the trial and the sole method of recruitment in England.
Successful recruitment will enable to trial to test the effects of oral semaglutide in a wide range of people with type diabetes. The main results of the trial are expected in 2028 and should inform National and International guidelines. Examples of these guidelines could include the NICE guideline on “Type 2 diabetes in adults: management”, the American Diabetes Association Standards of Medical Care in Diabetes guidelines and the diabetes guidelines from the European Society of Cardiology and the European Association for the Study of Diabetes. The study team aim to publish the main trail report in a high-impact medical journal with a public summary on the trial website.
Results will also be communicated directly to trial participants.
DARS-NIC-655024-S2H5Q-v0.5 7 December 2022 to 6 December 2024
- Title
- A Study of Cardiovascular Events iN Diabetes – PLUS (ASCEND PLUS) - Recruitment agreement
- Commercial
- Yes
- Sublicensing
- No
- Datasets
- 4
- Files released
- 0
Datasets: Customer - Data Quality Report - Aggregate (Comms); Customer - Data Quality Report - Aggregate (Recruitment); Demographics; Mailing - Cohort - Non-aggregate (Comms & Recruitment)
Objective for processing
BACKGROUND
Around one in 11 adults worldwide has diabetes: a long-term condition where a person’s blood sugar levels are too high.
There are two main types of diabetes:
• Type 1 diabetes – where the body’s immune system attacks and destroys the cells that produce the hormone insulin so that no insulin is produced. This is treated with insulin injections.
• Type 2 diabetes – where the body does not produce enough insulin, or the body’s cells do not react to insulin. This usually occurs later in life and is often treated with tablets. Some patients eventually need to be treated with insulin.
People with diabetes are more likely to suffer from other major health problems. These include heart and circulatory problems (including heart attacks and strokes), high blood pressure and dementia. Diabetes can cause kidney disease, problems with feeling in the feet, and eye problems that may affect vision.
ASCEND PLUS is a clinical trial led by the University of Oxford. It is a randomised, double-blind, parallel-group, placebo-controlled event driven trial designed to test the hypothesis that oral semaglutide reduces cardiovascular events and other complications of diabetes in people with type 2 diabetes mellitus (T2DM) without a prior heart attack or stroke. The study will use streamlined methodology to randomise approximately 20,000 people with T2DM in the UK and follow them during a scheduled treatment period with a median duration of approximately 5 years.
OUTCOMES DATA (Not part of this agreement however for future information)
With consent, the ASCEND PLUS team will collect linked healthcare data from NHS Digital and other organisations for the 5-year scheduled treatment period and the following 20 years in order to find out the medium and long-term effects of oral semaglutide (this linkage for consented trial participants will be covered by a separate Data Sharing Agreement).
THE AIM OF THE TRIAL
The ASCEND PLUS trial aims to provide evidence about both the efficacy and safety of prolonged treatment with oral semaglutide. The hypothesis of the ASCEND PLUS trial is that treatment with oral semaglutide reduces cardiovascular events and other complications of diabetes in individuals aged at least 55 years, with T2DM, without a history of a heart attack or stroke, and without any upper or lower Haemoglobin A1c (HbA1c) threshold.
STUDY TEAM
Any reference to "the study team" in this agreement refers to members staff substantively employed by University of Oxford directly working on the ASCEND PLUS programme.
PATIENT AND PUBLIC INVOLVEMENT AND ENGAGEMENT (PPIE)
Two lay members were recruitment to the trial Steering Committee (TSC) and attended the first TSC meeting in June 2021 and subsequent meetings, ensuring patient and public involvement in the high-level strategic decisions for the trial.
Between June and October 2021, the ASCEND PLUS team convened six patient and public focus groups, largely involving people with type 2 diabetes. The groups included people from diverse backgrounds across the UK, with the exception of Northern Ireland, as the trial will not take place in this location. The trial’s proposed consent model formed a key focus of each group. There was strong support for potential trial participants to have a choice of consent method (self-directed online consent or consent via nurse telephone or video call interview). The trial procedures were amended in light of the advice from these groups to offer this choice within the reply form. The use of patient data without consent (to invite patients to join the study) formed a focus of the group discussions at 5 of the meetings. There was broad support for this process to enable the study to recruit the large number of participants required.
The trial has convened the ASCEND PLUS Public Advisory Group (ASCEND PAG), a diverse group of patients and public, to input into the whole life-cycle of the trial. Members were recruited from the existing Nuffield Department of Population Health public advisory panel and the focus groups described above. The ASCEND PAG give feedback, advice and opinions across different aspects of the trial including recruitment materials, participant questionnaires, website development, strategies to maintain participant adherence and engagement, and dissemination of the trial results. The first meeting was held on 6 September 2021. Group members have subsequently provided input into all the patient-facing trial documents. As a result of feedback from the ASCEND PAG and the focus groups, the material was divided into three leaflets; an initial information leaflet to be sent out with the invitation letter and then a full participant information leaflet and a separate data protection leaflet, which are to be sent to individuals who express an interest in the trial. Text and content change recommendations from ASCEND PAG members were implemented throughout, unless these were inconsistent with the study processes.
This has resulted in documents which are easier to understand and more inclusive. For example, for the invitation letter, ASCEND PAG members edited the transparency notice wording to plain English and added the text box, ‘If you would like this information in a non-English language or other format, such as large print, please contact us’ to the start of the invitation letter. In other places, the ASCEND PAG requested a change to the order of the information presented. For example in the participant information leaflet the section, ‘Will taking part affect my medical insurance or travelling?’ was moved earlier in the document.
The ASCEND PAG also co-developed the consent animation, which is part of the self-directed online consent process. First they contributed to the development of the script and then provided feedback on the images used in the storyboard, most of which were implemented. The ASCEND PAG was also instrumental in the selection of which quality of life questionnaires to include in the protocol and have reviewed the draft screening form questions and provided detailed feedback.
To optimise the wording for the letter invites, NHS DigiTrials team in NHS Digital have tested different letter variants with members of the public. Initially, NHS DigiTrials conducted desk research and developed hypotheses on behavioural techniques that would help optimise invitation letters.
NHS DigiTrials analysed the results and focussed on people with Type II Diabetes in order to help inform invites for the ASCEND PLUS trial. For people with this health condition, all experimental letter variants outperformed the control on all reported measures of taking action. As a result of this, the content of the invitation letters for the ASCEND PLUS trial may be amended slightly to align with the optimum performing letters from the testing
LEGAL BASIS FOR COMMON LAW DUTY OF CONFIDENTIALITY
University of Oxford as data controller, are requesting to use NHS Digital data to support a clinical trial called ASCEND PLUS. This agreement is specifically to support the recruitment of a cohort by writing out to individuals who meet the required eligibility criteria.
For the first element of the recruitment process, the legal basis for the identifiable data from NHS Digital to flow to Paragon Customer Communications Ltd for the purpose of University of Oxford inviting them to join the ASCEND PLUS trial is Section 251 approval (NHS Act 2006), approved by the Confidentiality Advisory Group (CAG).
For the second element of the recruitment process, the University of Oxford are relying on consent. Interested potential participants will return a reply form to University of Oxford which will include consent to obtain participant information. Further details on this are detailed within Processing Activities section.
GDPR LEGAL BASIS FOR PROCESSING OF PERSONAL DATA
University of Oxford, as sole Data Controller, are using Article 6(1)(e) "processing is necessary for the performance of a task in the public interest or in the exercise of official authority vested in the controller." As part of the application process, the requirement for the data requested has been assessed and NHS Digital is content that it is appropriate, necessary and proportionate for the performance of the task described in the purpose statement and that there is no other reasonable and less intrusive means for the data processor to achieve their purpose.
It is acknowledged that University of Oxford has no direct relationship with the potential research participants up until the time (if they choose to) they respond to the postal invitation by returning the reply form to University of Oxford. At that point, University of Oxford relies on the potential research participant’s consent to
A) obtain participant identifiable information from NHS Digital, and
B) issue the participant with more information regarding the trial and make contact to undergo trial screening and solicit consent to participate in the trial.
Potential participants may experience minor inconvenience of being contacted and invited to take part in the research programme. However, the inconvenience is restricted to the receipt of a letter through the post. Therefore, the likelihood of any adverse impact on the data subjects is low and the severity of any such impact is judged to be minimal.
Additionally (as health data is a special category of Personal Data), University of Oxford is using Article 9(2)(j): Special category data used for “Archiving in the public interest, scientific or historical research or statistical purposes”. If the Study Team demonstrate that oral semaglutide is beneficial in a wide range of patients with type 2 diabetes then the results could change national and international guidelines and more patients could be offered the treatment. This should reduce the risk of complications in patients with diabetes which is in the interest of the public.
INCLUSION AND EXCLUSION CRITERIA FOR INVITATION
The trial will be conducted throughout the UK* and the aim is to recruit a total of 20,000 participants. It is anticipated that about 18,000 of these participants will be recruitment through the collaboration with NHS Digital in England but this may change as the trial recruitment progresses.
Lists of potentially eligible individuals will be generated from electronic searches of centrally held NHS datasets at NHS Digital
*NOTE: NHS Digital will be providing data for England only. The study will be obtaining the related data from the other devolved nations from the relevant organisations.
Invitation inclusion criteria:
• Reside within England
• Age at least 55 years (this is to ensure that the individuals taking part in the trial are at sufficiently high risk of the relevant cardiovascular disease outcomes (e.g. heart attack and stroke).
• Have type 2 diabetes (based on either a relevant diabetes ICD-10 code in their Hospital Episode Statistics data and/or receipt of diabetes treatment in the NHSBSA Medicines data)
Invitation exclusion criteria:
The overall cohort of participant aims to be representative across UK geographical locations, age, and gender. It is possible as part of the creation of each NHS Digital mailout, that specific criteria will be applied to the searches to create the invitee list for that mailout. This may involve increasing the proportion of invitees from particular criteria groups to facilitate balancing the overall cohort make up.
In addition, participants should not have a recorded history of heart attack, stroke, recent cancer or dementia.
Recruitment is expected to begin around December 2022 and take place over 2 years. For the first year of recruitment, approximately half a million patients will be identified and contacted. With an assumed response through to randomisation rate of 2%- , approximately 9,000 patients should be recruited, however this recruitment target is an estimate and may be subject to change. The study team anticipate that a further half million invites will be required in the second year, however, should the study team require a substantial change to the recruitment target or number of invitees, an amendment to this agreement will be required with justification for the change, with appropriate Ethics and CAG approval.
REQUESTING NOT TO TAKE PART IN THE PROGRAMME:
In addition to the National Data Opt-out, members of the public will be able to specifically request not to be contacted for the ASCEND PLUS trial. University of Oxford will promote this information via the dedicated programme website (http://www.ascend-plus-trial.org) and via local media for two weeks prior to letters being issued to enable those who do not wish to receive a letter to declare this. NHS Digital will also promote this information via a dedicated page on its website (http://digital.nhs.uk/ascend-plus). There will also be an option for people to register their request not to take part in ASCEND plus by telephone. In order to provide a single point of contact for all trial related queries, individuals who do not want to be contacted for ASCEND PLUS but are unable to access the study-specific opt-out form on the NHS Digital website will be asked to call the trial Freephone number at the University of Oxford. The trained switchboard team will then record the study specific opt-out on the NHS Digital website on the individuals behalf with no personal data entered into the University of Oxford systems.
NHS Digital will ensure that anyone who has registered for the study specific opt-out will be excluded from the cohort selection and as a result their details will not be on the list passed to Paragon CC for invitations to be sent.
MAILOUTS
Potential participant will be sent one invitation for the ASCEND PLUS trial unless any of the following criteria apply:
1. A national data opt-out has been applied
2. A trial specific opt-out has been applied
Each letter will be mailed with a reply form and the Initial Information Leaflet.
ORGANISATION’S ROLES AND RESPONSIBILITIES:
University of Oxford is the applicant and data controller, who also process data. They are responsible for the programme and overseeing the work carried out to aid recruitment into the programme. They are also responsible for providing the core eligibility criteria for participants.
University of Oxford are responsible for:
1. Generating the invitation request(s) and sending to NHS Digital on a regular basis
2. Monitoring uptake by invitees (i.e. numbers of invitees consenting to participate in the programme)
3. Monitoring scope of the population sending back reply forms
4. Adjusting the selection criteria for invitations to adjust for underrepresentation of target populations taking up the programme, as necessary.
5. Compiling weekly cohorts of interested participants (from the returned reply forms) and securely transferring to NHS Digital for linkage with further participant identifiers and vital status.
NHS Digital are acting as a data processor on behalf of University of Oxford and are responsible for:
1. Applying the inclusion and exclusion criteria to NHS Digital Datasets to generate a list of invitees
2. Feeding back to University of Oxford the number of invitees actually fulfilled out of the total target population, via an aggregate report with small numbers suppressed.
3. Removing objections or opt outs (where a national data opt-out has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.)
4. Sending the list of invitees on to University of Oxford's third-party provider (Paragon Customer Communications Ltd) for generating the invitation letters and mailing these out
5. Agreeing with University of Oxford key processing timelines, including
a. Time from submission to Paragon Customer Communications to mailout
b. Date of the mail outs
c. Daily cut-off times (i.e. after which processing will take place the next day)
d. Time to feedback to University of Oxford the numbers selected
6. Where the number of invitees is less than the population available, invoking a system to choose invitees at random
7. Maintaining a record of people who have returned reply forms to University of Oxford (details of which University of Oxford will supply to NHS Digital securely via Secure Electronic File Transfer (SEFT) and ensuring that these participants are excluded from a second or any further rounds of invitations.
8. Maintaining a record of people invited to the study ensuring they are excluded from any further rounds of invitations.
9. Processing the cohort of interested participants (approximately on a weekly basis) and providing vital status update and updated cohort information securely back to University of Oxford.
10. Processing the cohort of interested participants (on an ad-hoc basis) against the cohort of invitees to produce an aggregate recruitment conversion report, with small numbers suppressed. This report is to be securely shared with University of Oxford.
Paragon Customer Communications are acting as a processor of University of Oxford. Their responsibility is to receive the lists of invitees from NHS Digital and mail out to them accordingly.
A 'return to sender' address will need to be included on the letters. When letters are unable to be delivered to the participant address provided by NHS Digital - they will be returned to Paragon Customer Communications where they will be shredded. Paragon Customer Communications will provide University of Oxford with an aggregate report of number of returned letters.
FUNDING and COMMERCIAL PURPOSE.
The ASCEND PLUS trial was initiated and designed by investigators at the University of Oxford aiming to improve the health of people with type 2 diabetes. The trial is funded through a grant to the University of Oxford from Novo Nordisk, a Danish multinational pharmaceutical company. Additionally, Novo Nordisk - who manufacture the treatment being studied, oral semaglutide - will also be providing the study treatment for the trial. Oral semaglutide is the only oral medication in this class. There are other drugs in this class produced by other companies, however these are given by injection so would not be suitable for the ASCEND PLUS trial design and may be more difficult for patients to take. This is why the study team approached Novo Nordisk rather than any other manufacturer for this study. In the interests of transparency, it is stated here that if the results show that oral semaglutide is beneficial for a wide range of people with diabetes, then this could also increase revenue for the manufacturer Novo Nordisk. Nordisk will have no influence over any of the findings and will have no ability to suppress any outputs produced by the study.
NHS Digital record level data covered by this Data Sharing Agreement will not be shared with any funders and final decision making on processing of the data rests with University of Oxford senior trial management team who are all substantive employees, therefore the funders are not considered Data Controllers or Data Processors on this agreement. The ASCEND PLUS study is sponsored by The University of Oxford. The protocol and procedures have been developed by the investigators at the Clinical Trial Service Unit, University of Oxford with contributions from Novo Nordisk. The Steering Committee determine the scientific objectives of the trial, ensure adequate progress towards those objectives and review any papers prior to publication. As is usual with this type of trial, the Steering Committee has representatives from the funder and also has other experts from other institutions to advise the trial management team. The Steering Group will not have access to or process any NHS Digital record-level Data.
Expected output
As a result of this recruitment agreement with NHS DigiTrials, the ASCEND plus study team are hoping to recruit to target having posted out adequate numbers of invitations to potentially eligible participants.
Identifiable health data requested from NHS Digital will only be used to identify and invite potential participants. NHS Digital record Level Identifiable data will only be available to University of Oxford after participants have expressed interest and returned the consenting reply form.
Progress against recruitment targets may be reported to the University of Oxford, the funder Novo Nordisk and the Trials Steering Committee in an aggregated and suppressed format.
Key recruitment targets have been set for first year of recruitment and will be closely monitored and reported. NHS DigiTrials forms the main route to recruitment for the trial and the sole method of recruitment in England.
Successful recruitment will enable to trial to test the effects of oral semaglutide in a wide range of people with type diabetes. The main results of the trial are expected in 2028 and should inform National and International guidelines. Examples of these guidelines could include the NICE guideline on “Type 2 diabetes in adults: management”, the American Diabetes Association Standards of Medical Care in Diabetes guidelines and the diabetes guidelines from the European Society of Cardiology and the European Association for the Study of Diabetes. The study team aim to publish the main trail report in a high-impact medical journal with a public summary on the trial website.
Results will also be communicated directly to trial participants.
Benefits reported
Yielded Benefits is not a requirement for new applications.
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.
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January 2023 —
first listed. 1 version: DARS-NIC-655024-S2H5Q-v0.5
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February 2023
1 version added: DARS-NIC-655024-S2H5Q-v1.2
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January 2025
1 version added: DARS-NIC-655024-S2H5Q-v2.2
Cite this page
NHS England (2026) Data Uses Register, September 2026 edition, agreement DARS-NIC-655024-S2H5Q, “A Study of Cardiovascular Events iN Diabetes – PLUS (ASCEND PLUS) - Recruitment agreement”. Read via NHS Data Access Explorer (unofficial), https://healthdatauses.uk/agreements/dars-nic-655024-s2h5q/ (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-655024-S2H5Q to see the original rows.