Expression of interest
NHS DigiTrials supports clinical trials and health research with services that support the development of new treatments to improve health and care.
The NHS DigiTrials Recruitment Service is a novel direct-to-patient recruitment model that has already delivered many benefits to clinical trials and complements existing recruitment mechanisms to increase the NHS’ ability to support and deliver clinical research.
Powered by NHS data, we identify potential participants who meet the eligibility criteria and invite them on behalf of the trial to take part.
Following the success of the trials that have used the DigiTrials Recruitment Service, we are excited to open applications for further trials planning to recruit in 2025/26, 2026/27 and 2027/28. Applications for 2025/26 will close 11 April 2025.
How to register your interest
Before applying, please read through the 'Before you apply' section below. This includes answers to questions we received about the Recruitment Service in the last round of applications.
Applications are made through an online form available at the bottom of this page. A PDF sample of the form is also available to download to support collaboration across applicant organisations. However, all applications will need to be submitted via the online form.
The application form will gather the information needed to identify:
- whether the Recruitment Service can support your trial
- whether your trial can support DigiTrials with our aims to further optimise the service
Due to the nature of health research some of the information required may be quite detailed, please make sure you allow enough time to complete the form.
If you have any questions that aren’t covered below, email: [email protected] with 'Recruitment - Expression of Interest query' in the subject line.
Before you apply
Check your trial is suitable for the Recruitment Service
The Recruitment Service is aimed primarily at clinical trials and healthcare research that meet the definition as set out in the UK Policy Framework for Health and Social Care Research. It must have support from Research Ethics Committee (REC) and Confidentiality Advisory Group (CAG) and be approved by the Health Research Authority. Throughout the application process ‘trial’ is used to cover any research that meets this definition.
Typical timelines
It can take around 3 to 4 months to progress a recruitment application after you have received CAG and REC support. This should be factored into your plan carefully for recruiting participants to your study or trial.
Research Ethics Committee (REC) approval | As determined by the Research Ethics Committee review - Health Research Authority |
S251 Confidentiality Advisory Group (CAG) approval | Dependent on CAG schedule and any work done to date by the trial |
Data Sharing Agreement (DSA) creation and review | 6 to 8 weeks after S251 and REC approval has been received |
Advisory Group on Data (AGD) review and NHS England approval | 2 to 3 weeks |
Invitations sent out | 4 weeks after the DSA is signed. This allows the required time for study specific opt-outs to be registered before invitations are sent |
You will need a Section 251
The Recruitment Service can only support research that would be eligible to receive Section 251 support as the legal basis for access to confidential patient information.
If you do not yet have Section 251 support, we can work with you to guide you through the application process. We can provide templated wording about the NHS DigiTrials recruitment service which you can use in your Section 251 application.
Trial feasibility
As part of assessing your application to use the Recruitment Service, we may check whether there are enough potential participants in the population to achieve the aims of the trial. This could be done using the DigiTrials Feasibility Self Service Tool using the trial inclusion and exclusion criteria.
If your application is successful, access to the Feasibility Self Service Tool will form part of the package. This will support you to identify the number of potential participants to invite across different geographical areas.
More information about the Feasibility Self Service Tool and how it can support research is available.
Recruitment Service costs
Every trial is different – from the number of invitations to be sent, to the complexity of the inclusion and exclusion criteria. An indication of the costs will be provided during the Expression of Interest webinars that will be held throughout April 2025.
International clinical trial
If you plan to run an international study, this may be considered for the Recruitment Service if there is a clear UK arm of the study, where the Data Controller is in the UK.
Information Governance
If you are selected for one of the pilot slots, all Data Controllers will be expected to complete a Data Sharing Framework Contract and submit a Data Sharing Agreement (DSA) application with NHS England. Applications must provide evidence that their data request complies with strict data governance standards, and the NHS DigiTrials team will help you through this process.
Once the DSA is in place NHS DigiTrials would use the trials inclusion and exclusion criteria to find potential participants to invite to take part. We would then create a cohort of people to send an invitation to and send these invitations on behalf of the trial.
Data sets available to the Recruitment Service
We cannot access primary care data, National Diabetes Audit or data collected under GP Data for Pandemic Planning and Research (GDPPR).
Last edited: 14 March 2025 2:53 pm