Pilot NHS DigiTrials Recruitment Support Services Directions 2021

To enable NHS Digital to enhance its support for health and life sciences research, by developing new elements of an NHS Data-Enabled Clinical Trials Service (NHS DigiTrials). This will help set the UK on a pathway to become a world-leader in clinical research - bringing health and economic benefits of research to UK citizens as well as to the NHS, including supporting recovery COVID-19. 

These Directions enable NHS Digital to provide the Pilot NHS DigiTrials Recruitment Support Service to a maximum of four clinical research trials to test the concept. This will use routinely collected NHS data to

• widen the diversity of those given the opportunity to participate in clinical trials
• enable faster, more efficient and effective trial set-up
• increase overall recruitment to clinical trials

Sections 254(1) and (6), section 260(2)(d), section 261(2)(e) and section 304(9), (10) and (12) of the Health and Social Care Act 2012 (the 2012 Act) and Regulation 32 of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 (the Regulations).

This Direction came into effect on 30 July 2021.