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Requirements specification for Pilot NHS DigiTrials Recruitment Support Services Directions 2021

This specification sets out the requirements for the pilot NHS DigiTrials Recruitment Support Services and should be read alongside the Pilot NHS DigiTrials Recruitment Support Services Directions 2021 issued by The Department of Health and Social Care (Secretary of State) on 30 July 2021. 

NHS DigiTrials is developing a range of data services to support clinical trials and other health research that creates public value. These will use routinely collected NHS health related data to reduce the time, effort and expense of developing diagnostics, vaccines, medicines and health technologies to improve health and care.  The new pilot services will be developed in collaboration with potential users (researchers conducting approved clinical trials) and underpinned by strong public and patient engagement and co-development.  

NHS Digital is able to provide many of these services under its existing legal vires as set out in the Health and Social Care Act 2012 – this includes the ability to provide functions connected with the delivery of additional services, analysis, publication or other dissemination of information.  However, NHS Digital does need additional legal vires - through Directions - to deliver the Pilot Recruitment Support Service.  Hence the limited and specific scope of this - the Pilot NHS DigiTrials Recruitment Support Services Directions 2021.

Although the NHS DigiTrials Services are primarily aimed at clinical trials it is recognised that the services may also benefit wider healthcare research.  Throughout this document the term ‘clinical trial’, ‘trial’ and ‘trialist’ are used for simplicity, but it should be noted that the NHS DigiTrials services may be used to support any clinical research that meets the definition as set out in the UK Policy Framework for Health and Social Care Research and as overseen by the Health Research Authority


Service development and funding

During the Covid pandemic NHS DigiTrials delivered services on an ad hoc basis in response to urgent needs to support public health research including life-saving vaccine and therapeutics clinical trials. This was supported by the COVID Directions.

Building on this work and in advance of the 2020 spending review, Office for Life Sciences (OLS), Department Health and Social Care Science, Research and Evidence Directorate (DHSC SRE), and NHSx Centre for Improving Data Collaboration undertook detailed stakeholder engagement and programme planning to secure the initial funding needed for a holistic data-enabled find, recruit, and follow-up (FRF) service.

NHS Digital has been funded as a data services delivery partner for the FRF programme and has been commissioned to deliver a range of data services to support clinical trials and wider healthcare research – NHS DigiTrials Services. Other FRF partners include the Health Research Authority (HRA) and National Institute for Health Research (NIHR). 

NHS Digital has robust governance around the processing of the data it holds, and a legal basis will be required for all data processing conducted by NHS DigiTrials.


Pilot NHS DigiTrials Recruitment Support Service

NHS Digital is engaging in proof-of-concept activity until 31 December 2022 to support wider and more diverse recruitment to clinical trials. The activity will be limited to no more than four large scale trials which each offer significant potential to improve health outcomes.  These four pilot studies will focus on research into the early diagnosis and treatment of conditions with a significant health burden including cancer, cardiovascular disease and diabetes.

The proof-of-concept work will enable further consultation and evaluation, which will involve user research and patient feedback.  The Directions will be reviewed and may be updated as a result of the outcomes of the proof-of-concept work.

The Pilot NHS Digitals Recruitment Services Directions 2021 are limited to analysis and linkage of data and only the NHS DigiTrials services aimed at supporting recruitment to trials fall within the remit of these Directions. Specifically:

  • NHS Digital is Directed to analyse and link the data it holds as Controller to find the widest pool of suitable participants for health improving clinical research, for the purposes of inviting, on behalf of the trial, these individuals to express an interest in participating. 
  • This includes the development of linked data assets as required to deliver the NHS DigiTrials services that brings together a patient centric view of data already held in NHS Digital.
 

Please see purpose of DigiTrials recruitment support services. 

This service will build on initial discovery work but will be scoped and designed with all FRF partners and in collaboration with potential users of the services (researchers conducting approved clinical trials) as well as public and patient representatives. This capability aims to increase participation in research in line with ambitions within the NHS Long Term Plan.

Information about the other NHS DigiTrials services that are being developed is available online. 

These pilot Directions are limited to supporting recruitment to no more than four proof of concept studies and will end in December 2022 unless extended, replaced or revoked.


Benefits to health and social care

The delivery of the NHS DigiTrials Recruitment Support Service is anticipated to yield a range of benefits to the healthcare research community by providing controlled access to high quality data for the purpose of healthcare research, including clinical trials.  Most notably use of the Recruitment Support Services will:

  • Enhance opportunities for the widest possible group of individuals to participate in vital clinical research to address large scale public health risks
  • Improve the diversity of research cohorts such that those who are offered the opportunity take part in research, become more representative of the population 
  • Support faster participant recruitment to more quickly find answers to important clinical questions
  • Reduce the cost of running clinical trials and other important research. This will provide particular benefit for publicly funded studies such as those which ran during the COVID-19 global pandemic
  • Reduce the burden of trial administration and data collection from front line clinicians and healthcare settings
  • Support a thriving UK life sciences research sector by reducing the costs of running trials and attracting more research to the UK
  • Ultimately improve NHS services and access to evidence-based diagnostics, vaccines and treatments for the wider population

Purpose of the DigiTrials Recruitment Support Services

NHS Digital has been Directed, via the Pilot NHS DigiTrials Recruitment Support Services Directions 2021, to undertake activity to enable NHS DigiTrials to find potential research participants.

This a pilot programme which will be limited to four large scale trials.

Scope

There are a number of health conditions that pose significant public health risks including cancer, cardiovascular disease and diabetes.  Early detection and diagnosis of conditions with significant health burdens relies on recruitment to large scale research trials and widening participation such that those participating in research are a more diverse representation of the population.

The elements of the NHS DigiTrials Recruitment Services relevant to the Pilot NHS DigiTrials Recruitment Support Services Directions 2021 (the Services) are:

A service to identify individuals who are suitable for invitation to participate in  clinical research projects that aim to improve health outcomes, once approved by the Health Research Authority. NHS Digital will be responsible for developing capability to find potential participants by analysing and linking data it holds as Controller and procuring or developing appropriate approaches for finding potential participants.

These Directions do not provide a legal basis to process data on behalf of, or to disseminate data to, NHS DigiTrials customers.  All data processing to provide the NHS DigiTrials services must be supported by a clear legal basis e.g. the trial may be supported by an approval under s251 of the NHS Act 2006, patient consent or any other relevant legislation, as well as an appropriate legal basis under the UK General Data Protection Regulations  and Data Protection Act 2018.      

NHS Digital will be responsible for onboarding, processing, linking and making data available for use in the Services, including meeting bespoke needs for specific trials as far as possible and appropriate.  This includes the development of linked data sets as required to deliver the NHS DigiTrials services that brings together a more holistic, patient centric view of data already held in NHS Digital.

Data collection

No additional data collection is required as part of this specification. NHS Digital is the national information and technology partner for the health and care system, data which NHS Digital holds as Controller will be used to provide the services.

Analysis and linkage

NHS Digital is directed to use data it holds as Controller to find suitable participants for vital clinical research, for the purposes of inviting these individuals to express an interest in participating. 

The directed activity is limited to finding suitable participants only.

The directed activity for the pilot recruitment services involves:

  • applying the cohort criteria, to the datasets NHS Digital holds as Controller (subject to any restrictions in the directions or statutory requests relating to that data), specified by the Trial; and
  • analysing and linking that data as necessary to create a suitable participant list for the purposes of inviting individuals to participate; and
  • the analysis and linkage shall be undertaken on identifiable data, which may include special category data, given that health conditions may be used in cohorting.

The directed activity is limited to finding of suitable research participants only. 

Any further processing by NHS Digital on behalf of a Trial, including inviting potential participants, must be separately supported by a clear legal basis e.g. the trial may be supported by an approval under s251 of the NHS Act 2006, patient consent or any other relevant legislation, as well as an appropriate legal basis under the UK General Data Protection Regulations and Data Protection Act 2018. All approved healthcare research that meets the definition as set out in the UK Policy Framework for Health and Social Care Research must be overseen by the Health Research Authority including review by a Research Ethics Committee and where appropriate, reviewed by the Confidentiality Advisory Group (CAG).


Consultation

There have been a number of User Research and Discovery pieces of work undertaken for the DigiTrials Recruitment Support Service:

Recruitment Support Services/ Participant Search & Find (January 2021 – May 2021)

This involved consultation with various stakeholders including PPIE stakeholders:

  • NHS DigiTrials Board which includes individuals from University of Oxford, IBM, Microsoft, Health Research Authority (HRA), NIHR CRN, Health Data Research UK (HDR UK), Department of Health and Social Care (DHSC), NHS X and Patient/Public representatives from the NHS DigiTrials Co-Development Panel.
  • NHS DigiTrials Co-development Panel (comprised of patients and the public)
  • NHS DigiTrials Customer User Group – this includes individuals from ABPI, HDR UK, University of Oxford, Cancer Research UK, MRC, NIHR, BHF, UKRD, University Leeds CTU, MRC CTU, Patient/Public representatives,
  • Four PPIE events with under-represented groups into their views on receiving invitations to Clinical Trials without consent
    • LGBTQ+
    • Individuals with learning disabilities
    • Young people with cancer
    • Individuals with muscular skeletal disorders
  • 20 user research interviews

In order to secure funding for Find, Recruit, Follow-up (FRF), DHSC have separately undertaken extensive consultation.

Finally, the benefit of the NHS DigiTrials services have been clearly demonstrated during the Covid-19 pandemic with a series of high-profile clinical trials where data provided by NHS Digital has delivered the following benefits:

PRINCIPLE trial: NHS DigiTrials provided daily flow of contact details for eligible patients and facilitated access to Summary Care Record to support safe prescribing. This at least doubled recruitment rates

  • RECOVERY trial: Fast access to outcomes data has identified two effective treatments for those hospitalised with COVID-19. These treatments are saving lives around the world.
  • NOVAVAX vaccine trial: 55% of volunteers were recruited via NHS Vaccine Registry (joint NHS DigiTrials/NIHR), completed recruitment in 2 months (Oct-Nov) and provided covid test data for participants enabling results announced in January.
  • HOSTED: Bespoke data pipeline developed to enable analysis of role of household transmission in overall infection rates.  Novel data linkage approach and first project to receive vaccination data. Recent results show one dose of the COVID-19 vaccine reduces household transmission by up to half.
  • HEAL-COVID: Providing health data to support trials into what treatments work for those left with long term after-effects from Covid (or “Long Covid”).

Dissemination/Sharing

Dissemination of personal data by NHS Digital is not a directed activity under the Pilot NHS DigiTrials Recruitment Support Services Directions 2021.

Therefore, any data access requests must be via the established end to end DARS process or in line with NHS Digital processes for release of aggregate or anonymised data

 

Data Access Request Service (DARS)

All trials requesting access to identifiable or pseudonymised data will be required to go through the end-to-end DARS process, including independent review and advice from IGARD. Dissemination must be supported by a clear legal basis e.g. the trial may be supported by an approval under s251 of the NHS Act 2006, patient consent or any other relevant legislation, as well as appropriate legal basis under the UK GDPR and the Data Protection Act 2018. All approved healthcare research that meets the definition as set out in the UK Policy Framework for Health and Social Care Research must be overseen by the Health Research Authority including review by a Research Ethics Committee and where appropriate, reviewed by the Confidentiality Advisory Group (CAG).


Publication

NHS Digital will not publish any information it obtains by complying with the Pilot NHS DigiTrials Recruitment Support Services Directions, except for the publication of anonymous statistical data (with small numbers suppressed).


Change control process

NHS Digital will manage any changes to this Specification in conjunction with, and by written agreement of an authorised officer of the Secretary of State.  Where necessary, Public Health England and the NHS England will be consulted on the changes.


Download a copy of this requirements specification as a pdf

Last edited: 18 January 2022 5:09 pm