ISCF HDRUK DIH Sprint Exemplar: Using Routine NHS Data to Accelerate Clinical Trial Recruitment

Lead Research Organisation: University of Oxford

Abstract

Every NHS hospital keeps a detailed record of activities both for the purposes of individual patient care and to ensure that the hospital is properly paid for the work that it does. A monthly report of activity, described in terms of ‘hospital episodes’ is sent to NHS Digital, who host the data in trust for the nation. Large-scale, randomised clinical trials allow us to establish whether or not a particular treatment works and whether it is safe. This knowledge is invaluable: without it, hospitals might be reluctant to adopt some new, life-saving innovation, or a new, more effective medicine might remain unproven and unused. However, clinical trials can be very expensive to conduct and many fail to recruit sufficient numbers of patients to allow them to provide a conclusive answer in a timely fashion.
This project will develop a system that uses the ‘hospital episodes’ information to identify potentially suitable patients from across the country so that they could be asked if they wished to take part in clinical trials. Previous studies have demonstrated that such an approach can be very successful in recruiting large numbers of patient volunteers to join major clinical research studies.

Technical Summary

This project will deliver a secure, web-based service that uses data assets managed by NHS Digital to facilitate recruitment into large clinical trials and other research projects. There will be two components:
a) A metadata catalogue to facilitate use of HES data adapted from the NIHR Oxford Biomedical Research Centre catalogue toolkit. This will support annotation and
computable representation of source data, trial eligibility criteria, and data extraction requests.
b) A web-enabled system to facilitate clinical trial recruitment based on the NWEH FARSITE system originally designed for primary care. This will allow authorised
users to configure eligibility selection criteria (e.g. age-range, diagnosis), filter search results (e.g. by hospital), and generate lists of eligible individuals.
The work will be co-designed by experts in clinical trial design, data engineering, information governance, and NHS Digital systems and data assets. The work will be
evaluated using contemporary and hypothetical trial protocols, and demonstrated to potential users, including industry representatives. The project is time-limited but will inform the design and implementation of future systems to facilitate data-enabled clinical trials, prospective cohorts, and precision medicine studies. It will also provide an important component for an upgraded NIHR Health Data Finder.

Publications

10 25 50
 
Description Chair, NHS DigiTrials Board 
Organisation NHS Digital
Country United Kingdom 
Sector Public 
PI Contribution Technical co-development of conformed data layer and services layer. Coordination of Patient & Public Involvement and Engagement, including PPI members on the Board, Co-development Panel, public engagement meetings (Sophia has details), Use cases for ascertainment of clinical outcomes and for mailing 13,000 participants with information about trial results applied to RECOVERY trial.
Collaborator Contribution Invitation services piloted for UK vaccine trials and the PRINCIPLE trial Microsoft and IBM partners contributed technical and service design expertise.
Impact Feasibility service (beta release); support for the RECOVERY trial including information on study outcomes to support 6 key findings that have impacted NHS and global treatment policies for COVID-19 (dexamethasone & tocilizumab save lives; hydroxychloroquine, lopinavir, azithromycin, convalescent plasma, colchicine are ineffective).
Start Year 2019
 
Description Global Hearts Initiative: Expanding the Evidence Base for Cardiovascular Disease Risk Factors 
Organisation Centers for Disease Control and Prevention (CDC)
Country United States 
Sector Public 
PI Contribution Collaboration with Global Non-Communicable Disease Branch of the US Center of Disease Control. Funding from CDC-Foundation. Title 'Global Hearts Initiative: Expanding the Evidence Base for Cardiovascular Disease Risk Factors'. There is a formal agreement in place.
Collaborator Contribution academic partnership
Impact n/a
Start Year 2019
 
Description Good Clinical Trials Initiative 
Organisation African Academy of Sciences
Country Kenya 
Sector Charity/Non Profit 
PI Contribution Development of new guidelines for randomised controlled trials (ongoing)
Collaborator Contribution Widespread, cross-sector, national and international engagement (including pharma, academia, WHO, FDA, EMA, MHRA, ICH, AMS, NIHR, UKRI, G7, and patient advocacy organisations)
Impact consultation meetings held; draft guidelines under development
Start Year 2019
 
Description Good Clinical Trials Initiative 
Organisation Bill and Melinda Gates Foundation
Country United States 
Sector Charity/Non Profit 
PI Contribution Development of new guidelines for randomised controlled trials (ongoing)
Collaborator Contribution Widespread, cross-sector, national and international engagement (including pharma, academia, WHO, FDA, EMA, MHRA, ICH, AMS, NIHR, UKRI, G7, and patient advocacy organisations)
Impact consultation meetings held; draft guidelines under development
Start Year 2019
 
Description Good Clinical Trials Initiative 
Organisation Wellcome Trust
Country United Kingdom 
Sector Charity/Non Profit 
PI Contribution Development of new guidelines for randomised controlled trials (ongoing)
Collaborator Contribution Widespread, cross-sector, national and international engagement (including pharma, academia, WHO, FDA, EMA, MHRA, ICH, AMS, NIHR, UKRI, G7, and patient advocacy organisations)
Impact consultation meetings held; draft guidelines under development
Start Year 2019
 
Description RECOVERY Trial 
Organisation Medical Research Council (MRC)
Country United Kingdom 
Sector Public 
PI Contribution Co-chief investigator Trial design, coordination, and delivery, including patient & public engagement, extensive media activities, use of routine data (from NHS DigiTrials and other NHS organisations), policy implications (with Rapid C19 group, DHSC, NHS, and internationally with FDA, EMA, WHO, NIH), and education 177 NHS hospitals + NHS DigiTrials + NHS Blood Transfusion
Collaborator Contribution MRC - financial. NHS Trusts - Incorporated the trial daily working practices for COVID-19 care; administered treatments as part of the trial
Impact 10 key findings (4 since last year) that have impacted NHS and global treatment policies for COVID-19 (dexamethasone, tocilizumab, casirivimab+imdevimab, baricitinib save lives; hydroxychloroquine, lopinavir, azithromycin, convalescent plasma, colchicine and aspirin do not). Use of dexamethasone, tocilizumab, casirivimab+imdevimab were adopted into NHS, NIH and WHO treatment guidelines.
Start Year 2020
 
Description Activity for the RECOVERY Trial 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact During the RECOVERY Trial, which investigates the efficacy of COVID treatments for hospitalized patients, trial investigators took part in media interviews on multiple occasions with media organisations across the world. This resulted in televised interviews, thousands of printed and digital media articles that have showcased this importance of this trial worldwide.
Year(s) Of Engagement Activity 2020,2021,2022
 
Description Inside Health 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact RECOVERY Trial featured on BBC R4's Inside Health in April 2021
Year(s) Of Engagement Activity 2021
 
Description Making Clinical Trials easier 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact Type of event - Magazine-style - an online mix of discussion, film and quiz X3
Number of attendees - 35 per event
Primary audience - members of the public: adults in England
Title - Making Clinical Trials Easier
Year(s) Of Engagement Activity 2020
 
Description NHS Digitrials public panel 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact 'What are clinical trials? presented as part of the NHS Digitrials public panel
Year(s) Of Engagement Activity 2020