Abstract
BackgroundThe COVID-19 pandemic has presented unique challenges for rapidly designing, initiating, and delivering therapeutic clinical trials. PRINCIPLE (Platform Randomised Trial of Treatments in the Community for Epidemic and Pandemic Illnesses) is the UK national platform investigating repurposed therapies for COVID-19 treatment of older people in the community at high risk of complications. Standard methods of patient recruitment were failing to meet the required pace and scale of enrolment.This paper describes the development and appraisal of a near real-time, data-driven, ethical approach for enhancing recruitment in community care by contacting people with a recent COVID-19 positive test result from the central NHS Test and Trace service within approximately 24–48 h of their test result.MethodsA multi-disciplinary team was formed to solve the technical, ethical, public perception, logistical and information governance issues required to provide a near-real time (approximately within 24–48 h of receiving a positive test) feed of potential trial participants from test result data to the research team. PRINCIPLE was also given unique access to the Summary Care Record (SCR) to ensure safe prescribing, and to enable the trial team to quickly and safely bring consented patients into the trial. A survey of the public was used to understand public perceptions of the use of test data for this proposed methodology.ResultsPrior to establishing the data service, PRINCIPLE registered on average 87 participants per week. This increased by up to 87 additional people registered per week from the test data, contributing to an increase from 1013 recruits to PRINCIPLE at the start of October 2020 to 2802 recruits by 20 December 2020.Whilst procedural caveats were identified by the public consultation, out of 2639 people contacted by PRINCIPLE following a positive test result, no one raised a concern about being approached.ConclusionsThis paper describes a novel approach to using near-real time NHS operational data to recruit community-based patients within a few days of presentation with acute illness.This approach increased recruitment and reduced time between positive test and randomisation, allowing more rapid evaluation of treatments and increased safety for participants. End-to-end public and patient involvement in the design of the approach provided evidence to inform information governance decisions.Trial registrationPRINCIPLE is funded by UK Research and Innovation and the Department of Health and Social Care through the National Institute for Health Research.EudraCT number: 2020-001209-22. 26/03/2020ISRCTN registry: ISRCTN86534580. 20/03/2020REC number: 20/SC/058IRAS number: 281958
Highlights
The COVID-19 pandemic has presented unique challenges for rapidly designing, initiating, and delivering therapeutic clinical trials
This paper describes a novel approach to using near-real time National Health Service (NHS) operational data to recruit community-based patients within a few days of presentation with acute illness
The initiative was a partnership between the PRINCIPLE investigators and coordinating centre at the University of Oxford, the UK National Core Studies Programmes (Therapeutics; Data and Connectivity), the NHS Digital Information Governance Team, the Information Commissioner’s Office, NHS Test and Trace, the NHS DigiTrials Health Data Research Hub, the Department of Health and Social Care (DHSC) and the Health Data Research UK (HDR UK) Public & Patient Involvement and Engagement Team
Summary
The COVID-19 pandemic has presented unique challenges for rapidly designing, initiating, and delivering therapeutic clinical trials. PRINCIPLE (Platform Randomised Trial of Treatments in the Community for Epidemic and Pandemic Illnesses) is the UK national platform investigating repurposed therapies for COVID-19 treatment of older people in the community at high risk of complications. There were no specific treatments for people with COVID-19 with proven effectiveness suitable for use in the community. The Platform Randomised trial of INterventions against COVID-19 In older people (PRINCIPLE) [3] was established in March 2020 as an Urgent Public Health, UK-wide National Priority Platform to evaluate the effects of repurposed drugs for people in the community with SARS-CoV2 infection who are at high risk of complications. The study aims to evaluate whether repurposed medicines speed recovery and reduce the need for hospitalisation and reduce deaths in people with suspected or proven COVID-19. PRINCIPLE used traditional methods of primary care recruitment through general practices that were opened as study sites, with primary care clinicians checking eligibility and dispensing or prescribing study medications themselves
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