Realising the full potential of data-enabled trials in the UK: a call for action. Issue 6 (16th June 2021)

• Record Type: Journal Article
• Authors: Sydes, Matthew R; Barbachano, Yolanda; Bowman, Louise; Denwood, Tom; Farmer, Andrew; Garfield-Birkbeck, Steph; Gibson, Martin; Gulliford, Martin C; Harrison, David A; Hewitt, Catherine; Logue, Jennifer; Navaie, Will; Norrie, John; O'Kane, Martin; Quint, Jennifer K; Rycroft-Malone, Jo; Sheffield, Jonathan; Smeeth, Liam; Sullivan, Frank; Tizzard, Juliet; Walker, Paula; Wilding, John; Williamson, Paula R; Landray, Martin; Morris, Andrew; Walker, Rhoswyn R; Williams, Hywel C; Valentine, Janet
• Other Names: author non-byline.; Ashby Deborah author non-byline.; Barbachano Yolanda author non-byline.; Beatty Susan author non-byline.; Bennie Marion author non-byline.; Bodmer Helen author non-byline.; Bowman Louise author non-byline.; Brady Emer author non-byline.; Brocklehurst Paul author non-byline.; Jackson Brooke author non-byline.; Campbell Marion author non-byline.; Cipriani Andrea author non-byline.; Daniels Jane author non-byline.; Denwood Tom author non-byline.; Donnelly Michael author non-byline.; Dreischulte Tobias author non-byline.; Edwards Mark author non-byline.; Farmer Andrew author non-byline.; Freemantle Nick author non-byline.; Garfield‑Birkbeck Steph author non-byline.; Gibson Martin author non-byline.; Goodacre Steve author non-byline.; Gould Doug author non-byline.; Gray Laura author non-byline.; Griffin Xavier author non-byline.; Gulliford Martin author non-byline.; Harrison David author non-byline.; Hewitt Catherine author non-byline.; Hiemstra Thomas author non-byline.; Higgins Anna author non-byline.; Hippisley‑Cox Julia author non-byline.; King Michael author non-byline.; Korniak Sasha author non-byline.; Landray Martin author non-byline.; Lewis Martyn author non-byline.; Lobban Fiona author non-byline.; Logue Jennifer author non-byline.; Campos Guillermo Lopez author non-byline.; MacNeill Stephanie author non-byline.; Mafham Marion author non-byline.; McCowan Colin author non-byline.; Meeley Kathleen author non-byline.; Michael Agnieszka author non-byline.; Mills Nick author non-byline.; Morris Andrew author non-byline.; Navaie Will author non-byline.; Nazareth Irwin author non-byline.; Newby Chris author non-byline.; Norrie John author non-byline.; Nuttall Jacqui author non-byline.; O'Kane Martin author non-byline.; Quint Jennifer author non-byline.; Rai Dheeraj author non-byline.; Roberts Ian author non-byline.; Robling Mike author non-byline.; Rycroft‑Malone Jo author non-byline.; Sheffield Jonathan author non-byline.; Sheikh Aziz author non-byline.; Shyamsundar Murali author non-byline.; Smeeth Liam author non-byline.; Snowdon Claire author non-byline.; Soames Jamie author non-byline.; Stewart Derek author non-byline.; Streeter Adam author non-byline.; Sullivan Frank author non-byline.; Sydes Matthew author non-byline.; Tembo Doreen author non-byline.; Tizzard Juliet author non-byline.; Smith Catrin Tudur author non-byline.; Valentine Janet author non-byline.; Walker Paula author non-byline.; Walker Rhoswyn author non-byline.; Watkins Alan author non-byline.; Whiteley Will author non-byline.; Wilding John author non-byline.; Williams Hwyel author non-byline.; Williams Kate author non-byline.; Williamson Elizabeth author non-byline.; Williamson Paula author non-byline.;
• Is Part Of: BMJ open. Volume 11:Issue 6(2021)
• Publication Date: 2021-06-16
• Subjects: health informatics -- statistics & research methods -- clinical trials; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-043906
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Rationale: Clinical trials are the gold standard for testing interventions. COVID-19 has further raised their public profile and emphasised the need to deliver better, faster, more efficient trials for patient benefit. Considerable overlap exists between data required for trials and data already collected routinely in electronic healthcare records (EHRs). Opportunities exist to use these in innovative ways to decrease duplication of effort and speed trial recruitment, conduct and follow-up. Approach: The National Institute of Health Research (NIHR), Health Data Research UK and Clinical Practice Research Datalink co-organised a national workshop to accelerate the agenda for 'data-enabled clinical trials'. Showcasing successful examples and imagining future possibilities, the plenary talks, panel discussions, group discussions and case studies covered: design/feasibility; recruitment; conduct/follow-up; collecting benefits/harms; and analysis/interpretation. Reflection: Some notable studies have successfully accessed and used EHR to identify potential recruits, support randomised trials, deliver interventions and supplement/replace trial-specific follow-up. Some outcome measures are already reliably collected; others, like safety, need detailed work to meet regulatory reporting requirements. There is a clear need for system interoperability and a 'route map' to identify and access the necessary datasets. Researchers running regulatory-facing trials must carefully consider how data quality and integrity would be assessed. An experience-sharing forum could stimulate wider adoption of EHR-based methods in trial design and execution. Discussion: EHR offer opportunities to better plan clinical trials, assess patients and capture data more efficiently, reducing research waste and increasing focus on each trial's specific challenges. The short-term emphasis should be on facilitating patient recruitment and for postmarketing authorisation trials where research-relevant outcome measures are readily collectable. Sharing of case studies is encouraged. The workshop directly informed NIHR's funding call for ambitious data-enabled trials at scale. There is the opportunity for the UK to build upon existing data science capabilities to identify, recruit and monitor patients in trials at scale.