Realising the full potential of data-enabled trials in the UK: a call for action

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

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 (EHR). Opportunities exist to utilise 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 (HDR UK) and Clinical Practice Research Datalink (CPRD) 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 post-marketing authorisation trials where research-relevant outcome measures are readily collectable. Sharing of case studies is encouraged. The workshop directly informed NIHR’s funding call. ambitious data-enabled trials at scale. There is the opportunity for the United Kingdom to build upon existing data science capabilities to identify, recruit and monitor patients in trials at scale.

Citation

Sydes, M. R., Barbachano, Y., Bowman, L., Denwood, T., Farmer, A., Garfield-Birkbeck, S., Gibson, M., Gulliford, M. C., Harrison, D. A., Hewitt, C., Logue, J., Navaie, W., Norrie, J., O’Kane, M., Quint, J. K., Rycroft-Malone, J., Sheffield, J., Smeeth, L., Sullivan, F., Tizzard, J., …Valentine, J. (2021). Realising the full potential of data-enabled trials in the UK: a call for action. BMJ Open, 11(6), 1-15. https://doi.org/10.1136/bmjopen-2020-043906

• Journal Article Type: Article
• Acceptance Date: May 4, 2021
• Online Publication Date: Jun 16, 2021
• Publication Date: 2021-06
• Deposit Date: May 14, 2021
• Publicly Available Date: Jun 16, 2021
• Journal: BMJ Open
• Electronic ISSN: 2044-6055
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 11
• Issue: 6
• Article Number: e043906
• Pages: 1-15
• DOI: https://doi.org/10.1136/bmjopen-2020-043906
• Keywords: General Medicine
• Public URL: https://nottingham-repository.worktribe.com/output/5529530
• Publisher URL: https://bmjopen.bmj.com/content/11/6/e043906