1. Realising the full potential of data-enabled trials in the UK: a call for action
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Andrea Cipriani, Steve Goodacre, Jennifer K Quint, Catherine Hewitt, Ian Roberts, John Norrie, Aziz Sheikh, Michael King, Irwin Nazareth, Alan Watkins, Frank Sullivan, Derek Stewart, Nick Freemantle, Liam Smeeth, Jane Daniels, Tobias Dreischulte, Brooke Jackson, Michael Donnelly, Martin Landray, Martin Gulliford, Mark Edwards, Paula R Williamson, David A Harrison, Adam Streeter, Jennifer Logue, Paula Williamson, Louise Bowman, Marion Campbell, Martin C Gulliford, Jamie Soames, Dheeraj Rai, Stephanie MacNeill, Marion Bennie, Jo Rycroft-Malone, Matthew R Sydes, Andrew Farmer, Hywel C Williams, Martyn Lewis, Elizabeth Williamson, Xavier Griffin, Colin McCowan, John Wilding, Jennifer Quint, Agnieszka Michael, Murali Shyamsundar, Tom Denwood, Deborah Ashby, Jacqui Nuttall, Kate Williams, Doreen Tembo, David Harrison, Andrew Morris, Laura Gray, Fiona Lobban, Claire Snowdon, Martin Gibson, Rhoswyn Walker, Will Whiteley, Nick Mills, Juliet Tizzard, Emer Brady, Guillermo Lopez Campos, Catrin Tudur Smith, Yolanda Barbachano, Steph Garfield-Birkbeck, Will Navaie, Martin O'Kane, Jonathan Sheffield, Paula Walker, Rhoswyn R Walker, Janet Valentine, Susan Beatty, Helen Bodmer, Paul Brocklehurst, Steph Garfield‑Birkbeck, Doug Gould, Thomas Hiemstra, Anna Higgins, Julia Hippisley‑Cox, Sasha Korniak, Marion Mafham, Kathleen Meeley, Chris Newby, Martin O’Kane, Mike Robling, Jo Rycroft‑Malone, Matthew Sydes, and Hwyel Williams
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Medicine - 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.
- Published
- 2021
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