BMJ Open (Jun 2021)
Realising the full potential of data-enabled trials in the UK: a call for action
- Catherine Hewitt,
- Ian Roberts,
- Michael King,
- Irwin Nazareth,
- Alan Watkins,
- Frank Sullivan,
- Derek Stewart,
- Nick Freemantle,
- Jane Daniels,
- Tobias Dreischulte,
- Brooke Jackson,
- Michael Donnelly,
- Martin Landray,
- Martin Gulliford,
- David A Harrison,
- Adam Streeter,
- Jennifer Logue,
- Paula Williamson,
- Marion Campbell,
- Martin C Gulliford,
- Jamie Soames,
- Dheeraj Rai,
- Stephanie MacNeill,
- Marion Bennie,
- Jo Rycroft-Malone,
- Matthew R Sydes,
- Andrew Farmer,
- 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,
- 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,
- Hwyel Williams
Affiliations
- Catherine Hewitt
- York Trials Unit, Department of Health Sciences, University of York, York, UK
- Ian Roberts
- professor in epidemiology
- Michael King
- 1 Division of Psychiatry, University College London, London, London, UK
- Irwin Nazareth
- Research Department of Primary Care and Population Health, University College London, London, UK
- Alan Watkins
- 1 Medical School, Swansea University, Swansea, UK
- Frank Sullivan
- 8 Medical School, University of St Andrews, St Andrews, UK
- Derek Stewart
- 1 School of Pharmacy and Life Sciences, The Robert Gordon University, Aberdeen, UK
- Nick Freemantle
- University College London Institute of Clinical Trials and Methodology, London, UK
- Jane Daniels
- 7 Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK
- Tobias Dreischulte
- Scottish Improvement Science Collaborating Centre (SISCC), School of Nursing and Health Sciences, University of Dundee, Dundee, Angus, UK
- Brooke Jackson
- 3 Clinical Practice Research Datalink (CPRD), Medicines and Healthcare Products Regulatory Agency, London, UK
- Michael Donnelly
- Centre for Public Health, Queen's University Belfast, Belfast, UK
- Martin Landray
- Nuffield Department of Population Health, University of Oxford, Oxford, UK
- Martin Gulliford
- professor of public health
- David A Harrison
- 1 Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK
- Adam Streeter
- 4 Medical Statistics, Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, UK
- Jennifer Logue
- BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Science, University of Glasgow, Glasgow, UK
- Paula Williamson
- 2 Medical Research Council North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, UK
- Marion Campbell
- Martin C Gulliford
- School of Population Health and Environmental Sciences, King’s College London, Faculty of Life Sciences and Medicine, London, UK
- Jamie Soames
- 2Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory Agency, London, UK
- Dheeraj Rai
- 3 NIHR Biomedical Research Centre at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol, Bristol, UK
- Stephanie MacNeill
- Bristol Medical School, University of Bristol, Bristol, UK
- Marion Bennie
- 1 Health Data Research Scotland, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK
- Jo Rycroft-Malone
- School of Health Sciences, Bangor University, Bangor, UK
- Matthew R Sydes
- 1 MRC Clinical Trials Unit at UCL, UCL, London, UK
- Andrew Farmer
- Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- Martyn Lewis
- School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK
- Elizabeth Williamson
- professor of biostatistics and health data science
- Xavier Griffin
- 3 Nuffield Dept of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), Kadoorie Centre, John Radcliffe Hospital, Oxford, Oxfordshire, UK
- Colin McCowan
- 3 School of Medicine, University of St. Andrews, Saint Andrews, UK
- John Wilding
- Department of Cardiovascular and Metabolic Medicine, University of Liverpool Institute of Ageing and Chronic Disease, Liverpool, UK
- Jennifer Quint
- 2 National Heart and Lung Institute, Imperial College, London, United Kingdom
- Agnieszka Michael
- 5 Department of Oncology, University of Surrey, Guildford, United Kingdom
- Murali Shyamsundar
- Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, UK
- Tom Denwood
- 9 NHS Digital, Leeds, UK
- Deborah Ashby
- professor
- Jacqui Nuttall
- senior trial manager
- Kate Williams
- Department of Behavioural Science and Health, University College London, London, UK
- Doreen Tembo
- senior research manager patient and public involvement and external review
- David Harrison
- Research Department for Medical Education, University College London Medical School, London, UK
- Andrew Morris
- Loughborough University, Loughborough, UK
- Fiona Lobban
- Spectrum Centre for Mental Health Research, Lancaster University, Lancaster, UK
- Claire Snowdon
- research fellow
- Martin Gibson
- Endocrinology and Diabetes, Salford Royal Hospital, Salford, UK
- Rhoswyn Walker
- Medical School, University of Birmingham, Medical Research Council, London, UK
- Will Whiteley
- Specialist Registrar in Neurology, Department of Clinical Neurosciences, Western General Hospital, Crewe Road Edinburgh, EH4 2XU; E-mail: [email protected]
- Nick Mills
- 1University of Edinburgh
- Juliet Tizzard
- Director, Progress Educational Trust, London
- Emer Brady
- 1University of Leicester, Leicester, UK
- Guillermo Lopez Campos
- 1Queens University Belfast, Belfast, UK
- Catrin Tudur Smith
- University of Liverpool, UK
- Yolanda Barbachano
- Medicines and Healthcare products Regulatory Agency (MHRA), London, UK
- Steph Garfield-Birkbeck
- Trials and Studies Coordinating Centre, National Institute for Health Research Evaluation, Southampton, UK
- Will Navaie
- Health Research Authority, London, UK
- Martin O'Kane
- Medicines and Healthcare products Regulatory Agency (MHRA), London, UK
- Jonathan Sheffield
- NIHR Clinical Research Network, University of Leeds, Leeds, UK
- Paula Walker
- Medicines and Healthcare products Regulatory Agency (MHRA), London, UK
- Rhoswyn R Walker
- Health Data Research UK, London, UK
- Janet Valentine
- Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory Agency, London, UK
- 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
- research fellow
- Jo Rycroft‑Malone
- Matthew Sydes
- Hwyel Williams
- DOI
- https://doi.org/10.1136/bmjopen-2020-043906
- Journal volume & issue
-
Vol. 11,
no. 6
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.
