BMJ Open (Jun 2021)
Realising the full potential of data-enabled trials in the UK: a call for action
- 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,
- Hwyel Williams
Affiliations
- Andrea Cipriani
- 6 Department of Psychiatry, University of Oxford, Oxford, UK
- Steve Goodacre
- professor of emergency medicine
- Jennifer K Quint
- School of Public Health, Imperial College London, London, UK
- Catherine Hewitt
- 4 Health Sciences, University of York, York, UK
- Ian Roberts
- professor
- John Norrie
- Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK
- Aziz Sheikh
- Usher Institute, University of Edinburgh College of Medicine and Veterinary Medicine, Edinburgh, UK
- Michael King
- Division of Psychiatry, Faculty of Brain Sciences, London, UK
- Irwin Nazareth
- 36 Primary Care & Population Science, University College London, London, UK
- Alan Watkins
- Swansea University Medical School, Swansea University, Swansea, UK
- Frank Sullivan
- director of University of Toronto Practice-Based Research Network (UTOPIAN), Gordon F Cheesbrough chair in family and community medicine
- Derek Stewart
- patient and public involvement partner
- Nick Freemantle
- Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK
- Liam Smeeth
- professor
- Jane Daniels
- Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham Faculty of Medicine and Health Sciences, Nottingham, Nottingham, UK
- Tobias Dreischulte
- Department of General Practice and Family Medicine, LMU Hospital, Munich, Germany
- Brooke Jackson
- Michael Donnelly
- Centre for Public Health and UKCRC Centre of Excellence for Public Health, Queen`s University Belfast, Belfast, UK
- Martin Landray
- professor of medicine and epidemiology
- Martin Gulliford
- professor
- Mark Edwards
- Neuropsychiatry Research and Education Group, Institute of Psychiatry Psychology & Neuroscience, King`s College London, London, UK
- Paula R Williamson
- 18 University of Liverpool, Liverpool, UK
- David A Harrison
- Intensive Care National Audit and Research Centre, London, UK
- Adam Streeter
- Jennifer Logue
- Lancaster Medical School, Lancaster University, Lancaster, UK
- Paula Williamson
- MRC-NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool, Liverpool, Merseyside, UK
- Louise Bowman
- 2Royal Bournemouth Hospital
- Marion Campbell
- Health Services Research Unit, University of Aberdeen, Aberdeen, UK
- Martin C Gulliford
- King`s College London, UK, London, UK
- Jamie Soames
- Department of Health Services Research and Policy, Faculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, London, UK
- Dheeraj Rai
- Centre for Academic Mental Health, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK
- Stephanie MacNeill
- Population Health Sciences, University of Bristol, Bristol, UK
- Marion Bennie
- 5 Pharmaceutical Sciences, University of Strathclyde, Glasgow, UK
- Jo Rycroft-Malone
- Faculty of Health and Medicine, Lancaster University, Lancaster, UK
- Matthew R Sydes
- MRC Clinical Trials Unit at UCL, London, UK
- Andrew Farmer
- 3 Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- Hywel C Williams
- Lifespan and Population Health, University of Nottingham, Nottingham, UK
- Martyn Lewis
- School of Medicine, Keele University, Staffordshire, UK
- Elizabeth Williamson
- Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK
- Xavier Griffin
- Colin McCowan
- School of Medicine, University of St Andrews, St Andrews, Fife, UK
- John Wilding
- professor of medicine
- Jennifer Quint
- 2 National Heart and Lung Institute, Imperial College, London, United Kingdom
- Agnieszka Michael
- Department of Clinical and Experimental Medicine, University of Surrey, Guildford, UK
- Murali Shyamsundar
- Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Sciences, Queen’s University Belfast, Belfast, UK
- Tom Denwood
- 9 NHS Digital, Leeds, UK
- Deborah Ashby
- codirector
- Jacqui Nuttall
- 11 Southampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK
- Kate Williams
- Australian Government Aged Care Quality and Safety Commission, Canberra, Australian Capital Territory, Australia
- Doreen Tembo
- Wessex Institute, Faculty of Medicine, University of Southampton, Southampton, UK
- David Harrison
- 1 Research Department for Medical Education, University College London, London, UK
- Andrew Morris
- Health Data Research UK, London, UK
- Laura Gray
- Department of Health Sciences, University of Leicester, Leicester, UK
- Fiona Lobban
- Spectrum Centre for Mental Health Research, Division of Health Research, Lancaster University, Lancaster, UK
- Claire Snowdon
- Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK
- Martin Gibson
- North West E‑Health (NWEH) Ltd, Manchester, UK
- Rhoswyn Walker
- Will Whiteley
- Nick Mills
- Juliet Tizzard
- Health Research Authority, London, UK
- Emer Brady
- 1University of Leicester, Glenfield Hospital, Groby Road, Leicester, LEC LE39QP, UK
- Guillermo Lopez Campos
- Catrin Tudur Smith
- 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
- School of Medical and Health Sciences, Bangor University, Bangor, UK
- Steph Garfield‑Birkbeck
- Doug Gould
- Thomas Hiemstra
- Anna Higgins
- Julia Hippisley‑Cox
- Sasha Korniak
- Marion Mafham
- Nuffield Department of Population Health, University of Oxford, Oxford, UK
- Kathleen Meeley
- Chris Newby
- Martin O’Kane
- Mike Robling
- Jo Rycroft‑Malone
- Matthew Sydes
- MRC Clinical Trials Unit, University College London, London, UK
- 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.
