| アブストラクト | 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. |
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| 投稿者 | 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 |
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| 組織名 | MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology,;University College London, London, UK m.sydes@ucl.ac.uk.;Medicines and Healthcare products Regulatory Agency (MHRA), London, UK.;MRC Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield;Department of Population Health, University of Oxford, Oxford, UK.;NHS Digital, Leeds, UK.;Nuffield Department of Primary Care Health Sciences, University of Oxford,;Oxford, UK.;Trials and Studies Coordinating Centre, National Institute for Health Research;Evaluation, Southampton, UK.;North West E‑Health (NWEH) Ltd, Manchester, UK.;King's College London, London, UK.;NIHR Biomedical Research Centre at Guy's and St Thomas' Hospitals London, London,;UK.;Intensive Care National Audit & Research Centre (ICNARC), London, UK.;York Trials Unit, Department of Health Sciences, The University of York, York,;Lancaster University, Lancaster, UK.;Health Research Authority, London, UK.;Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.;Department of Respiratory Epidemiology, Occupational Medicine and Public Health,;Imperial College London, London, UK.;NIHR Health Services & Delivery Programme, Southampton, UK.;NIHR Clinical Research Network, University of Leeds, Leeds, UK.;Department of Epidemiology and Population Health, London School of Hygiene &;Tropical Medicine, London, UK.;Division of Population & Behavioural Science, University of St. Andrews, St;Andrews, UK.;Department of Family & Community Medicine, University of Toronto, Toronto,;Ontario, Canada.;Department of Cardiovasular and Metabolic Medicine, Institute of Life Course and;Medical Sciences, University of Liverpool, Liverpool, UK.;Department of Health Data Science, University of Liverpool, Liverpool, UK.;Nuffield Department of Population Health, University of Oxford, Oxford, UK.;NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS;Foundation Trust, Oxford, UK.;Health Data Research UK, University of Oxford, Oxford, UK.;Health Data Research UK, London, UK.;University of Nottingham, Nottingham, UK.;Director of the NIHR Health Technology Assessment Programme (2015-2020),;Southampton, UK.;Clinical Practice Research Datalink, Medicines and Healthcare Products Regulatory;Agency, London, UK. |
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