TY - JOUR

T1 - Realising the full potential of data-enabled trials in the UK

T2 - A call for action

AU - The Data Enabled Trials Group Workshop Group

AU - Sydes, M.R.

AU - Barbachano, Y.

AU - Bowman, L.

AU - Denwood, T.

AU - Farmer, A.

AU - Garfield-Birkbeck, S.

AU - Gibson, M.

AU - Gulliford, M.C.

AU - Harrison, D.A.

AU - Hewitt, C.

AU - Logue, J.

AU - Navaie, W.

AU - Norrie, J.

AU - O'Kane, M.

AU - Quint, J.K.

AU - Rycroft-Malone, J.

AU - Sheffield, J.

AU - Smeeth, L.

AU - Sullivan, F.

AU - Tizzard, J.

AU - Walker, P.

AU - Wilding, J.

AU - Williamson, P.R.

AU - Landray, M.

AU - Morris, A.

AU - Walker, R.R.

AU - Williams, H.C.

AU - Valentine, J.

PY - 2021/6/30

Y1 - 2021/6/30

N2 - 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.

AB - 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.

KW - clinical trials

KW - health informatics

KW - statistics & research methods

KW - human

KW - patient selection

KW - United Kingdom

KW - COVID-19

KW - Humans

KW - Patient Selection

KW - SARS-CoV-2

U2 - 10.1136/bmjopen-2020-043906

DO - 10.1136/bmjopen-2020-043906

M3 - Journal article

VL - 11

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 6

M1 - e043906

ER -