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Realising the full potential of data-enabled trials in the UK: a call for action
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 col...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8211043/ https://www.ncbi.nlm.nih.gov/pubmed/34135032 http://dx.doi.org/10.1136/bmjopen-2020-043906 |
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author | 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 |
author_facet | 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 |
author_sort | Sydes, Matthew R |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-8211043 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-82110432021-07-01 Realising the full potential of data-enabled trials in the UK: a call for action 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 BMJ Open Health Informatics 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. BMJ Publishing Group 2021-06-16 /pmc/articles/PMC8211043/ /pubmed/34135032 http://dx.doi.org/10.1136/bmjopen-2020-043906 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Health Informatics 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 Realising the full potential of data-enabled trials in the UK: a call for action |
title | Realising the full potential of data-enabled trials in the UK: a call for action |
title_full | Realising the full potential of data-enabled trials in the UK: a call for action |
title_fullStr | Realising the full potential of data-enabled trials in the UK: a call for action |
title_full_unstemmed | Realising the full potential of data-enabled trials in the UK: a call for action |
title_short | Realising the full potential of data-enabled trials in the UK: a call for action |
title_sort | realising the full potential of data-enabled trials in the uk: a call for action |
topic | Health Informatics |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8211043/ https://www.ncbi.nlm.nih.gov/pubmed/34135032 http://dx.doi.org/10.1136/bmjopen-2020-043906 |
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