Medicines and Healthcare products Regulatory Agency’s “Consultation on proposals for legislative changes for clinical trials”: a response from the Trials Methodology Research Partnership Adaptive Designs Working Group, with a focus on data sharing

URN zum Zitieren dieses Dokuments:

urn:nbn:de:bvb:355-epub-777968 Copy

DOI zum Zitieren dieses Dokuments:

10.5283/epub.77796 Copy

Law, Martin ; Couturier, Dominique-Laurent ; Choodari-Oskooei, Babak ; Crout, Phillip ; Gamble, Carrol ; Jacko, Peter ; Pallmann, Philip ; Pilling, Mark ; Robertson, David S. ; Robling, Michael ; Sydes, Matthew R. ; Villar, Sofía S. ; Wason, James ; Wheeler, Graham ; Williamson, S. Faye ; Yap, Christina ; Jaki, Thomas

Lizenz: Creative Commons Namensnennung 4.0 International PDF - Veröffentlichte Version (852kB)

Veröffentlichungsdatum dieses Volltextes: 23 Sep 2025 09:19

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Details

Dokumentenart:	Artikel
Open Access Art:	CC-Lizenz
Titel eines Journals oder einer Zeitschrift:	Trials
Verlag:	Springer Nature
Band:	24
Seitenbereich:	S. 640
Datum:	5 Oktober 2023
Institutionen:	Informatik und Data Science > Fachbereich Maschinelles Lernen und Data Science > Chair for Computational Statistics (Prof. Dr. Thomas Jaki)
Sonstige Projekte:	UK MRC, MC_UU_00002/15, UK MRC, MC_UU_12023/29, UK MRC, MC_UU_00004/08, UK MRC, MC_UU_00002/14, Health and Care Research Wales, Cancer Research UK
Identifikationsnummer:	Wert Typ 10.1186/s13063-023-07576-7 DOI
Stichwörter / Keywords:	Consultation Data sharing Legislation
Dewey-Dezimal-Klassifikation:	000 Informatik, Informationswissenschaft, allgemeine Werke > 004 Informatik
Status:	Veröffentlicht
Begutachtet:	Ja, diese Version wurde begutachtet
An der Universität Regensburg entstanden:	Zum Teil
Dokumenten-ID:	77796

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Zusammenfassung

In the UK, the Medicines and Healthcare products Regulatory Agency consulted on proposals “to improve and strengthen the UK clinical trials legislation to help us make the UK the best place to research and develop safe and innovative medicines”. The purpose of the consultation was to help finalise the proposals and contribute to the drafting of secondary legislation. We discussed these proposals ...

Zusammenfassung

In the UK, the Medicines and Healthcare products Regulatory Agency consulted on proposals “to improve and strengthen the UK clinical trials legislation to help us make the UK the best place to research and develop safe and innovative medicines”. The purpose of the consultation was to help finalise the proposals and contribute to the drafting of secondary legislation. We discussed these proposals as members of the Trials Methodology Research Partnership Adaptive Designs Working Group, which is jointly funded by the Medical Research Council and the National Institute for Health and Care Research. Two topics arose frequently in the discussion: the emphasis on legislation, and the absence of questions on data sharing. It is our opinion that the proposals rely heavily on legislation to change practice. However, clinical trials are heterogeneous, and as a result some trials will struggle to comply with all of the proposed legislation. Furthermore, adaptive design clinical trials are even more heterogeneous than their non-adaptive counterparts, and face more challenges. Consequently, it is possible that increased legislation could have a greater negative impact on adaptive designs than non-adaptive designs. Overall, we are sceptical that the introduction of legislation will achieve the desired outcomes, with some exceptions. Meanwhile the topic of data sharing — making anonymised individual-level clinical trial data available to other investigators for further use — is entirely absent from the proposals and the consultation in general. However, as an aspect of the wider concept of open science and reproducible research, data sharing is an increasingly important aspect of clinical trials. The benefits of data sharing include faster innovation, improved surveillance of drug safety and effectiveness and decreasing participant exposure to unnecessary risk. There are already a number of UK-focused documents that discuss and encourage data sharing, for example, the Concordat on Open Research Data and the Medical Research Council’s Data Sharing Policy. We strongly suggest that data sharing should be the norm rather than the exception, and hope that the forthcoming proposals on clinical trials invite discussion on this important topic.

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