The changing landscape of data monitoring committees-Perspectives from regulators, members, and sponsors.
EMA
US FDA
adaptive design
clinical trial
data monitoring committee (DMC)
futility
regulatory guideline
Journal
Biometrical journal. Biometrische Zeitschrift
ISSN: 1521-4036
Titre abrégé: Biom J
Pays: Germany
ID NLM: 7708048
Informations de publication
Date de publication:
09 2019
09 2019
Historique:
received:
11
12
2017
revised:
30
11
2018
accepted:
02
12
2018
pubmed:
28
12
2018
medline:
9
4
2020
entrez:
28
12
2018
Statut:
ppublish
Résumé
Data Monitoring Committees (DMCs) are an integral part of clinical drug development. Their use has evolved along with changing study designs and regulatory expectations, which has associated statistical and ethical implications. Although there is guidance from the different regulatory agencies, there are opportunities to bring more consistency to address practical issues of establishing and operating a DMC. Challenging issues include defining the scope of DMC decisions, the regulatory requirements and expectations, the perceived independence of DMCs, the specific focus primarily on safety, etc. Wider use of adaptive clinical trial designs in recent years introduce additional challenges in terms of trial governance and the complexity of DMC activities. A panel comprised of clinical and statistical experts from across academia, industry, and regulatory agencies shared their experience and thoughts on the importance of these aspects and offered perspectives on the future of the DMCs. This paper documents the thinking from the panel session at the CEN-ISBS conference held in Vienna, Austria, 2017.
Identifiants
pubmed: 30589102
doi: 10.1002/bimj.201700307
doi:
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
1232-1241Informations de copyright
© 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
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