The Data Monitoring Committee: A Collective or a Collection?
Data monitoring committee
Electronic recording
Interim analysis
Minutes
Randomized controlled trials
Safety
Journal
Therapeutic innovation & regulatory science
ISSN: 2168-4804
Titre abrégé: Ther Innov Regul Sci
Pays: Switzerland
ID NLM: 101597411
Informations de publication
Date de publication:
Jul 2023
Jul 2023
Historique:
received:
27
01
2023
accepted:
30
03
2023
medline:
19
6
2023
pubmed:
18
4
2023
entrez:
17
4
2023
Statut:
ppublish
Résumé
In this commentary, we urge that a Data Monitoring Committee (DMC) should operate as a collective, that is, as a unitary whole. In so doing, its recommendations should emerge through a consensus development process, not through a vote of the members. The summary notes of its closed session, that is, its minutes, should report the recommendations of the DMC and, if necessary, the justification for those recommendations; it should not attribute opinions to individual members. Importantly, the proceedings of the DMC meetings should not be electronically recorded.
Identifiants
pubmed: 37069466
doi: 10.1007/s43441-023-00520-6
pii: 10.1007/s43441-023-00520-6
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
653-655Subventions
Organisme : National Institute of Health
ID : R37-AI29168
Informations de copyright
© 2023. The Author(s), under exclusive licence to The Drug Information Association, Inc.
Références
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