The Data Monitoring Committee: A Collective or a Collection?
Overview
Overview
Journal
Ther Innov Regul Sci
Specialties
General Medicine
Pharmacology
Pharmacology
Date
2023 Apr 17
PMID
37069466
Authors
Authors
Affiliations
Affiliations
Soon will be listed here.
Abstract
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.
References
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