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The Data Monitoring Committee: A Collective or a...
Journal article

The Data Monitoring Committee: A Collective or a Collection?

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 …

Authors

Wittes J; Fleming T; DeMets D; Ellenberg S; Gerstein H; Pfeffer M; Rockhold F; Yusuf S; Hennekens C

Journal

Therapeutic Innovation & Regulatory Science, Vol. 57, No. 4, pp. 653–655

Publisher

Springer Nature

Publication Date

July 2023

DOI

10.1007/s43441-023-00520-6

ISSN

2168-4790