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