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The Data Monitoring Committee: A Collective or a Collection?
Janet Wittes1, Thomas Fleming2, David DeMets3
1Wittes LLC, Washington, DC, USA. Janet@Wittesllc.com.
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.
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