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The Data Monitoring Committee: A Collective or a Collection?

Janet Turk WittesThomas FlemingDavid DeMetsSusan EllenbergHertzel GersteinMarc PfefferFrank RockholdSalim YusufCharles Hennekens
Published in: Therapeutic innovation & regulatory science (2023)
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.
Keyphrases
  • clinical practice
  • electronic health record
  • big data
  • high intensity
  • artificial intelligence
  • deep learning
  • data analysis