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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Funding
Work on this article by Dr. Fleming was supported by National Institutes of Health (NIH) grant R37-AI29168. The other authors declare no receipt of financial support for the research, authorship, or publication of this article.
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JW drafted the document. All authors contributed to the writing and review of the manuscript.
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The authors have been or currently are members of various DMCs; however, we do not consider participation in DMCs to constitute a conflict of interest with the current commentary.
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Wittes, J., Fleming, T., DeMets, D. et al. The Data Monitoring Committee: A Collective or a Collection?. Ther Innov Regul Sci 57, 653–655 (2023). https://doi.org/10.1007/s43441-023-00520-6
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DOI: https://doi.org/10.1007/s43441-023-00520-6