The Data Monitoring Committee: A Collective or a Collection?
Publication
, Journal Article
Wittes, J; Fleming, T; DeMets, D; Ellenberg, S; Gerstein, H; Pfeffer, M; Rockhold, F; Yusuf, S; Hennekens, C
Published in: Therapeutic Innovation and Regulatory Science
July 1, 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.
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Published In
Therapeutic Innovation and Regulatory Science
DOI
EISSN
2168-4804
ISSN
2168-4790
Publication Date
July 1, 2023
Volume
57
Issue
4
Start / End Page
653 / 655
Related Subject Headings
- Statistics & Probability
- 4905 Statistics
- 3214 Pharmacology and pharmaceutical sciences
- 1117 Public Health and Health Services
- 0104 Statistics
Citation
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ICMJE
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NLM
Wittes, J., Fleming, T., DeMets, D., Ellenberg, S., Gerstein, H., Pfeffer, M., … Hennekens, C. (2023). The Data Monitoring Committee: A Collective or a Collection? Therapeutic Innovation and Regulatory Science, 57(4), 653–655. https://doi.org/10.1007/s43441-023-00520-6
Wittes, J., T. Fleming, D. DeMets, S. Ellenberg, H. Gerstein, M. Pfeffer, F. Rockhold, S. Yusuf, and C. Hennekens. “The Data Monitoring Committee: A Collective or a Collection?” Therapeutic Innovation and Regulatory Science 57, no. 4 (July 1, 2023): 653–55. https://doi.org/10.1007/s43441-023-00520-6.
Wittes J, Fleming T, DeMets D, Ellenberg S, Gerstein H, Pfeffer M, et al. The Data Monitoring Committee: A Collective or a Collection? Therapeutic Innovation and Regulatory Science. 2023 Jul 1;57(4):653–5.
Wittes, J., et al. “The Data Monitoring Committee: A Collective or a Collection?” Therapeutic Innovation and Regulatory Science, vol. 57, no. 4, July 2023, pp. 653–55. Scopus, doi:10.1007/s43441-023-00520-6.
Wittes J, Fleming T, DeMets D, Ellenberg S, Gerstein H, Pfeffer M, Rockhold F, Yusuf S, Hennekens C. The Data Monitoring Committee: A Collective or a Collection? Therapeutic Innovation and Regulatory Science. 2023 Jul 1;57(4):653–655.
Published In
Therapeutic Innovation and Regulatory Science
DOI
EISSN
2168-4804
ISSN
2168-4790
Publication Date
July 1, 2023
Volume
57
Issue
4
Start / End Page
653 / 655
Related Subject Headings
- Statistics & Probability
- 4905 Statistics
- 3214 Pharmacology and pharmaceutical sciences
- 1117 Public Health and Health Services
- 0104 Statistics