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Data and Safety Monitoring Boards: Some Enduring Questions

Published online by Cambridge University Press:  01 January 2021

Charles J. Kowalski  and
Jan L. Hewett
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Extract

Data Safety and Monitoring Boards (DSMBs) were introduced in the 1960s to monitor data in clinical trials to ensure subject safety. It was thought important that DSMB members be experts in the field(s) of interest, but not otherwise involved in the study (e.g., sponsors and investigators) in order to maximize objectivity. Since then, the use of DSMBs has increased dramatically, and their scope has expanded to include scientific issues — in particular, to avoid bias that can result when trials are stopped early because of evidence that one treatment has greater efficacy or causes greater harm than another; or that no treatment is likely to do better than any other.

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Independent
Information
Journal of Law, Medicine & Ethics , Volume 37 , Issue 3 , Fall 2009 , pp. 496 - 506
Copyright
Copyright © American Society of Law, Medicine and Ethics 2009

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References

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