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Forming Your Phase III Trial's Data and Safety Monitoring Board: A Perspective on Safety
  1. Janet Wittes
  1. From Statistics Collaborative, Washington, DC.
  2. Address correspondence to: Dr. Janet Wittes, Statistics Collaborative, 1710 Rhode Island Avenue, NW, Washington, DC 20036; e-mail: janet{at}statcollab.com.

Abstract

A data safety monitoring board (DSMB) established in a phase III trial to monitor the safety of participants in a clinical trial views itself as protecting participants and ensuring the integrity of the study. The DSMB should operate under a clear charter, with expectations understood by all members of the Board, the sponsor, and the investigators. Sponsors must trust their DSMBs. The sponsor must give the DSMB the tools and the data that it needs to operate effectively in protecting the safety of the participants.

Key Words
  • clinical trials
  • data safety monitoring boards
  • safety monitoring

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