JSM Activity #395

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Activity ID:  395
Title
PI and DSMB Responsibilities in Randomized Clinical Trials
Date / Time / Room Sponsor Type
08/15/2002
10:30 AM - 12:20 PM
Room: S-Royal Ballroom A 		Biometrics Section*, Biopharmaceutical Section* Invited
Organizer: Daniel F. Heitjan, Columbia University
Chair: Annetine C. Gelijns, Columbia University
Discussant:  
Floor Discussion 12:10 PM
Description

Originally, the data and safety monitoring board (DSMB) was conceived as a means of providing objective backup in the review of safety and interim efficacy data in clinical trials. It is our impression that as DSMBs have proliferated, their role has also changed; in some cases they serve not as trial advisors but as de facto governing boards, and their mandate and influence may continue even when the final interim analysis has been completed. Trial principal investigators (PIs) may consequently find themselves in the dark and powerless, as the DSMB makes critical decisions regarding the conduct of the trial. This session will bring together a panel of experienced clinical researchers and statisticians to discuss this issue. The fundamental issue for debate is the allocation of responsibility, power and accountability among the PI, the sponsor and the DSMB. The panel will talk about how things used to be, how things are now (and how they got that way), and where things are (or should be) going.
  300027  By:  Eric Rose ,  Jeffrey Silber ,  William Friedewald ,  Curtis Meinert ,  Robert O'Neill 10:35 AM 08/15/2002
PI & DSMB Responsibilities in Randomized Clinical Trials

JSM 2002

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Revised March 2002