|
Activity Number:
|
395
|
|
Type:
|
Invited
|
|
Date/Time:
|
Thursday, August 15, 2002 : 10:30 AM to 12:20 PM
|
|
Sponsor:
|
Biometrics Section*
|
| Abstract - #300027 |
|
Title:
|
PI & DSMB Responsibilities in Randomized Clinical Trials
|
|
Author(s):
|
Eric Rose*+ and Jeffrey Silber*+ and William Friedewald*+ and Curtis Meinert*+ and Robert O'Neill*+
|
|
Affiliation(s):
|
Columbia University and University of Pennsylvania and Columbia University and Johns Hopkins University and Food and Drug Administration
|
|
Address:
|
Columbia-Presbyterian Medical Center , New York , New York, 10032, USA 3535 Market Street, Suite 1029 , Philadelphia , Pennsylvania, 19104, USA 622 W. 168th Street, PH 18W, New York, New York, 10032, USA 615 N. Wolfe Street, Baltimore , Maryland, 21205, USA 5600 Fishers Lane, Rockville, Maryland, 28057, USA
|
|
Keywords:
|
|
|
Abstract:
|
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.
|
- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
Back to the full JSM 2002 program |
