This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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504
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 4, 2010 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #306645 |
Title:
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Flexible Modification of Survival Trials
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Author(s):
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Mikhail P. Salganik*+ and Cyrus R. Mehta
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Companies:
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Cytel Inc.
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Address:
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675 Massachusetts Avenue, Cambridge, MA, 02139-3309,
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Keywords:
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Survival ;
Flexible ;
Adaptive ;
Trial
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Abstract:
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In clinical trials with survival outcomes investigators may sometimes be allowed to increase the accrual duration, accrual rate and duration of a trial if the results of the interim analysis "look promising". Several possible approaches to the design of these adaptive trials have been developed (e.g. Li, Shih, and Wang, 2005, Wassmer , 2006). In theory the investigator/sponsor is allowed nearly complete flexibility in modifying the on-going trial without compromising the type I error. In practice the implementation of the adaptive designs often relies on pre-specification of the adaptation algorithm in the protocol. We discuss the implementation of the adaptive design that allows sponsor to retain substantial influence over the adaptation process without un-blinding the data to the sponsor. We will illustrate the method with an actual clinical trial.
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