Abstract #301929

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JSM 2002 Abstract #301929
Activity Number: 23
Type: Contributed
Date/Time: Sunday, August 11, 2002 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section*
Abstract - #301929
Title: Endpoint Change at the End of Trial
Author(s): Guoxing Soon*+
Affiliation(s): Food and Drug Administration
Address: 9201 Corporate Blvd., Rockville, MD, 20850, USA
Keywords:
Abstract:

Usually, the primary endpoint has to be pre-specified at the designing stage of the trial. For some trials, the choice of an appropriate primary endpoint at the designing stage is difficult because of great uncertainty in anticipated outcomes for different endpoints. This talk considers using a pre-specified procedure, based on the blinded outcome of the trial, to select the primary endpoint. I will examine the conditions for no inflation of type I error and proper statistical adjustment when an inflation of type I error is present. I will compare the power of this approach with the conventional approaches where the primary endpoint is pre-specified.

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Revised March 2002