Abstract #301712


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JSM 2002 Abstract #301712
Activity Number: 25
Type: Invited
Date/Time: Sunday, August 11, 2002 : 4:00 PM to 5:50 PM
Sponsor: ENAR
Abstract - #301712
Title: Statistical Issues in Alzheimer's Trial
Author(s): Kun Jin*+
Affiliation(s): Food and Drug Administration
Address: 5600 Fishers Lane, HFD-710, 15B45, Parklawn Bldg, Rockville, , Maryland, 20857, USA
Keywords: Clinical trial
Abstract:

In this talk, we will discuss some statistical issues encountered in regulatory actions on Alzheime'rs drug trials. We will also discuss some potential statistical challenges in the Alzheimer's trial design for future developments and labeling changes. The examples will be used to demonstrate that resolutions of subtle trial issues require a close interaction between the clinicians and the statisticians. Statisticians should always incorporate clinical and regulatory perspectives into their methodological developments.


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Revised March 2002