JSM 2004 - Toronto

Abstract #302232

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Activity Number: 347
Type: Luncheons
Date/Time: Wednesday, August 11, 2004 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #302232
Title: Utility of Flexible Designs in Drug Development? - SOLD OUT
Author(s): H.M. James Hung*+
Companies: U.S. Food and Drug Administration
Address: DB1, CDER, Rockville, MD, 20852,
Keywords:
Abstract:

A number of flexible designs have been proposed in statistical literature. Most of them embed multiple stage planning. The concept of multiple stage planning seems natural. How should such stepwise planning fit in the current framework of the three-phase clinical trials? What are anticipated obstacles needing resolution? What are the issues with statistical inference for the data resulted from such designs?


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Revised March 2004