JSM Preliminary Online Program
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Activity Number: 448
Type: Invited
Date/Time: Wednesday, August 9, 2006 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304909
Title: Considerations in Use of Adaptive Designs in Drug Development
Author(s): Hsien-Ming Hung*+
Companies: U.S. Food and Drug Administration
Address: 10993 New Hampshire Ave., Bldg. 22, Room 4238, Silver Spring, MD, 20993-0002,
Keywords: adaptive design ; flexible design ; estimation ; practicality ; logistics ; statistical testing
Abstract:

In the last decade, a great deal of research has been devoted to adaptive or flexible designs, particularly multistage designs, in the statistical literature. The concept behind multistage designs seems natural in dealing with the complex problems in drug development. Statistical methodology is well-developed for testing the effect of a test drug. In this talk, we will give an overview on the essence of statistical testing under such designs. Then, we will share our insights on the estimation problem and point out other problems, such as logistics and practicality, when such designs are used.

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Revised April, 2006