JSM 2011 Online Program

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Abstract Details

Activity Number: 160
Type: Topic Contributed
Date/Time: Monday, August 1, 2011 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #302607
Title: Adaptive Design with Some Practical Issues
Author(s): Bo Yang*+
Companies: Merck & Co., Inc.
Address: 2015 Galloping Hill Rd, Kenilworth, NJ, 07033,
Keywords: adaptive design ; clinical trial ; interim monitoring
Abstract:

In recent years, adaptive design methods have attracted much attention in clinical research due to its flexibility and efficiency. If use properly, adaptive approaches could facilitate early identification of therapeutic effects, conserve patient resources for treatments that have a higher probability of success or minimize patient exposure to ineffective treatments. However, adaptive designs are not without issues. Such designs may be more prone to bias in the interpretation of the results due to close monitoring and changes implemented based on the interim results. In this talk, we will review some of the practical issues that are commonly encountered when implementing adaptive design methods in clinical trials.


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