JSM Preliminary Online Program
This is the preliminary program for the 2007 Joint Statistical Meetings in Salt Lake City, Utah.

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Activity Number: 37
Type: Other
Date/Time: Sunday, July 29, 2007 : 4:00 PM to 5:50 PM
Sponsor: ASA
Abstract - #308145
Title: When Would I Consider Adaptive Design for Late-Stage Development?
Author(s): Keaven M. Anderson*+
Companies: Merck & Co., Inc.
Address: Clinical Biostatistics and Research Decision Sciences, West Point, PA, 19486-0004,
Keywords: adaptive design ; clinical trials ; Phase II/III
Abstract:

This talk is based on primarily on past experiences for specific trials where adaptation was found to be useful. A primary consideration is whether or not there is time to do adaptation given the speed of enrollment and delays due to patient follow-up, data entry, data cleaning, analysis and decision making. How much information adaptation reveals and its affect on regulatory acceptance must be considered. Specific adaptations will include fully sequential analysis for safety issues, group sequential design and use of information-based timing of analyses, adaptive sample size re-estimation, dropping of arms and efficiency issues. Another area that will be discussed is examples from Phase II/III combination studies in oncology. In addition to adapting within a trial, using limited interim information to make other decisions related to product development will be discussed.

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Revised September, 2007