Issues in Phase I Drug Development
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*Dennis Cosmatos, Wyeth  *Jeetu Ganju, Amgen  *Fang Liu, Merck  *Charles Locke, Abbott  *Xiaoling Meng, sanofi-aventis  *Venkat Sethuraman, Novartis  *Hao Zhu, Pharmacometrics, FDA 


Phase I clinical trials have a unique set of challenges as compared to trials conducted in later phases of development. Besides having different objectives, study designs, and endpoints, the regulatory review of this work is performed by different groups than those reviewing statistics for later phase studies. Most literature concerning statistical aspects of drug development are focused on these later phases. This may have the effect of decisions for late stage clinical trials being assumed appropriate for Ph I without considering these inherent differences. This session will present the results of a survey designed by statisticians representing Ph I groups at no fewer than 6 pharmaceutical/biotech companies asking each company to summarize their approach to several technical questions for handling Ph I statistical aspects in drug development. A complete summary will be presented in hand-outs while issues found to be more disparate in their answers or more controversial will be focused on during the session. The statisticians responsible for the questions and answers will compose a panel for briefly presenting these particular topics and for discussion. Topics include analysis of missing data in crossover studies, unbinding of the sponsor while studies are on-going, multiplicity considerations, PK/PD modeling, and calculating power. An FDA representative will also participate providing personal insight but will not necessary represent the FDA's viewpoint. Audience participation is encouraged.