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: 156
Type: Roundtables
Date/Time: Monday, July 30, 2007 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #310174
Title: Evaluating Probability of Success for Internal Decisionmaking in Early Drug Development
Author(s): Narinder Nangia*+
Companies: Abbott Laboratories
Address: 100 Abbott Park Road, Abbott Park, IL, 60064-6124,
Keywords: Bayesian ; Clinical Trials ; Early Drug Development ; Probability of Success ; Inflammation ; Oncology
Abstract:

There is a need to look beyond p-values in drawing meaningful inference from the analysis of phase I-II (learning stage) clinical trials data. This discussion will be on using the Bayesian approach to exploit totality of accumulated data/knowledge in a formal way for internal decisionmaking in early drug development. Examples from inflammation and oncology therapeutic areas will be considered for evaluation of probability of success for drug candidates in meeting the target product profile.


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Revised September, 2007