JSM 2005 Online Program

Abstract #303916

This is the preliminary program for the 2005 Joint Statistical Meetings in Minneapolis, Minnesota. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2005); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

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Activity Number:	389
Type:	Topic Contributed
Date/Time:	Wednesday, August 10, 2005 : 10:30 AM to 12:20 PM
Sponsor:	Biopharmaceutical Section
Abstract - #303916
Title:	Multiple Inferences in Early Phase II Clinical Trials: Performance of Exact Methods for Dose Response
Author(s):	Alok Krishen*+ and Rafe Donahue
Companies:	GlaxoSmithKline and GlaxoSmithKline
Address:	5 Moore Drive, RTP, NC, 27709, United States
Keywords:	Multiplicity ; Phase II ; Clinical Trials
Abstract:	Little attention has been given to the formal aspects of multiple inference-making from early phase clinical trials data. After initial new drug testing in healthy humans (phase I), the focus turns to establishing efficacy, dose, and safety in patients (phase II). The number of patients exposed to drug at this stage is kept small by design; individual dose levels may include only a dozen or fewer patients. Thus, the statistical methods based on large sample theory are not necessarily applicable and might give misleading results. We will report on the performance of exact (nonlarge-sample) methods for making multiple between-treatment group comparisons to establish dose response and study the use of exploratory methods for making multiple comparisons. Simulation studies will be used to compare analysis methodologies across several dose response situations typically found in early phase II trials.

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