JSM 2005 Online Program

Abstract #303056

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:	218
Type:	Topic Contributed
Date/Time:	Tuesday, August 9, 2005 : 8:30 AM to 10:20 AM
Sponsor:	Biometrics Section
Abstract - #303056
Title:	Innovative Designs and Analysis of Clinical Trials
Author(s):	Yu Shen*+
Companies:	The University of Texas M. D. Anderson Cancer Center
Address:	1515 Holcombe Blvd, Houston, TX, 77030, United States
Keywords:	Bayesian ; Adaptive ; Clinical Trial
Abstract:	A Bayesian adaptive design is proposed for clinical trial using decision theoretical approaches. A loss function is specified to consider the cost for each patient and the costs of making incorrect decisions at the end of a trial. At each interim analysis, the decision to terminate or continue the trial is based on the expected loss function while concurrently incorporating efficacy, futility, and cost. The maximum number of interim analyses is not prefixed, but decided adaptively by the observed data. We derive explicit connections between the loss function and the frequentist error rates so the desired frequentist properties can be maintained for regulatory settings. The operating characteristics of the design can be evaluated on frequentist grounds. Extensive simulations are carried out to compare the proposed design with existing ones. The design is general enough to accommodate both continuous and discrete types of data.

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