JSM 2005 Online Program

JSM Activity #CE_08C

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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The Program has labeled the meeting rooms with "letters" preceding the name of the room, designating in which facility the room is located:

Minneapolis Convention Center = “MCC” Hilton Minneapolis Hotel = “H” Hyatt Regency Minneapolis = “HY”

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CE_08C	Sun, 8/7/05, 8:00 AM - 4:00 PM	MCC-L100 G
Adaptive Bayesian Clinical Trials - Continuing Education - Course
ASA, Section on Bayesian Statistical Science, Biopharmaceutical Section
Instructor(s): Scott M. Berry, Berry Consultants LLC, Donald A. Berry, The University of Texas M. D. Anderson Cancer Center
We will describe recent Bayesian innovations in the design and analysis of clinical trials. The goals are (i) more efficient clinical trials and clinical development programs, and (ii) treating patients more effectively, both those in and those outside of trials. Innovative trial designs have been effected at the University of Texas M. D. Anderson Cancer Center, in national oncology studies and in pharmaceutical and medical device industry-sponsored trials. We will provide some background on Bayesian designs for clinical trials and give several case studies of the Bayesian adaptive approach used in actual designs and analyses presented to the FDA. These examples include the possibility of early stopping, seamless phases II and III trials with sequential sampling, using early endpoints to guide sample size and early stopping, and dose finding. The cost savings of such an approach are usually substantial. The only prerequisite knowledge necessary is a basic understanding of statistics and of clinical trials.