CAN BAYESIAN APPROACHES TO STUDYING NEW TREATMENTS IMPROVE REGULATORY DECISION-MAKING?

Masur Auditorium, NIH
May 20-21, 2004

Flyer (PDF 253 KB)

Program

Target Audience: FDA reviewers and managers, industry, and academia, statisticians and non-statisticians.

Goals:

Communicate the underlying concepts of Bayesian design and analysis of clinical trials in non-technical terms.
Illustrate the use of Bayesian approaches to clinical trials with case studies.
Demonstrate how a Bayesian approach uses evidence in the decision making process.
Review the experience of the Center for Devices and Radiological Health using Bayesian approaches and discuss the potential for application of Bayesian approaches in clinical trials of investigational pharmaceuticals.
Discuss how studies using a Bayesian approach can satisfy regulatory requirements.

Day 1	Chairperson Susan Ellenberg
8:15 - 8:25	FDA Introductory Comments - Lester Crawford
8:25 - 8;35	JHU Introductory Comments - Scott Zeger
8:35 - 8:55	Introduction of Workshop Objectives and Format - Susan Ellenberg
8:55 - 9:05	FDA Issues on Clinical Studies Design and Evaluation - Janet Woodcock
9:05 - 9:35	How FDA Currently Makes Decisions on Clinical Studies - Bob Temple and David Feigal
9:35 - 10:00	Basic Bayesian I - Steve Goodman
10:00 - 10:30	Break
10:35 - 11:45	Basic Bayesian II (use and interpretation of Bayesian tools in design and analysis) - Tom Louis and Don Berry
11:45 - 12:15	Floor Discussion (All previous speakers)
12:15 - 1:45	Lunch
1:45 - 2:00	Framework for Case Study Presentations - Larry Kessler
2:00 - 3:20	Case Study 1 - Moderator - Larry Kessler Clinical/Statistician Views (45 min) - John Sladky and Steve Goodman Panel Discussion of Case Study 1 (35 min) J. Greenhouse, Peter Lachenbruch, Larry Gould, David Cornblath, Russell Katz
3:20 - 3:40	Break
3:40 - 5:00	Case Study 2 - Greg Campbell, Moderator Clinical/Statistician Views (45 min) Bailey Lipscomb, Don Berry, Guarong Ma Panel Discussion of Case Study 2 (35 min) Telba Irony, Celia Witten, Constantine Gatsonis, Janet Wittes
5:00 - 7:00	Reception/networking

Day 2
8:00 - 9:20	Case Study 3 - Chuck Anello, Moderator Clinical/Statistician Views (45 min) Andy Grieve and Mike Karms Panel Discussion of Case Study 3 (35 min) Richard Simon, Marc Walton, Bob O'Neill, Gary Koch, Bill DuMouchel, Frank Rockhold
9:40 - 10:15	CDRH Experience with Bayesian Strategies - Greg Campbell
10:15 - 10:45	Break
10:55 - 11:55	Panel Discussion - Statistical Issues Norris Alderson, Moderator Don Rubin, Ralph D'Agostino, Jay Siegel, Stacy Lindborg, Susan Ellenberg, Bob O'Neill, Greg Campbell
11:55 - 1:00	Panel Discussion - Janet Woodcock, Jesse Goodman, David Feigal, Stephen Sundlof, Bob Temple
1:00 - 1:05	Close

For registration information, please go to: http://www.jhu.edu/advanced/bayesian/

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CAN BAYESIAN APPROACHES TO STUDYING NEW TREATMENTS IMPROVE REGULATORY DECISION-MAKING?

Sponsored by the Food and Drug Administration and Johns Hopkins University

Masur Auditorium, NIH May 20-21, 2004

Flyer (PDF 253 KB)

Program

Masur Auditorium, NIH
May 20-21, 2004