Adaptive Designs for Clinical Trials FDA / HST Workshop

Main Category: Public Health
Article Date: 08 Aug 2004 - 0:00 PDT

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FDA and the Harvard-MIT Division of Health Sciences and Technology, are co-sponsoring a one-day workshop on October 19 entitled "Adaptive Clinical Trial Designs: Ready for Prime Time?" Speakers and panelists from academia, industry and FDA will present and discuss the potential advantages and downsides of recently proposed new designs that have been advocated as offering increased flexibility in drug development. Topics for this workshop include:

-- Differences between new types of adaptive designs and more traditional designs that permit early stopping

-- Potential advantages and disadvantages of new adaptive designs

-- Regulatory perspective on use of adaptive designs

The workshop is aimed at those involved in planning clinical trials programs, and those involved in designing, conducting and analyzing clinical trials.

University of Maryland, Shady Grove Campus
Gaithersburg, MD
October 19, 2004

Speakers and Panelists

-- Christy Chuang-Stein, Pfizer, Inc.
-- Ralph B. D'Agostino, Boston University
-- Susan S. Ellenberg, FDA
-- Scott Emerson, University of Washington
-- Thomas R. Fleming, University of Washington
-- Howard J. Golub, Carestat, Inc.
-- Hsien-Ming James Hung, FDA
-- Cyrus R. Mehta, Cytel Software Corporation
-- Jay P. Siegel, Centecor, Inc.
-- Robert Temple, FDA
-- Anastasios (Butch) Tsiatis, North Carolina State University

Additional Information and Registration

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