JSM Preliminary Online Program
This is the preliminary program for the 2007 Joint Statistical Meetings in Salt Lake City, Utah.

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Activity Number: 273
Type: Topic Contributed
Date/Time: Tuesday, July 31, 2007 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #308984
Title: Flexible Designs in Clinical Trials: Case studies
Author(s): Ning Li*+
Companies: Food and Drug Administration
Address: , Rockville, MD, 20850,
Keywords: Felxible designs ; Clinical trials
Abstract:

The standard approach to design and analysis of confirmative clinical studies is to pre-specify all design features, including the primary endpoints and the test statistics. However, in flexible trial design, some flexibility to modify the pre-specified design features during the course of study is offered. Consequently, the trial sponsors may face variety of challenges to maintain the integrity and credibility of trials performed. In this talk, several real-scenarios cases of adaptive designed trials will be presented. The implicit and explicit impacts of the modifications on trial results/interpretations will be discussed.

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Revised September, 2007