JSM Activity #64


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Activity ID:  64
Title
* ! Practical Aspects of Adaptive Designs in Clinical Trials
Date / Time / Room Sponsor Type
08/12/2002
8:30 AM - 10:20 AM
Room: H-West Ballroom
Biometrics Section*, Biopharmaceutical Section*, ENAR Topic Contributed
Organizer: Paul Gallo, Novartis Pharmaceuticals
Chair: Paul Gallo, Novartis Pharmaceuticals
Discussant: 9:55 AM - Lloyd Fisher, University of Washington    
Floor Discussion 10:15 AM
Description

During the past decade, considerable progress has been made in developing designs for clinical trials which can provide robustness against incorrect initial assumptions, reduce the number of patients exposed to inefficient or even hazardous treatments, and increase the changes for tials to provide conclusive results. These designs allow knowledge gained from the accumulating information to be used for implementing data-driven modifications during a trial, and are called adaptive, flexible, or self-learning. The challenge is to guarantee in a frequentist framework that predefined levels of hypothesis tests are maintained even if important design features are modified. Such features may include, in addition to termination of a trial or of treatment arms at interim analyses, the following: sample size reassessments, adaption of test statistics (e.g., weights in contrasts), modification of multiple testing strategies, change of primary efficacy parameters, or changes in inclusion / exclusion criteria. The aim of this session is to present an integrated overview of recent developments in this area, both in Europe and the U.S., and in particular to discuss practical aspects in the design, conduct, and analysis of adaptive clinical trials, as well as in estimation and decision making.
  300134  By:  Gernot  Wassmer 8:35 AM 08/12/2002
Data-Driven Analysis Strategies for Proportion Studies in Adaptive Group Sequential Test Designs

  300135  By:  Peter  Bauer 8:55 AM 08/12/2002
Multiple Decision Making in Adaptive Designs

  300136  By:  Qing  Liu 9:15 AM 08/12/2002
General Two-Stage Adaptive Designs With Dependent Data

  300510  By:  Yu   Shen 9:35 AM 08/12/2002
Sample Size Re-estimation for Clinical Trials with Censored Survival Data

JSM 2002

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Revised March 2002