JSM Activity #129


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Activity ID:  129
Title
* ! Adaptive Sample-Size Considerations in the Presence of Unknown Treatment Effect and Nuisance Parameters
Date / Time / Room Sponsor Type
08/12/2002
2:00 PM - 3:50 PM
Room: H-West Ballroom
Biopharmaceutical Section*, International Indian Statisticial Association, WNAR Invited
Organizer: Cyrus Mehta, Cytel Software Corporation
Chair: Anastasios A. Tsiatis, North Carolina State University
Discussant: 3:25 PM - Kuang-Kuo G. Lan, Pfizer, Inc.    
Floor Discussion 3:40 PM
Description

There has been considerable recent interest in achieving greater flexibility in sample size calculations at the design stage of a study, either because the sponsor is very uncertain about the underlying effect size or because of uncertainty about nuisance parameters like variance, baseline response rate or baseline hazard rate. Adaptive sample size calculations that preserve the type-1 error and power are possible in both settings, especially in conjunction with group sequential clinical trials where the data are monitored routinely anyway. However, such adaptive designs raise important technical and philosophical questions that warrant discussion.This session will present some of the latest research on this topic by researchers from industry, academia, the NIH and the FDA. The discussant is an acknowledged leader in this field.
  300589  By:  H.M. James Hung 2:05 PM 08/12/2002
Adaptive Statistical Inference Following Sample Size Modification Based on Interim Review of Effect Size

  300082  By:  Mike  Proschan 2:25 PM 08/12/2002
Practical Mid-Course Sample Size Modification In Clinical Trials

  300083  By:  Cyrus  Mehta 2:45 PM 08/12/2002
Flexible Sample Size Considerations Using Information Based Interim Monitoring

  300260  By:  Christopher  Jennison 3:05 PM 08/12/2002
Flexible Sample Size: Still No Free Lunch!

JSM 2002

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Revised March 2002