This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 256
Type: Contributed
Date/Time: Monday, August 2, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #309435
Title: Using Pilot Study for Clinical Study Planning
Author(s): Hongbin Gu*+ and Xiaofei Wang
Companies: The University of North Carolina at Chapel Hill and Duke University
Address: Dept of Psychiatry and Biostatistics, Chapel Hill, NC, 27517,
Keywords: pilot study ; clinical trial ; power and sample size

Standard clinical trial design based on pilot studies are associated with substantial probability of failed trials by launching trials when the true effect size is minimum or aborting trials when the true effect size is large. The presentation illustrated the bias embedded in conducting and utilizing pilot studies. It results in over-estimating true effect size, under-estimating sample size, reduced power and high failure rate. Several approaches were explored to address the issue, including internal pilots, a Bayesian estimator to adjust effect size estimate from pilot studies and adjustment to decision boundary for launching clinical trials. Simulation studies illustrated the performance of each approaches and explored the potential of extending the methodology to phamacogenetics studies.

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