JSM 2011 Online Program

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Abstract Details

Activity Number: 500
Type: Topic Contributed
Date/Time: Wednesday, August 3, 2011 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #301378
Title: Can We Have a Self-Reliant Sample Size Modification in Clinical Trials?
Author(s): Jin Wang*+
Companies: Abbott Vascular
Address: 3200 lakeside drive, santa clara, CA, 95054,
Keywords: adaptive design ; sampling ; sample size ; type I error
Abstract:

In clinical trial methodology development, recent years have seen many statistical techniques developed so that mid-course sample size modification based on the interim treatment effect can be carried out without inflating the type I errors. However, logistic challenges still exist to implement these modifications due to the planning for the new enrollment and its associated bias concerns. In this paper, an attempt has been made to explore the re-sampling approaches so that the need for additional sample size increase might be based on a random sample from the originally planned subject set. Simulations are conducted to understand the behavior of these approaches and some discussions are provided.


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