JSM 2004 - Toronto

Abstract #301617

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Activity Number: 220
Type: Contributed
Date/Time: Tuesday, August 10, 2004 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #301617
Title: Adjusting Significant Level for Interim Analysis Using Resampling Technique
Author(s): Yi-wen Ma*+ and Akiko Okamoto and Surya Mohanty
Companies: Johnson & Johnson Pharmaceutical R&D, LLC and Johnson & Johnson Pharmaceutical R&D, LLC and Johnson & Johnson Pharmaceutical R&D, LLC
Address: 1125 Trenton-Harbourton Rd., Titusville, NJ, 08560,
Keywords: significant level ; interim analysis ; resampling
Abstract:

Significance level adjustment for interim analysis in survival studies as well as power monitoring in survival studies utilize the asymptotic normality of log-rank type tests. The spending function methods of calculating nominal significance level relies on the possibility of constructing a Brownian motion from the test statistics stochastic process. Unlike linear models, there is a dependence relationship between interim subjects and later subjects. Unless this dependence is assumed to be ignorable, Brownian motion construction may not be feasible. Resampling methods will be utilized to assess the significance level. Comparison to traditional spending function methods also will be provided.

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