Abstract #302000

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JSM 2003 Abstract #302000
Activity Number: 470
Type: Contributed
Date/Time: Thursday, August 7, 2003 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section
Abstract - #302000
Title: Sample Size and Power in Survival Changepoint model
Author(s): Ramin B. Arani*+ and Youn C. Park and Seng-Jaw Soong
Companies: Johnson & Johnson Pharmaceutical Research and Development, LLC and Johnson & Johnson Pharmaceutical Research and Development, LLC and University of Alabama
Address: 1125 Trenton-Harbourton Rd., Titusville, NJ, 08560,
Keywords: changepoint ; bootstrap method ; logistic model
Abstract:

In designing studies with survival endpoint, the underlying assumption for determining sample size is having constant hazard. However, often investigating historical data reveal that is an oversimplification. For examples, historical databases for remission free survival of patient with AML indicates existence of single transition time beyond which hazard is changed. Similarly, investigation of time to cession of Zoster Associated Pain reveals a step hazard function. This clearly violates the underlying assumption of the design. An approximate likelihood function L(l1,l2,t) can be constructed by employing logistic transition function to smooth the hazard function. Function for sample size estimate will be provided and its utility will be examined through examples.

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