Abstract #300874

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JSM 2003 Abstract #300874
Activity Number: 470
Type: Contributed
Date/Time: Thursday, August 7, 2003 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section
Abstract - #300874
Title: Power and Sample Size Calculation for Clinical Trials with Recurrent Event Data
Author(s): Chin-Yu Lin*+ and Jen-Pei Liu and Sue-Jane Wang
Companies: National Health Research Institutes and National Cheng-Kung University and Food and Drug Administration
Address: Div. of Biostatistics & Bioinformatics, Taipei, , 11529, Taiwan
Keywords: power ; sample size ; recurrent event data
Abstract:

Many clinical trials involve the collection of data on the time to occurrence of the same type of event several times. Examples include tumor recurrences in cancer research, fertility histories for women and hospitalization of acute schizophrenia. Much of the literature addresses the issue of power and sample size needed when the interest lies in the time to the first event. The development of analysis methods for multivariate time-to-event data by Anderson and Gill (AG model, 1982), Wei, Lin and Weissfeld (WLW, 1989), etc., has prompted the need to also consider the power and sample size calculation for analysis of recurrent event data. We developed a SAS macro to estimate power of the AG model under a general model assumption. Sample size estimation formula under a more restricted setting will also be provided. In addition, simulation studies will be performed to investigate the sample size required for treatment effect comparison using recurrent event data and time-to-first-event data.

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