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 - #308940
Title: Competing Risks Methods in Safety Analysis of Oncology Clinical Trials
Author(s): Sofia Paul+ and Bingqing Zhou*+ and Samit Hirawat and Glen Laird
Companies: Novartis Pharmaceuticals Corporation and The University of North Carolina at Chapel Hill and Novartis Pharma and Novartis Pharmaceuticals Corporation
Address: , East Hanover, NJ, 07936, , , ,
Keywords: survival ; competing risks ; cumulative incidence ; safety endpoint

Most widely used survival analysis methods can lead to biased estimates and tests in presence of competing causes of failure for an endpoint. For example, the Kaplan-Meier estimator has no survival function interpretation and its complement usually overestimates the true cumulative incidence (CI); the cumulative hazard in the Cox model has no direct clinical interpretation (Pepe & Mori, 1993). The counterparts of these methods for competing risk, the CI estimator (Gray, 1988) and proportional subdistribution hazards model (Fine & Gray, 1999), are more appropriate. Competing risks are observed in safety endpoints as well. In our example, it is time to first onset of a toxicity parameter. Discontinuation due to other reasons (e.g. death, progression of disease, other adverse events) was considered competing risks. Our goal is to determine the effect of covariates on toxicity incidence.

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