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Abstract Details

Activity Number: 473
Type: Contributed
Date/Time: Wednesday, August 1, 2012 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #305938
Title: Estimation of Correlation Between Overall Survival and Surrogate Endpoints
Author(s): Fang Fang and Liping Huang*+ and Minghua Shan and Xiaosha Zhang
Companies: Bayer Healthcare Pharmaceuticals and Bayer Healthcare Pharmaceuticals and Bayer Healthcare Pharmaceuticals and Astellas Pharma U.S., Inc.
Address: 340 Changebridge Road, Montville, NJ, ,
Keywords: oncology ; overall survival ; progression free survival ; time to progression ; correlation
Abstract:

Overall survival (OS) is the gold standard for measuring clinical benefit in oncology trials. Surrogate measures of survival such as time to progression (TTP) and/or progression free survival (PFS) are clinically relevant endpoints and may be acceptable for drug approval. The correlation between TTP/PFS and OS has investigated by literature-based analysis of randomized trial in different cancer types, including colorectal, colon, breast and non-small cell lung cancer. The statistical models which describe the dependence structure between OS and TTP/PFS are almost non-existing. Observations on OS and TTP/PFS can be censored. We use both parametric approach and bootstrap method to perform the simulation to investigate the correlation between OS and TTP/PFS in the presence of censoring.


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