JSM 2004 Online Program

Abstract #300371

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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 - #300371
Title:	A Method to Estimate the Variance of an Endpoint from an Ongoing Blinded Trial
Author(s):	Jitendra Ganju*+ and Biao Xing
Companies:	Chiron Corporation and University of California, Berkeley
Address:	4560 Horton St., Emeryville, CA, 94608,
Keywords:	adaptive design ; interim analysis ; sample size re-estimation
Abstract:	We propose a new method for estimating the variance of an endpoint from an ongoing blinded trial. Our method makes no strict assumption on the density form of the data distribution. The proposed blinded variance estimator is unbiased and compares favorably, when the randomization block size is small, with its unblinded counterpart. We apply our method to data from two clinical trials to estimate the variance of an endpoint and compare it with the result obtained from an EM algorithm based approach.

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