Abstract #300714

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JSM 2003 Abstract #300714
Activity Number: 176
Type: Contributed
Date/Time: Monday, August 4, 2003 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300714
Title: Properties of a Procedure to Estimate Treatment Difference and Standard Deviation with Blinded Data
Author(s): Farid Kianifard*+ and Michael Chen
Companies: Novartis Pharmaceuticals and Novartis Pharmaceuticals
Address: Biometrics, East Hanover, NJ, 07936-1016,
Keywords: drug development ; folded normal distribution ; sample size re-estimation
Abstract:

In drug development, one often uses the estimated treatment difference and standard deviation of a normally-distributed response variable from previous clinical trials to determine the sample size needed for future trials. Chen and Kianifard (2003) introduced a procedure, based on the properties of the folded normal distribution, to allow the estimation of these two parameters before the ongoing trial is completed, thereby shortening drug development time. By preserving the blind, potentially biased conduct of the trial in favor of the patients in one of the two treatment groups will be prevented. One may decide to abandon plans for future trials if the estimated treatment difference is much smaller than the minimal clinically meaningful treatment difference, or choose to reduce the sample size for future trials if the estimated treatment difference is much larger than expected. We evaluate the Type I error, power, and the expected sample size when this procedure is used to re-estimate the sample size for an ongoing clinical study.

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