Abstract #300797

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JSM 2003 Abstract #300797
Activity Number: 31
Type: Contributed
Date/Time: Sunday, August 3, 2003 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300797
Title: Sample Size and Power Analysis for Endometrial Safety Studies
Author(s): Guoqin Su*+
Companies:
Address: 61 Stratford Cir., Edison, NJ, 08820-1804,
Keywords: endometrial safety study ; binomial parameter ; Poisson parameter
Abstract:

Endometrial safety studies are required for approval of progestin components. The CPMP requirement is the actual percentage below 2% and the upper limit of 1-sided exact 95% confidence interval not more than 2% above the point estimate. The recent FDA requirement is the actual percentage below 1% and sample size and power to satisfy both requirements based on exact confidence intervals for the binomial parameter and the Poisson parameter. It is shown that larger sample size does not always lead to higher power. An optimal sample size for satisfying both requirements is presented, and it is recommended that patient enrollment should be closely monitored during the study.

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