JSM 2005 - Toronto

Abstract #303262

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Activity Number: 90
Type: Topic Contributed
Date/Time: Monday, August 8, 2005 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #303262
Title: Indirect Age Adjustment for Pregnancy Rates in Clinical Studies of Contraceptive Devices
Author(s): Yihua Zhao*+ and Gene Pennello
Companies: U.S. Food and Drug Administration and U.S. Food and Drug Administration
Address: 1350 Piccard Drive, HFZ-550, Rockville, MD, 20850, United States
Keywords: Bayesian Method ; Exact Frequentist Method ; Indirect Standardization
Abstract:

The U.S. Collaborative Review of Sterilization (CREST) study showed the cumulative risk of pregnancy after tubal sterilization was higher for younger women. Therefore, it makes sense to calculate an age-adjusted pregnancy rate for contraceptive devices under study, either for direct comparisons to a reference population (like the CREST population) or for determination of a theoretical rate in future patients should the age distribution among that group match identically to that observed in the reference population. Indirect age adjustment is usually used and requires observation of one or more pregnancies in each age group to be valid. When zero pregnancies are observed in all age groups in the study population, the standard statistical methods fail to produce valid estimates. In this talk, we will explain how to use the exact frequentist method and the Bayesian method to compute the 95% upper limit of the pregnancy rate when no pregnancies are observed in the study population. We also will compare the results obtained using the exact frequentist method and the Bayesian method and discuss the advantages and disadvantages of each.

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Revised March 2005