Abstract #301607

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JSM 2003 Abstract #301607
Activity Number: 33
Type: Invited
Date/Time: Sunday, August 3, 2003 : 4:00 PM to 5:50 PM
Sponsor: ENAR
Abstract - #301607
Title: Measuring and Understanding Effect Size in Noninferiority Trials
Author(s): Ralph B. D'Agostino, Sr.*+
Companies: Boston University
Address: 111 Cummington St., Boston, MA, 02215-2411,
Keywords: noninferiority trials ; active control trials ; effect size ; treatment differences ; putative placebo
Abstract:

Due to the ethical issues in employing placebos in drugs, biologics and device trials, non-nferiority randomized active control trails have received substantial attention and are often suggested as the appropriate means of evaluating new treatments. With these studies a number of concerns have emerged. One major concern which often is clouded by discussions on non-inferiority margins, assay sensitivity and putative placebos is the issue of assessing treatment effects, both between the new treatment and active control and the new treatment and placebo. We discuss the assessment of treatment effect sizes--how they relate to the measures used for quantifying the noninferiority margins. Appropriate forms of treatment effects such as differences and ratios are reviewed. Also the role of meta-analysis is discussed. Examples from drug and device trials are used for illustration.

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