JSM 2012 Online Program

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CE_23C	Tue, 7/31/2012, 8:30 AM - 5:00 PM	HQ-Indigo 204
Design and Analysis of Noninferiority Trials — Continuing Education Course
ASA , Biopharmaceutical Section
Instructor(s): Brian Wiens, Alcon Laboratories
This one-day short course will review the basics of non-inferiority clinical trials and provide discussion on advanced aspects. Participants are expected to have some (at least minimal) experience with clinical trials aimed at regulatory approval for drugs, biologics or medical devices. The first half of the course will discuss background, assumptions, analyses and intended uses of non-inferiority trials, with focus on regulatory review of new medical products. Methods for choosing a sample size and for assuring validity and assay sensitivity will be discussed. The second half will include analysis methods for continuous data, binary data (including matched pair designs) and time-to-event data, and issues with non-inferiority trials, including multiple comparisons, missing data and adaptive designs. Throughout the course, examples will be presented to illustrate the concepts.

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