Legend: Palais des congrès de Montréal = CC, Le Westin Montréal = W, Intercontinental Montréal = I
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
A * preceding a session name means that the session is an applied session.
A ! preceding a session name means that the session reflects the JSM meeting theme.
Activity Details
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| CE_02C | Sat, 8/3/2013, 8:30 AM - 5:00 PM | W-Ville-Marie | |
| 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. | |||
2013 JSM Online Program Home
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If you have questions about the Continuing Education program, please contact the Education Department.
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