Abstract #300918

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JSM 2003 Abstract #300918
Activity Number: 135
Type: Luncheons
Date/Time: Monday, August 4, 2003 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300918
Title: Noninferiority Active Control Trial - THIS LUNCHEON IS SOLD OUT
Author(s): Hsien-Ming James Hung*+
Companies: Food and Drug Administration
Address: 9104 Orchard Brook Dr., Potomac, MD, 20854-2401,
Keywords: active control ; noninferiority margin ; statistical error
Abstract:

This discussion will focus on some key issues in noninferiority design and analysis: estimations of the effect of the active control from historical information, selection of noninferiority margin, and statistical error relevant to noninferiority analyses. Each topic gets equal time, depending on the flow of the discussion. The main objective is to exchange the perspectives between industry, academia, and the regulatory agencies.

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Revised March 2003