JSM 2005 - Toronto

Abstract #304058

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 192
Type: Contributed
Date/Time: Monday, August 8, 2005 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #304058
Title: Issues in Mega Clinical Trials
Author(s): Lu Cui*+
Companies: Sanofi Aventis Pharmaceuticals
Address: 200 Crossing Blvd, Bridgewater, NJ, 08807, United States
Keywords: mega clinical trial ; treatment effect ; bias
Abstract:

Very large-scale or mega clinical trials have been seen more frequently due to the need of demonstration of relatively small treatment effects of the drugs and the global harmonization of drug development programs. Although mega clinical trials have the obvious advantage in statistical power, they have their own issues and potential drawbacks that should be aware of by clinical trial practitioners. In this presentation, several issues related to mega clinical trials are discussed from the trial design, operation, and submission point of views. The issues to be covered include biases and bias control in mega clinical trials, design modification, trial monitoring, interim analysis, decision policy, and submission strategy. Examples will be presented to illustrate the problems.

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Revised March 2005