Abstract #300497

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JSM 2003 Abstract #300497
Activity Number: 135
Type: Luncheons
Date/Time: Monday, August 4, 2003 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300497
Title: Regulatory, Ethical, and Statistical Issues of the FDA's Accelerated Approval Process - THIS LUNCHEON IS SOLD OUT
Author(s): Qing Liu*+
Companies: RWJ Pharmaceutical Research Institute
Address: PO Box 300, Raritan, NJ, 08869-0602,
Keywords:
Abstract:

Under the Clinton administration, the FDA initiated an accelerated approve process under 21 CFR 314.510. We will discuss 1) current trend in granting accelerated approval reviews by the FDA, and possible new political realities after appointment of McClellan by the Bush administration; 2) issues of current implementation, including the trial design, selection of surrogate endpoints, need to control the Type I error rates of the surrogate and survival endpoint, impact of switching to new drugs after the initial approval on survival analysis, and bias in the final analysis, etc.; and 3) roles of multistage adaptive designs.

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Revised March 2003