Seminars

General Departmental Seminar Series

Carvedilol and the
Food and Drug Administration Approval Process

Ellen Roecker, Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison

Friday, November 19, 1999, 12:00-1:00 p.m.

E5/584 Clinical Science Center, 600 Highland Avenue

ABSTRACT

A recent issue of Controlled Clinical Trials (CCT, Feb 1999, 20:1-51) contained several articles discussing the FDA approval of carvedilol for treatment of congestive heart failure, from the perspective of two statisticians who participated in the process (Lloyd Fisher and Lem Moy). The data, approval process and issues raised were relatively unusual, with statistical arguments both for and against approval. Central to the discussion was the "two positive-trial FDA paradigm," as well as fundamental statistical considerations regarding hypothesis testing, control of type I error, and strength of evidence. In this seminar, I will describe the process and debate what occurred, as it is portrayed in the CCT articles and the public transcripts of the FDA Advisory Committee meetings. I will conclude with a brief overview of what has since been learned about beta-blocker treatment of congestive heart failure, in clinical trials that we have been involved with and elsewhere.

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