JSM 2005 - Toronto

Abstract #302337

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 120
Type: Invited
Date/Time: Monday, August 8, 2005 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #302337
Title: What Would Fisher or Neyman Say?
Author(s): David Salsburg*+
Companies: Statistical Consultant
Address: 22 Holly Terrace, New London, CT, 06320,
Keywords: p-values ; drug research ; significance tests
Abstract:

There are three consumers of the statistical analyses in the drug approval process: the company sending in the NDA, the FDA reviewers, and the public of medical doctors who will use the new drug based on the material in the package insert. The company assembling an NDA would be best served if they viewed p-values as R.A. Fisher did. The FDA reviewers are most like the user Neyman had in mind. The medical public? This presentation will review different attitudes toward p-values and whether those attitudes are appropriate for a given audience.

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Revised March 2005