Abstract #301138

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JSM 2003 Abstract #301138
Activity Number: 130
Type: Contributed
Date/Time: Monday, August 4, 2003 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #301138
Title: Data Transformation when Testing for Noninferiority or Equivalence Hypotheses
Author(s): Yi Tsong*+ and Juan (Joanne) Zhang
Companies: Food and Drug Administration and Food and Drug Administration
Address: CDER, 13215 Lazy Glen Lane, Herndon, VA, 20171,
Keywords: active control ; noninferiority ; data transformation
Abstract:

In an active controlled clinical trial, the noninferiority or equivalence margin is often derived from historical data from placebo controlled clinical trials for efficacy of the active reference treatment under the normal assumption. However, it is not unusual that the data collected in the current trial do not follow the normal distribution. In such a situation, the study needs to be analyzed with transformed data or using a nonparametric test. Accordingly, the noninferiority or equivalence margin must be redefined in the statement of the hypotheses. We will present some of the considerations involved with data transformation.

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