Abstract #301015

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JSM 2003 Abstract #301015
Activity Number: 349
Type: Invited
Date/Time: Wednesday, August 6, 2003 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #301015
Title: Type I Error Rate and Power Considerations in Assessing Treatment Efficacy Involving Correlated Multiple Endpoints
Author(s): Mohammad F. Huque*+ and George Y.H. Chi
Companies: Food and Drug Administration and Food and Drug Administration
Address: 4830 Sweetbirch Dr., Rockville, MD, 20853-1481,
Keywords: multiple endpoints ; Type I error ; power of the test
Abstract:

A clinical trial generally involves multiple correlated endpoints for the assessment of clinical efficacy and for the interpretation of the clinical benefit of a drug or biologic. These endpoints are tested according to a strategy dependent on the objective of the trial and clinical considerations of the disease and the treatment under study. In this regard, the choice of the appropriate endpoints, how many and how they will be used in a clinical decision-making process, is critical. However, different clinical decision-making criteria that involve multiple endpoints dictate the setting of the null hypothesis and the control of the family-wise Type I error rate differently, impacting the power and sample size requirements. This presentation will examine some such clinical efficacy criteria in terms of the Type I error rate control and power comparisons. It will include two examples: one from dermatology and one from arthritis area.

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Revised March 2003