Abstract #300982

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JSM 2003 Abstract #300982
Activity Number: 247
Type: Contributed
Date/Time: Tuesday, August 5, 2003 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #300982
Title: Alternative Strategies for Managing Multiple Endpoints in the Noninferior/Equivalence Assessment of a Test Vaccine Relative to a Standard Vaccine
Author(s): Lan Kong*+ and Robert C. Kohberger and Gary G. Koch
Companies: University of North Carolina and Wyeth-Lederle Vaccines and University of North Carolina, Chapel Hill
Address: 1411 Southpoint Crossing Dr., Durham, NC, 27713-6609,
Keywords: equivalence ; multiple endpoints ; noninferiority ; power ; Type I error ; vaccine
Abstract:

Clinical trials necessary for the development of new vaccines often require testing of multiple endpoints for equivalence or noninferiority. An example is a study with multiple antibody measurements in sera of subjects receiving a combination vaccine such as a pneumococcal vaccine which contains many different serotypes of the pneumococcal organism. This paper describes testing methods for the demonstration of uniform equivalence or noninferiority of two treatments on each component of the response vector that follows a multivariate normal distribution. Systematic simulation studies are conducted to evaluate the performance of the testing methods and to examine under what conditions the power loss is excessive if the multiple endpoints are assumed to be independent when they are actually not. Data from an illustrative example are used to describe how the study power can be evaluated in the design of the trials.

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