Abstract #301740

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JSM 2002 Abstract #301740
Activity Number: 396
Type: Topic Contributed
Date/Time: Thursday, August 15, 2002 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section*
Abstract - #301740
Title: Simulation for Power and Type I Error Computation in Complex Trials: Some Examples
Author(s): Keaven Anderson*+
Affiliation(s): Centocor, Inc.
Address: 200 Great Valley Pkwy, Malvern, Pennsylvania, 19355, USA
Keywords: simulation ; clinical trials ; trial design ; group sequential
Abstract:

The EPIC, CAPTURE, EPILOG, and EPISTENT trials were all cardiovascular trials testing the efficacy of abciximab in the setting of percutaneous coronary intervention. These trials all had one or more of the following design features that added some level of complexity to the evaluation of Type I error and power: multiple primary endpoints (related, but not identical), group sequential analysis with specialized spending functions, more than two treatment groups, and the use of the generalized logrank test. We will discuss the use of standard asymptotic approximations for initial estimates of trial properties and the subsequent refinement of designs using simulation. In order to use simulation adequately for this purpose, a large number of simulations were required, which, in turn, required the use of specialized programming.

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Revised March 2002