JSM 2004 - Toronto

Abstract #301810

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Activity Number: 119
Type: Contributed
Date/Time: Monday, August 9, 2004 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #301810
Title: Designing an Optimal Futility Analysis for an Equivalence Trial Using Simulation and Historical Data
Author(s): Jeff Maca*+
Companies: Novartis Pharmaceuticals
Address: One Health Plaza, East Hanover, NJ, 07869,
Keywords: futility analysis ; simulation ; equivalence ; clinical trial
Abstract:

When designing a clinical trial to study a novel medication or a new formulation of a registered medication, the sponsor might consider including a futility analysis to minimize the risks involved in the study. These include both the unnecessary health risk for patients using an ineffective drug, as well as the risk to the company of continuing to run a trial which will not be able to support the claim desired by the sponsor upon completion of the study. In this case study, the design of a futility analysis was further complicated by the study objective of showing equivalence, and the lack of any strong knowledge of the true nature of the true treatment effect. Other unknown parameters that were expected to affect the futility analysis were a projected high dropout rate and an unknown enrollment distribution. Through the use of historical data and resampling techniques, an estimate of the efficacy profile of the new treatment was developed, and then used to determine the optimal time, endpoint, and criteria used in performing the futility analysis.

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