WITHDRAWN: Optimizing a Clinical Trial Within the Context of an Adaptive Clinical Drug Development Plan

• Activity Number: 377
• Type: Topic Contributed
• Date/Time: Tuesday, August 5, 2014 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Brenda Gaydos
• Companies: Eli Lilly and Company
• Keywords: clinical plan ; adaptive ; trial design ; decision criteria

Abstract

A clinical drug development plan evolves adaptively. The clinical plan consists of a series of trial designs and decision criteria, where the direction of future development and the design of future trial(s) depend on the outcome of the previous trials. For example, in order to optimize phase 2, the decision criteria that will form the basis of a go decision and how the estimates from phase 2 will impact the phase 3 plans need to be understood. The system of trials, including decision criteria, needs to be simulated as a system to appropriately account for correlation. We propose an approach to quantify the uncertainty of key clinical attributes throughout a molecules development. At the design stage of each trial, the uncertainty, decision criteria, and alternative clinical plans would be simulated prior to finalizing the design. Examples will be provided.