A Framework for Joint Modeling and Joint Assessment of Efficacy and Safety Endpoints for Probability of Success Evaluation and Optimal Dose Selection
View Presentation Xiting Cao, University of Minnesota *Weili He, Merck & Co., Inc. Lu Xu, Sanofi-Aventis Keywords: joint modeling, joint evaluation, Bayesian method, probability of success, MCMC, clinical utility index The evaluation of clinical proof of concept, optimal dose selection, and phase III probability of success (POS) has traditionally been conducted by a subjective and qualitative assessment of the efficacy and safety data. This in part was responsible for the numerous failed phase III programs in the past. The need to utilize more quantitative approaches to assess efficacy and safety profiles has never been greater. We propose a framework that incorporates efficacy and safety data simultaneously for the joint evaluation of clinical proof of concept, optimal dose selection, and phase III POS. The proposed approach was applied to two real clinical studies. On the basis of the true outcome of the two clinical studies, the assessment based on our proposed approach suggested a reasonable path forward for both clinical programs.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC