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Improving dose-finding methods in clinical development: design, adaptation, and modeling

Pinheiro, J (Johnson & Johnson)
Tuesday 16 August 2011, 12:00-12:30

Seminar Room 1, Newton Institute


The pharmaceutical industry experiences increasingly challenging conditions, with a combination of escalating development costs, tougher regulatory environment, expiring patents on important drugs, and fewer promising drugs in late stage of development. Part of this pipeline problem is attributed to poor dose selection for confirmatory trials leading to high attrition rates (estimated at 50%) for Phase 3 programs. Improving the efficiency of drug development, in general, and of dose-finding studies in particular, is critical for the survival of the industry. A variety of methods have been proposed to improve dose selection and, more broadly, understanding of the dose-response relationship for a compound. Among them: adaptive designs, modeling and simulation approaches, optimal designs, and clinical utility indices. In this talk we’ll discuss and illustrate the utilization of some of those approaches in the context of dose-finding trials. The results of a comprehensive se t of simulation studies conducted by the PhRMA working group on Adaptive Dose-Ranging Studies will be used to discuss the relative merits of the various approaches and to motivate recommendations on their use in practice.


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