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An adaptive optimal design for the Emax model and its application in clinical trials

Leonov, S (GlaxoSmithKline)
Thursday 14 August 2008, 16:00-16:30

Seminar Room 1, Newton Institute


We discuss an adaptive design for a first-time-in-human dose-escalation study in patients. A project team working on a compound wished to maximize the efficiency of the study by using doses targeted at maximizing information about the dose-response relationship within certain safety constraints. We have developed an adaptive optimal design tool to recommend doses when the response follows an Emax model, with functionality for pre-trial simulation and in-stream analysis. We describe the methodology based on model-based optimal design techniques and present the results of simulations to investigate the operating characteristics of the applied algorithm.




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