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Abstract:
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As part of its Pharmaceutical Innovation initiative, the Pharmaceutical Research and Manufactures of America (PhRMA) formed a working group on adaptive dose ranging studies (ADRS) to explore the value of this innovative class of designs in improving dose selection in drug development. The ADRS WG undertook an extensive simulation study comparing adaptive and non-adaptive dose finding methods, putting forward preliminary conclusions and recommendations on the use of these methods in drug development. This talk will present an update on the activities of the WG, based on a second round of simulation-driven evaluations, focusing on additional adaptive DR methods, use of exposure-response models in dose finding, and the impact of dose selection in Phase II on the probability of success in Phase III. Updated conclusions and recommendations from the WG will be presented.
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