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The use of model based adaptive dose response in choosing doses in a lean clinical development plan
If you have a question about this talk, please contact Peter Watson.
Dose finding is a pivotal part of drug development, however, many dose finding experiments are still inefficient leading to a poor choice of dose in Phase III . This is leading to attrition in Phase III . Knowledge of dose response relationships is important in establishing safe and effective drugs, with ICH E4 stating – “The purpose of Dose Response is to have knowledge of the relationships among dose, drug concentration and clinical response”. One thing that we should always ask is “How do you know that lower doses are just as effective and safe?” Information of the dose response relationship can be gathered in pre-clinical experiments and early phase clinical trials, however, this information is rarely used. If we can assume the shape of the dose response is similar moving through the phase it may be possible to derive a leaner paradigm of drug development. In this presentation I will give an illustration of the use of adaptive, optimal design and Bayesian methods in a lean drug development paradigm. It will explore techniques, whilst not new, are not as readily used as they should be. The illustration will use a typical immunology compound, however, the principles can be applied to many therapeutic areas.
This talk is part of the Cambridge Statistics Discussion Group (CSDG) series.
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