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In this section we will explore the current state of the industry for adaptive designs. A focus will be on exploring applied trial designs.
In this talk a wide range of adaptive trial designs will be explored. These trial designs will be from a wide range of development stages as well as therapeutic areas. This will include innovative customized CRM trials for phase I, response adaptive dose-finding phase II trials, basket trials in phase II and phase III as well as adaptive trials for pivotal trials. A discussion of seamless trials will be presented as well.
Specific Discussion Topics will be: The role of Bayesian and frequentist aspects will be addressed. The role of simulation in adaptive trials Regulatory Interactions Operational Issues
Specific adaptive and modeling aspects Discussed will be Response Adaptive Randomization Enrichment Modeling Posterior/Predictive Distributions Longitudinal Modeling Dose-Response Modeling Stopping for success Stopping for futility Adaptively selecting sample size
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