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Abstract:
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We investigate the effectiveness of a simple clinical development plan: POC followed by a phase 3 trial. This is done in the context of several possible go/no go criteria for the phase 2 trial, several design strategies for the phase 3 trial, under simulation settings ranging from no effect to a vigorous effect. Go/No Go criteria investigated include p-value based, Bayesian, and Assurance based. Design operating characteristics for phase 3 include power, assurance, as well as simple assuming a target value-based effect. These simulations provide insights into possible clinical development design choices..
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