Abstract:
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In this presentation, I will discuss my experience and present a case study that outlines the steps that were taken to achieve regulatory approval under a Special Protocol Assessment for a Phase II/III adaptive study with dose selection after an interim analysis. Topics discussed will include criteria for dose selection, statistical methods for the interim and final analyses, and statistical software used for simulations of the design. The evolution of discussions with the FDA after each review will also be discussed, along with lessons learned.
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