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Abstract:
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Many drug development programs currently include a "Proof of Concept Study" (i.e., a Phase IIa study on which pharmaceutical management bases a decision whether to continue clinical development). Following up on last November's FDA/PhRMA workshop on "good proof of concept studies," participants in this luncheon roundtable will discuss the exploratory versus confirmatory nature of PoC studies, hypothesis testing versus estimation or hypothesis generation, research hypotheses as Go/No Go criteria for continuing clinical development, sizing (powering) PoC studies, use of Bayesian methods, and use of "enriched" populations.
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