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Abstract:
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Decision making is a central part of drug development and a key driver of probability of success. Considerations relate to risk awareness and tolerance, and the quantifying and interpretation of pre-existing as well as generated evidence. Decisions like futility, GNG, or planned adaptation or early acceleration of a program have significant implications and as a result, the quality of the underlying decision-making process deserves careful consideration. P-value based decision making is becoming increasingly (appropriately) viewed as suboptimal, giving statisticians an opportunity to drive more suitable and conceptually meaningful methods to quantify evidence and support a decision-making framework. This talk will discuss various aspects of the target product profile (TPP) and its subsequent connection to both evidence generation and decision making. Comparison to traditional hypothesis testing-based strategies and associated operating characteristics will be provided.
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