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Abstract:
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Having appropriate statistical tools for making an informed and quantitative Go/No-Go decision at the end of the proof-of-concept (PoC) study is essential for clinical development of an experimental drug since the planning a late stage trial such as Phase III is costly and time consuming. A significant progress has been made in the development of Bayesian methods for Go/No-Go decision in clinical trials in recent years. In this talk, we explore modified approaches to the existing methodology that may fit better for special situations such as rare disease patients. One of the main drivers of this illustration would be the probability of technical success (PTS) that is, a probability of success in both PoC and Phase III trial, published by Michael Hay et. al. (2014). Additionally, we will discuss how to utilize graphical summary display of PTS for rare diseases.
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