All Times EDT
Keywords: Bayesian, early phase, Go/no-go decision, Quantitative decision making
Traditionally, Go/No-Go decision for a Proof-of-Concept (PoC) trial is based on P values. Considering POC study or early drug development is usually not confirmatory that requires statistical significance testing, nowadays a quantitative decision making (QDM) is popularly used for informed decision making. A QDM can be formulated using frequentist or Bayesian framework. In this roundtable discussion session, multiple approaches and considerations, including choosing lower reference value and target value, setting the level of significance and relevance criteria, evaluating operating characteristics, handling interim analysis, dealing with count data and time to event data, will be discussed.