All Times EDT
Keywords: Portfolio management, probability of success, Go/No-Go decision making
In clinical drug development, the researchers design confirmatory clinical trials aiming to show statistical significance in primary endpoints based on signals observed in early phase trials. However, these early promising results are not always translated into large-scale trials due to possible variations in endpoint, population or sometimes simply randomness. One of the metrics to quantify such uncertainty in clinical development is the Probability of Success (PoS). Under the Bayesian framework, one may make informed decision after accounting for prior knowledge such as clinical experts’ opinion, real-world data, early phase clinical data, etc. In a real world, the Go/No-Go decision making for a compound may also depends on other factors, e.g., potential market size, competitive landscaping of a certain disease area in industry or the pipeline situation within the company. During this round table, the following will be discussed: 1. How to determine the prior for PoS? 2. What type of external data shall be utilized? 3. What are the practical challenges in implementing PoS strategy? 4. What important factors should be considered when evaluating a compound’s potential? 5. Practical experience sharing