Keywords: probability of success, Go-NoGo
Drug discovery is an expensive, slow and complex process. Through the process, quantitative decision making occurs at all stages of drug development to stop the program, conduct additional clinical trials, or move on to next phase of development. Based on data from Clinical Development Success Rates 2006–2015 by BIO, BioMedTracker and Amplion, the overall rate of approval from Phase I for all developmental candidates was only 9.6%. Therefore, improving the success rate and making correct decisions of “success or failure” at different stages is critical to save the cost and the time to get a drug to market. The purposes of the roundtable are to provide an opportunity for stakeholders to share experiences (no matter good and bad), identify gaps and opportunities, learn current state of knowledge and practice, and discuss approaches and principles in using quantitative methods and modeling to aid drug development.
Potential questions for discussion: 1. Share experiences how you were involved in the critical decision in drug development 2. What process do you follow in decision making at different stage of the drug development? 3. What is the most critical step in the decision making procedure? 4. What statistical methodologies do you use to quantify the probability of success (PoS)? 5. Do you have any rules of thumb when applying the PoS in Go-NoGo decision making? 6. Anything we can do better to improve the estimation of success rate?