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Abstract:
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The cost for bringing a potential treatment from discovery to market has nearly doubled in the last 10 years and has now reached an astronomical amount of $2.5 billion. There is an urgent need to make drug development faster and less costly. Innovative trial designs/analyses, such those that leverage Bayesian approaches, as laid out in the FDA's Critical Path Initiative list is essential to meet this need. Bayesian research and applications in drug development has gained popularity in the last few years and Bayesian trial designs have shared a few successes in the early phase and in areas such as pediatrics and rare disease. However, its application in confirmatory trials has been challenging due to the perceived lack of regulatory acceptance as well lack of regulatory guidance. Recent policies such as the 21st Century Cures Act and PDUFA VI have the potential to dramatically change the landscape for acceptance of Bayesian methods in drug approval. This roundtable will bring in statisticians working in the drug development to discuss the current policies and landscape for Bayesian methods in drug approval.
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