|
Abstract:
|
Recent years have seen a wave of innovation in the design and analysis of clinical trials for medical product development. These innovations have been spurred by increasing costs, increasing complexity of important scientific questions, significant increases in the number of products being developed for rare diseases, and growing dissatisfaction in the statistical and medical community with the experimental and inferential tools traditionally used in drug development. In this talk, I will review programs and actions taken by the U. S. Food and Drug Administration to promote and integrate innovative clinical trials in drug and biologic regulation. The topics discussed will include recent guidance on adaptive design clinical trials, the PDUFA VI pilot program for complex and innovative trial design feedback, increased use of Bayesian methods, and the ongoing development of best practices for clinical trial simulation.
|
