This year’s forum addressed statistical innovation developments (e.g., complex innovative designs, complex generic products) with an emphasis on real world data, real world evidence, master protocols and causal inference. Rare diseases, safety, patient-focused drug development, and cancer patient journeys and estimands were other topics.
Dr. Janet Woodcock described the reorganization plan for CDER’s Office of New Drugs. Notably, NDA and BLA reviews will be issue-based. She also describe the effect of the reorganization on the statistical community and opportunities for statistical advancements.