The Rise of Real-World Evidence in Regulatory Strategy, Part 4: RWE in Postmarketing Studies

In this fourth part of our series in collaboration with Analysis Group, Wayne chats with Dr. Marianne Cunnington, Managing Principal at Analysis Group, and Dr. Robert Reynolds, Vice President and Head of Development Sciences at GSK. Together, they discuss the evolution of postmarketing drug surveillance, the current scope of postmarketing studies, triggers for postmarketing commitments and requirements, safety and effectiveness questions best addressed after approval, studying populations excluded from clinical trials, standards for robust postmarketing evidence, real-world evidence in confirmatory studies, AI and automation in postmarketing research, transparency in study protocols and results, FDA monitoring and enforcement of postmarketing requirements, and much more.
This episode and the rest of our series do not include the usual Headlines segment.
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Music by Dvir Silver from Pixabay.