Episode 100: Synthetic Control Arms and the Regulatory Maze

Vivek Subbiah, MD, executive director of medical oncology research, MD Anderson Cancer Network, makes his triumphant return to the show to break down designing clinical trials for investigative therapies and the regulatory maze that follows before these therapies can find their way to the market. Dr. Subbiah begins by using precision medicine advances in lung cancer as a backdrop for the discussion on histology agnostic drug approvals. Then, he moves into the full regulatory flow map of how drugs make their way from phase I trials through FDA approval. The accelerated approval pathway, post-approval trials, synthetic control arms, off-label data, real-world data, and assessment bias are all discussion points given ample attention in this truly informative interview.Check out Chadi’s website for all Healthcare Unfiltered episodes and other content. www.chadinabhan.com/Watch all Healthcare Unfiltered episodes on Youtube. www.youtube.com/channel/UCjiJPTpIJdIiukcq0UaMFsA