In this Clinical Trials Demystified series, session 3 talk, meet Dr. Carmen Allegra from the NCI, Dr. Jennifer Wright from Lilly and Dr. Chana Weinstock from the FDA talk about drug development and approval and discusses many relevant issues with Paltown Scientific Director, Dr. Manju George. A transcript is available on CTU
Summary:
The session, led by Dr. Manju George, explored the collaboration between the FDA, industry, and NCTN in cancer drug development. Dr. Carmen Allegra detailed the evolution and structure of NCTN, highlighting its centralized operations and global participation. Dr. Jennifer Wright explained pharma-led trials, emphasizing early-phase studies and the challenges of enrollment and control arms. Dr. Chana Weinstock from the FDA discussed the approval process, expedited programs, and the role of real-world data. Key points included the importance of patient representation, the role of clinical trials in providing optimal care, and the need for transparency in trial results and adverse events.
