Scott Gottlieb: I had the opportunity to discuss the accelerated approval of cancer drugs on CNBC and share insights from a recent JAMA study
Scott Gottlieb, Partner at New Enterprise Associates, shared on LinkedIn:
“Today, I had the opportunity to discuss the accelerated approval of cancer drugs on CNBC and share insights from a recent JAMA study. The FDA is applying greater vigilance toward confirmatory studies, and companies are dedicating more resources to fulfilling them. However, conducting randomized, placebo trials post-approval in settings of fatal disorders can be challenging. Patients with life-threatening conditions want access to beneficial options without the risk of being randomized to placebo. The FDA can giver greater consideration to practical studies and innovative trial approaches to gather rigorous evidence while ensuring that trial designs are feasible to enroll and run to completion.”
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Source: Scott Gottlieb/LinkedIn