Clinical

FDA, Friends identify next steps for dose optimization, pragmatic trials, academic-led studies for drug approvals

FDA, Friends identify next steps for dose optimization, pragmatic trials, academic-led studies for drug approvals

To improve evidence generation in studies designed to bring therapeutic agents to market, FDA is urging drug sponsors not to skip dose optimization at the outset of clinical development. The agency is also telling industry that it’s open to accepting trials that have pragmatic elements and are augmented by data generated in academia.