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.
In modern oncology, important insights from clinical trials often emerge years after initial publication. As new therapies extend survival and transition more patients into long-term remissions, clinicians and researchers are increasingly looking beyond initial response rates to understand durability, long-term safety, and even the possibility of a cure.
