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.
The first large cancer screening/early detection initiative to be launched in 2025—the NCI-funded Vanguard study of multi-cancer detection tests—has started accruing patients through nine sites across the U.S.
