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 last week’s issue of The Cancer Letter, Raja Flores wrote a guest editorial explaining how he, with his expertise in thoracic surgery, took issue with a nuance in a recent Keytruda commercial.
