When conducting a randomized clinical trial of a treatment regimen based on an immune checkpoint inhibitor, trial sponsors should include overall survival as an endpoint, FDA officials say.
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.
