FDA Oncology shared a post on X:
“NEW: FDA releases draft guidance on overall survival assessment in oncology trials, with an emphasis on analyzing overall survival as a pre-specified safety endpoint.”
Bishal Gyawali, Associate Professor at Queen’s University and Associate Editor of the Journal of the National Cancer Institute, shared this post, adding:
“Emphasis on overall survival is good, but as a safety endpoint or as an efficacy endpoint? Safety implies we don’t want to see a worse OS. Efficacy implies we want to see improved OS.”
More posts featuring FDA Oncology and Bishal Gyawali.