ARTICLE | Regulation
Moving confirmatory trials to a learning system
Continuing biomarker studies after an accelerated approval would have clear benefits for patients, physicians and payers
September 1, 2021 1:01 PM UTC
As constructed, postmarket outcomes studies are aiming low. Though the goal is to confirm an efficacy signal that supports an accelerated approval, the trials could do so much more.
An ambitious view for accelerated approval sees the pathway employed in many diseases beyond its stronghold in cancer, with data from postmarket studies feeding back in real time to start building confidence in a drug’s clinical benefit faster than today, and to create a more comprehensive picture of the treatment effects, including which patients are most likely to benefit...