Research Finds Drugs with Accelerated Approval Don’t Hold Up

from tHEORetically Speaking: The HealthEconomics.Com Blog at on May 31, 2019 at 04:02PM

New research by a team at Harvard Medical School’s Program on Regulation, Therapeutics and Law suggests that drugs with accelerated approval status generally fail to show clear benefits after follow-up trials, NPR reports.

Researchers took a deep dive into a 2018 study by the Food and Drug Administration on 93 cancer drugs which had received accelerated approval status over the course of 25 years. They found that only 19 of the 93 drugs “had improvement in overall survival.”

“Few cancer drugs approved via the accelerated FDA approval pathway were judged to have verified benefits based on improvement in survival reported in confirmatory trials,” the researchers state.

To read more on NPR, click here.

Click here to read the study on JAMA.