Accelerated approvals under fire again as pivotal trials typically take about as long as confirmatory trials, research shows

One of the major reasons the FDA’s accelerated approval pathway receives so many accolades and so much support is that it speeds new and hopefully improved drugs to patients, usually in oncology, while confirmatory evidence on the clinical benefit can be gathered.

But a new research letter published Tuesday in JAMA Network Open raises fresh questions about the pathway, making the case that because the difference in the amount of time it takes to run the confirmatory trial vs. the pivotal trial is typically similar, the companies might as well run the equivalent of the confirmatory trial first.