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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER