More than half of ac­cel­er­at­ed ap­proval con­fir­ma­to­ry tri­als are late, re­searchers write in JA­MA

The ma­jor­i­ty of con­fir­ma­to­ry tri­als for ac­cel­er­at­ed ap­provals — meant to de­fin­i­tive­ly show clin­i­cal ben­e­fit fol­low­ing use of a sur­ro­gate for the ini­tial AA — are late and de­layed be­yond when the FDA has re­quest­ed they fin­ish, Har­vard and Geor­gia State Uni­ver­si­ty law and med­ical pro­fes­sors wrote in a re­search let­ter in JA­MA Health Fo­rum on Fri­day.

Har­vard’s Aaron Kessel­heim and Ben Rome, as well as Geor­gia State law pro­fes­sor An­jali Desh­mukh, took a look at 177 con­fir­ma­to­ry tri­al re­quire­ments, not­ing that the me­di­an time al­lowed to com­plete these tri­als was three and a half years post-ap­proval from Jan­u­ary 2012 in­to the fall of 2021.

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