Re­searchers call for fi­nan­cial in­cen­tives to speed con­fir­ma­to­ry tri­als for ac­cel­er­at­ed ap­provals

Bio­phar­ma com­pa­nies that win new ac­cel­er­at­ed ap­provals typ­i­cal­ly have no fi­nan­cial in­cen­tive to com­plete their con­fir­ma­to­ry tri­al be­cause the price of the treat­ment doesn’t change once an ac­cel­er­at­ed ap­proval con­verts to a full ap­proval, re­searchers from Har­vard, the Uni­ver­si­ty of Penn­syl­va­nia and the Brook­ings In­sti­tu­tion wrote in a new Health Af­fairs study pub­lished yes­ter­day.

Even as new can­cer drugs ap­proved un­der the AA path­way are launched at prices in ex­cess of $100,000, com­pa­nies of­ten gain lit­tle from com­plet­ing a quick con­fir­ma­to­ry tri­al, and at least part of the prob­lem, the re­searchers say, is that the FDA rarely with­draws a drug from the mar­ket be­cause a com­pa­ny has failed to con­duct a con­fir­ma­to­ry tri­al or be­cause the con­fir­ma­to­ry tri­al showed no ben­e­fit.

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