Re­searchers call for us­ing more than sur­ro­gate out­comes to ap­prove new an­tibi­otics

Many re­cent an­tibi­ot­ic ap­provals from the FDA are based on few­er, small­er and less rig­or­ous piv­otal tri­als, which rais­es fresh ques­tions about what new in­cen­tive pro­grams might do for the an­tibi­otics in­dus­try, re­searchers from Har­vard Med­ical School and George Wash­ing­ton Uni­ver­si­ty School of Med­i­cine wrote in the BMJ this week.

The find­ings high­light the need for not on­ly new an­tibi­otics, but al­so ones that show clin­i­cal­ly rel­e­vant ev­i­dence of ef­fec­tive­ness and added ben­e­fits for the pa­tient, they wrote.

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