Deak D, Powers JH, Outterson K, Kesselheim AS - Annals of Internal Medicine
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Summary:
The authors acknowledge that noninferiority trial designs for new antibiotics can benefit patients but emphasize their important limitations: such trials are conducted in patients with effective therapeutic options and do not directly address whether an investigational product is effective against resistant pathogens—and when antibiotics approved via noninferiority trials are used in patients with resistant disease, they may actually show worse clinical outcomes.
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