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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