Patients enrolling in many clinical trials of antibiotics are not accurately informed of the trial purpose, which raises a question of ethics, according to a study published in JAMA Internal Medicine.

Because antibiotic trials frequently use noninferiority hypotheses, they need appropriate consent forms. The study report supplies 2 examples of suitable language for such forms. The need for this type of consent arose from the researchers’ study of 50 randomized antibiotic trials conducted within an 11-year period.

All trials had a section in their informed consent form describing the study purpose. None, however, consistently conveyed the study hypothesis to both methodologists and patient investigators.

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It was not explained to patients that a 10% inferiority of effect is allowed when a new antibiotic is compared with an older, effective drug because there may be fewer adverse events with the newer drug, making it an acceptable trade-off.

The authors concluded that noninferiority and superiority trials entail different benefit-harm trade-offs that must be conveyed for ethical informed consent.

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Doshi P, Hur P, Jones M, et al. Informed consent to study purpose in randomized clinical trials of antibiotics, 1991 through 2011. [published online August 21, 2017]. JAMA Intern Med. doi: 10.1001/jamainternmed.2017.3820