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.
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.
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