Key PointsQuestionHow often is the study purpose explained to potential participants in randomized clinical trials of antibiotics? FindingsIn this cross-sectional analysis of trial documents submitted to regulators, no informed consent forms consistently conveyed the primary hypothesis of the study. MeaningPatients enrolling in antibiotic clinical trials are not accurately informed of study purpose, raising fundamental questions of the ethics of consent in antibiotic drug trials.
JAMA Internal Medicine – American Medical Association
Published: Oct 21, 2017