Researchers examined trial documents from 78 randomized trials conducted between 1991 and 2011 for 17 antibiotics. These documents included study protocols, statistical analysis plans and informed consent forms submitted to the European Medicines Agency. The trials included 39,407 patients. The research team analyzed documents from 50 trails in the informed consent form analysis.
All informed consent forms contained sections describing study purpose. But, none consistently conveyed the hypothesis to both methodologists and patient investigators. Methodologists found one in 50 conveyed a study purpose, while patient investigators found 11 of 50 did the same.
“Patients were not accurately informed of study purpose, which raises questions regarding the ethics of informed consent in antibiotic trials,” study authors concluded.
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