Antibiotic Clinical Trials Are Not Properly Informing Human Test Subjects Of Risks: Study

Researchers indicate that consent forms commonly used for drug studies involving antibiotics typically do not tell participants enough information about the goals of the trial, according to a new study. 

A report published last week in the medical journal JAMA Internal Medicine raises questions about whether patients participating in antibiotic drug trials are able to truly give informed consent, given the incomplete information they are provided about the potential risks.

Researchers from the University of Maryland School of Pharmacy found that the studies failed to adequately detail what the purpose and goals of those studies were.

The study looked at a cross-sectional analysis of study protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) from 78 randomized clinical trials submitted to the European Medicines Agency from 1991 to 2011 involving antibiotics.

According to the findings, these studies involved 17 different antibiotics and enrolled a total of 39,407 patients. However, many of the documents given to patients detailing the purpose and hypotheses of those studies were lacking in details. The researchers did an informed consent form analysis in 50 of the studies.

“All ICFs contained sections describing study purpose; however, none consistently conveyed study hypothesis to both methodologists and patient investigators,” the researchers noted. “Patients were not accurately informed of study purpose, which raises questions regarding the ethics of informed consent in antibiotic trials.”

Researchers are constantly looking for ways to make existing antibiotics more effective as more and more pathogens become resistant to many forms of treatment.

Antibiotic-resistant bacteria has risen to the forefront of public concern in recent years as more drug resistant superbugs emerge. A study published last year revealed patients put in a bed last used by another patient who was treated with antibiotics are 22 percent more likely to get a hospital-acquired infection. Another recent report warned that 1 in 7 hospital infections are now antibiotic resistant.

Despite continued warnings of the emergence of antibiotic-resistant bacteria hospitals continue to overuse antibiotics. Antibiotic-resistant infections cause more than 23,000 deaths each year.

The risk of death from antibiotic-resistant bacteria is two to three times greater than from other bacteria. A report from 2014 indicated deaths from superbugs would reach more than 10 million each year by the year 2050.