Animal studies regulators and ethicists use to determine whether an experimental drug should be tested in humans often contain poor quality data, according to a study published in PLOS Biology.
The researchers examined "investigator brochures," which regulatory agencies use to evaluate the risks and benefits of experimental treatments and determine whether trials should move from animals to humans.
"The way the animal studies are currently reported in the investigator brochures really strongly compromises this risk-benefit assessment," researcher Daniel Strech, PhD, bioethicist and professor at Hannover Medical School in Germany, told Reuters. "It's hard to see how people can really do meaningful risk-benefit assessments based on the animal studies the way they are reported."
The research team looked at 109 IBs approved by three German institutional review boards from 2010-16, which cited 708 animal studies. The majority of the studies had no more than eight animals. Less than 5 percent of the studies reported randomization, sample size outcome or blinded assessment and only 11 percent of the studies referenced published, peer-reviewed reports of preclinical efficacy.
Although the study was not able to say why investigators submit such poor quality data as well as why reviewers accept this data, "the feeling I got was that ethics committees and agencies don't really look at the preclinical efficacy data," Dr. Strech said.
Rather, regulators put their efforts toward the data about a drug's toxicity and safety, Dr. Strech added. "They more or less trust that the funders of the clinical trial, the industry and the investigators, that they would never do a clinical study unless they were very convinced that the drug would be effective."
That being said, one of the 25 largest pharmaceutical companies funded nearly half of the studies included in the analysis, Dr. Strech noted. A number of the studies included research teams from outside Germany, so this could be a global issue, he added.
"I would argue that the burden of proof is rather on those that would say that the picture is completely different in the United States or the U.K. or elsewhere," Dr. Strech said.