Shoddy Preclinical Data Used in Clinical Trial Proposals

Applications for Phase 1 and 2 human studies in Germany frequently lack sufficient information about an intervention’s efficacy in animal experiments, according to a new study.  

By Kerry Grens | April 5, 2018

ISTOCK, FOTOGRAFIXXRecent applications for human clinical trials submitted to ethical review boards in Germany are sorely lacking in preclinical evidence from high-quality animal experiments on the proposed treatment. According to a study published today (April 5) in PLOS Biology, more than 95 percent of the preclinical work cited by 109 clinical trial proposals lacked the hallmarks of best practices, such as randomization or blinding.

“This is incredibly alarming,” Shai Silberberg, director of research quality at the National Institute of Neurological Disorders and Stroke in Bethesda, Maryland, tells Science. The study “shows that decision-makers for ethics related to clinical trials don’t get the information they really need to evaluate those preclinical trials.”

See “Preclinical Studies Don’t Regularly Adhere to Best Practices

Nevertheless, the studies were approved. The authors examined clinical trials submitted to and approved by institutional review boards at three German biomedical institutions between 2010 and 2016. These 109 proposals included 708 preclinical efficacy studies.

The research team found that the vast majority of the preclinical work—89 percent—was not published in a peer-reviewed journal. Furthermore, 82 percent reported only positive findings.

“With a median group size of 8 animals, these studies had limited ability to measure treatment effects precisely. Chance alone should have resulted in more studies being negative—the imbalance strongly suggests publication bias,” study coauthor Susanne Wieschowski, a postdoc at Hannover Medical School in Germany, says in a press release.

According to Science, Wieschowski and colleagues suspect the situation is similar in other countries.

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Avatar of: Leonid Schneider

Leonid Schneider

Posts: 10

April 7, 2018

It is so refreshing to read that Hannover Medical School (MHH) is so concerned about patient safety these days. It was not always the case. Their current adjunct professor Paolo Macchiarini is infamous for his trachea transplants, into which MHH was involved. Back in those days, preclinical animal tests were not deemed as importnant. Macchiarini's doctorate student Philipp Jungebluth received his MD degree from MHH, his thesis describing the first trachea transplant from 2008 (the graft was prepared by Jungebluth in a Bristol veterinary lab) was exempt from investigation by rector's decree just last year.
And then of course there was outsourcing of clinical tests of heart valves to Moldova.

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