Menu

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.  

Apr 5, 2018
Kerry Grens

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.

February 2019

Big Storms Brewing

Can forests weather more major hurricanes?

Marketplace

Sponsored Product Updates

Bio-Rad Releases First FDA-Cleared Digital PCR System and Test for Monitoring Chronic Myeloid Leukemia Treatment Response
Bio-Rad Releases First FDA-Cleared Digital PCR System and Test for Monitoring Chronic Myeloid Leukemia Treatment Response
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that its QXDx AutoDG ddPCR System, which uses Bio-Rad’s Droplet Digital PCR technology, and the QXDx BCR-ABL %IS Kit are the industry’s first digital PCR products to receive U.S. Food and Drug Administration (FDA) clearance. Used together, Bio-Rad’s system and kit can precisely and reproducibly monitor molecular response to treatment in patients with chronic myeloid leukemia (CML).
Bio-Rad Showcases New Automation Features of its ZE5 Cell Analyzer at SLAS 2019
Bio-Rad Showcases New Automation Features of its ZE5 Cell Analyzer at SLAS 2019
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) today showcases new automation features of its ZE5 Cell Analyzer during the Society for Laboratory Automation and Screening 2019 International Conference and Exhibition (SLAS) in Washington, D.C., February 2–6. These capabilities enable the ZE5 to be used for high-throughput flow cytometry in biomarker discovery and phenotypic screening.
Andrew Alliance and Sartorius Collaborate to Provide Software-Connected Pipettes for Life Science Research
Andrew Alliance and Sartorius Collaborate to Provide Software-Connected Pipettes for Life Science Research
Researchers to benefit from an innovative software-connected pipetting system, bringing improved reproducibility and traceability of experiments to life-science laboratories.
Corning Life Sciences to Feature 3D Cell Culture Technologies at SLAS 2019
Corning Life Sciences to Feature 3D Cell Culture Technologies at SLAS 2019
Corning Incorporated (NYSE: GLW) will showcase advanced 3D cell culture technologies and workflow solutions for spheroids, organoids, tissue models, and applications including ADME/toxicology at the Society for Laboratory Automation and Screening (SLAS) conference, Feb. 2-6 in Washington, D.C.