Regulatory Focus™ > News Articles > NIH Initiative Hopes to Improve How Preclinical Testing is Reported

NIH Initiative Hopes to Improve How Preclinical Testing is Reported

Posted 11 October 2012 | By

The National Institutes of Health (NIH) has announced a set of consensus recommendations it says will improve the way preclinical animal studies are designed and conducted, ultimately making them easier to reproduce and understand.

The problem, explains NIH, is the gap between conducting animal studies and being able to study the effect of a drug in human trials. "Positive results from animal studies are sometimes difficult to translate into successful clinical trials," NIH said. The broader translational issues of turning an experimental therapy into one approved for use in humans is often referred to as the "Valley of Death," so-named because of the high attrition rate for therapies seeking market access.

A panel of experts convened by NIH said their recommendations are aimed at confronting the challenges facing sponsors at the earliest stages of the Valley, when they conduct preclinical studies on animals. "Our goal is to ensure that preclinical animal studies are reported in sufficient detail so that funding agencies, scientific journals and the broader scientific community can adequately review the research and decide how to move forward," said Story Landis, director of NIH's National Institute of Neurological Disorders and Stroke (NINDS).

NINDS' recommendations say that completed animal studies should be published along with four key details: whether the study was randomized, whether the study was blinded, an estimate of the sample size and information about the handling of data.

A lack of information about all four factors currently makes it more difficult to assess the quality of reported animal studies, which can ultimately lead to wasted resources as companies and scientists needlessly duplicate studies to find evidence of an effect.

These recommendations will take time to come into effect, workshop participants conceded.

"Achieving a meaningful change will require the cooperation of funding agencies, journal editors and investigators, including those who volunteer their time to review scientific manuscripts and grant applications," they said.

NINDS has already moved to make its recommendations known to NIH grant applicants, publishing a notice in NIH's Guide for Grants and Contracts, but is still seeking other methods to, "Encourage broad adoption," including providing training to investigators and the creation of a checklist.

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