“What is a mechanistic study?”

Funding News Edition: May 20, 2020
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NIH defines mechanistic studies as designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.

Not all mechanistic studies are clinical trials, but many are. To determine whether your research qualifies as a clinical trial, proceed through the Decision Tree for NIH Clinical Trial Definition and pay close attention to the third question: Is the study designed to evaluate the effect of the intervention on the participants?

The intervention must have the purpose of causing a health-related change that will be measured—absent that, the proposed research likely does not meet the NIH definition of a clinical trial. NIH gave examples of mechanistic studies that likely qualify as clinical trials in the October 25, 2017 Guide notice.

If you determine your mechanistic study is a clinical trial, learn about the requirements that follow on NIAID’s Clinical Trial Research page.

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Email us at deaweb@niaid.nih.gov for help navigating NIAID’s grant and contract policies and procedures.

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