Potential benefits and burdens of National Institutes of Health and National Institute of Mental Health clinical trial policies.

The National Institutes of Health (NIH) and the National Institute of Mental Health (NIMH) have implemented numerous clinical trial policies in recent years. These policies have well-intended goals but concerns of undue burden have been raised by professional societies. This study identified the new and revised NIH and NIMH clinical trial policies from 2005 to 2019 and summarized the publicly-identified potential benefits and burdens of those policies. Five new/revised NIH-wide and four NIMH-only clinical trial policies were identified. Potential benefits were improved identification, review, conduct, and reporting of publicly-funded clinical trials. Potential burdens were loss of researcher time, potential loss of future research funding opportunities for basic behavioral researchers, and researcher confusion resulting from perceived definition overlap between clinical trials and basic science. Future clinical trial policy development may benefit from early engagement of researchers as stakeholders. Policymakers may benefit from publicly incorporating benefit/burden analyses and outcome evaluations into future policy development.