Evaluating the Revised National Institutes of Health clinical trial definition impact on recruitment progress

Eugene I KaneIII, Gail L Daumit, Kevin M Fain, Roberta W Scherer and Emma Elizabeth McGinty

Research Evaluation, 2022, vol. 31, issue 2, 249-256

Abstract: BackgroundThe National Institutes of Health (NIH) announced a revised, expanded definition of ‘clinical trial’ in 2014 to improve trial identification and administrative compliance. Some stakeholders voiced concerns that the policy added administrative burden potentially slowing research progress.MethodsThis quasi-experimental study examined the difference-in-differences impact of the new NIH clinical trial definition policy on participant recruitment progress in grants funded by the National Institute of Mental Health (NIMH).ResultsOne hundred thirty-two funded clinical trial grants were identified. While more grants were identified as clinical trials under the revised definition, the difference-in-differences in recruitment progress before and after the policy change was not statistically significant.ConclusionsThe revised NIH clinical trial definition had no clear effect on recruitment progress in newly identified NIMH-funded clinical trials as compared to traditionally identified clinical trials. Concerns that administrative delays and burden could impact study progress may be alleviated by these initial results.

Keywords: National Institutes of Health clinical trial definition; research policy evaluation; clinical trial policy; clinical trial policy impact; clinical trial oversight (search for similar items in EconPapers)
Date: 2022
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