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

Author

Listed:
  • Eugene I KaneIII
  • Gail L Daumit
  • Kevin M Fain
  • Roberta W Scherer
  • Emma Elizabeth McGinty

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.

Suggested Citation

  • Eugene I KaneIII & Gail L Daumit & Kevin M Fain & Roberta W Scherer & Emma Elizabeth McGinty, 2022. "Evaluating the Revised National Institutes of Health clinical trial definition impact on recruitment progress," Research Evaluation, Oxford University Press, vol. 31(2), pages 249-256.
    • Handle: RePEc:oup:rseval:v:31:y:2022:i:2:p:249-256.
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    File URL: http://hdl.handle.net/10.1093/reseval/rvac003
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    Cited by:

    1. Xin Li & Xuli Tang & Wei Lu, 2024. "How biomedical papers accumulated their clinical citations: a large-scale retrospective analysis based on PubMed," Scientometrics, Springer;Akadémiai Kiadó, vol. 129(6), pages 3315-3339, June.

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