IDEAS home Printed from https://ideas.repec.org/a/oup/rseval/v31y2022i2p249-256..html
   My bibliography  Save this article

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.
    as

    Download full text from publisher

    File URL: http://hdl.handle.net/10.1093/reseval/rvac003
    Download Restriction: Access to full text is restricted to subscribers.
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:oup:rseval:v:31:y:2022:i:2:p:249-256.. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    We have no bibliographic references for this item. You can help adding them by using this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Oxford University Press (email available below). General contact details of provider: https://academic.oup.com/rev .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.