ERIC Number: EJ1334655
Record Type: Journal
Publication Date: 2022-Apr
Pages: 8
Abstractor: As Provided
ISBN: N/A
ISSN: ISSN-0958-2029
EISSN: N/A
Evaluating the Revised National Institutes of Health Clinical Trial Definition Impact on Recruitment Progress
Kane, Eugene I., III; Daumit, Gail L.; Fain, Kevin M.; Scherer, Roberta W.; McGinty, Emma Elizabeth
Research Evaluation, v31 n2 p249-256 Apr 2022
Background: The 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. Methods: This 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). Results: One 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. Conclusions: The 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.
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Publication Type: Journal Articles; Reports - Research
Education Level: N/A
Audience: N/A
Language: English
Sponsor: N/A
Authoring Institution: N/A
Grant or Contract Numbers: N/A