National Institute of Mental Health Recruitment Monitoring Policy and Clinical Trial Impact

Eugene I. Kane, Gail L. Daumit, Kevin M. Fain, Brendan Saloner, Roberta W. Scherer, Emma Elizabeth McGinty

Research output: Contribution to journalArticlepeer-review

Abstract

Background/aims: The National Institutes of Health (NIH) implemented a recruitment milestone and progress reporting policy in fiscal year 2019. While too recent to evaluate, the National Institute of Mental Health (NIMH) previously implemented a similar policy in fiscal year 2006 which may forecast likely effects of the NIH-wide policy. Methods: An observational, single-group, pre/post evaluation of the association between the NIMH policy and the Relative Citation Ratio was conducted for non-fellowship, competing clinical trial grants funded from fiscal years 2004–2007. Results: 124 clinical trial grants were identified. After adjusting for covariates, the clinical trial grants subject to the NIMH recruitment monitoring policy were associated with a statistically significant mean-per-grant citation ratio (citations relative to the field norm) 1.98 times that of the clinical trial grants that were not subject to the policy (p = 0.005; 95% CI: [1.23, 3.20]). The clinical trial grants subject to the policy were also associated with a non-statistically significant 1.58 times maximum-per-grant citation ratio compared to the clinical trial grants not covered by the policy (p = 0.24; 95% CI: [0.73, 3.44]). Conclusions: The NIMH recruitment monitoring and reporting policy was associated with a statistically significant increase in the mean-per-grant Relative Citation Ratio. NIMH-specific results suggest that the NIH-wide policy might also be positively associated with improved Relative Citation Ratio.

Original languageEnglish (US)
Article number106312
JournalContemporary Clinical Trials
Volume103
DOIs
StatePublished - Apr 2021

Keywords

  • Clinical trial evaluation
  • Clinical trial impact
  • Clinical trial oversight
  • Participant recruitment monitoring
  • Policy evaluation

ASJC Scopus subject areas

  • Pharmacology (medical)

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