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

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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