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

Abstract

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.

Status of pediatric echocardiography clinical trials: a cross-sectional study of registered trials in ClinicalTrials.gov

“…Multivariable analysis found that union country was associated with publication within 24 months after trial completion, but single was not. Several factors may help to explain the difference in publication rate; an essential factor in this discrepancy may be publication bias, as basic results are required to report for clinical trials funded by all National Institutes of Health (HIH) ( 28 ). Trials from multiple countries may have adequate patient accrual, funding source, and are more likely to report results ( 29 , 30 ).…”