Eugene I Kane1, Gail L Daumit2,3,4, Kevin M Fain5, Roberta W Scherer4, Emma Elizabeth McGinty3. 1. Office of Clinical Research, National Institute of Mental Health, National Institutes of Health, Bethesda, MD 20882, USA. 2. Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA. 3. Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA. 4. Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA. 5. Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20903, USA.
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: 132 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.
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: 132 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.
Entities:
Keywords:
Clinical Trial Oversight; Clinical Trial Policy; Clinical Trial Policy Impact; National Institutes of Health Clinical Trial Definition; Research Policy Evaluation
Authors: Eugene I Kane; Gail L Daumit; Kevin M Fain; Roberta W Scherer; Emma Elizabeth McGinty Journal: Contemp Clin Trials Date: 2021-02-22 Impact factor: 2.226
Authors: Diane Whitham; Julie Turzanski; Lucy Bradshaw; Mike Clarke; Lucy Culliford; Lelia Duley; Lisa Shaw; Zoe Skea; Shaun P Treweek; Kate Walker; Paula R Williamson; Alan A Montgomery Journal: Trials Date: 2018-10-16 Impact factor: 2.279