Eugene I Kane, Gail L Daumit, Kevin M Fain, Roberta W Scherer, Emma Elizabeth McGinty
{"title":"评估修订后的美国国立卫生研究院临床试验定义对招募进展的影响。","authors":"Eugene I Kane, Gail L Daumit, Kevin M Fain, Roberta W Scherer, Emma Elizabeth McGinty","doi":"10.1093/reseval/rvac003","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":47668,"journal":{"name":"Research Evaluation","volume":"31 2","pages":"249-256"},"PeriodicalIF":2.9000,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9558491/pdf/nihms-1840571.pdf","citationCount":"1","resultStr":"{\"title\":\"Evaluating the Revised National Institutes of Health Clinical Trial Definition Impact on Recruitment Progress.\",\"authors\":\"Eugene I Kane, Gail L Daumit, Kevin M Fain, Roberta W Scherer, Emma Elizabeth McGinty\",\"doi\":\"10.1093/reseval/rvac003\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":47668,\"journal\":{\"name\":\"Research Evaluation\",\"volume\":\"31 2\",\"pages\":\"249-256\"},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2022-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9558491/pdf/nihms-1840571.pdf\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Research Evaluation\",\"FirstCategoryId\":\"91\",\"ListUrlMain\":\"https://doi.org/10.1093/reseval/rvac003\",\"RegionNum\":4,\"RegionCategory\":\"管理学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2022/2/17 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"INFORMATION SCIENCE & LIBRARY SCIENCE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Research Evaluation","FirstCategoryId":"91","ListUrlMain":"https://doi.org/10.1093/reseval/rvac003","RegionNum":4,"RegionCategory":"管理学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/2/17 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"INFORMATION SCIENCE & LIBRARY SCIENCE","Score":null,"Total":0}
Evaluating the Revised National Institutes of Health Clinical Trial Definition Impact on Recruitment Progress.
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.
期刊介绍:
Research Evaluation is a peer-reviewed, international journal. It ranges from the individual research project up to inter-country comparisons of research performance. Research projects, researchers, research centres, and the types of research output are all relevant. It includes public and private sectors, natural and social sciences. The term "evaluation" applies to all stages from priorities and proposals, through the monitoring of on-going projects and programmes, to the use of the results of research.