Evaluating the Revised National Institutes of Health Clinical Trial Definition Impact on Recruitment Progress.

IF 2.9 4区管理学 Q1 INFORMATION SCIENCE & LIBRARY SCIENCE

Research Evaluation Pub Date : 2022-04-01 Epub Date: 2022-02-17 DOI:10.1093/reseval/rvac003

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

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引用次数: 1

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.

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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。

背景:美国国立卫生研究院(NIH)于2014年公布了一项修订的、扩展的“临床试验”定义，以改善试验识别和行政合规。一些利益相关者表示担心，该政策增加了行政负担，可能会减缓研究进展。方法:本准实验研究考察了新的美国国立卫生研究院临床试验定义政策对国家精神卫生研究所(NIMH)资助的参与者招募进展的差异中的差异影响。结果:确定了132项临床试验资助。虽然根据修订的定义，更多的赠款被确定为临床试验，但政策改变前后招募进展的差异在统计上并不显著。结论:与传统临床试验相比，修订后的NIH临床试验定义对新确定的nimh资助临床试验的招募进展没有明显影响。对行政延误和负担可能影响研究进展的担忧可能会因这些初步结果而减轻。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Research Evaluation INFORMATION SCIENCE & LIBRARY SCIENCE-

CiteScore

6.00

自引率

18.20%

发文量

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.