评估美国国立卫生研究院修订后的临床试验定义对招募进展的影响。
Evaluating the Revised National Institutes of Health Clinical Trial Definition Impact on Recruitment Progress.
作者信息
Kane Eugene I, Daumit Gail L, Fain Kevin M, Scherer Roberta W, McGinty Emma Elizabeth
机构信息
Office of Clinical Research, National Institute of Mental Health, National Institutes of Health, Bethesda, MD 20882, USA.
Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.
出版信息
Res Eval. 2022 Apr;31(2):249-256. doi: 10.1093/reseval/rvac003. Epub 2022 Feb 17.
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.
背景
美国国立卫生研究院（NIH）于2014年宣布了对“临床试验”的修订和扩展定义，以改善试验识别和行政合规性。一些利益相关者担心该政策增加了行政负担，可能会减缓研究进展。
方法
这项准实验研究考察了NIH新的临床试验定义政策对美国国立精神卫生研究所（NIMH）资助的拨款中参与者招募进展的双重差分影响。
结果
确定了132项获得资助的临床试验拨款。虽然根据修订后的定义，更多的拨款被确定为临床试验，但政策变化前后招募进展的双重差分在统计学上并不显著。
结论
与传统认定的临床试验相比，NIH修订后的临床试验定义对新认定的NIMH资助的临床试验的招募进展没有明显影响。这些初步结果可能会缓解对行政延误和负担可能影响研究进展的担忧。
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