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评估2019冠状病毒病对已注册的介入性临床试验的影响。

Assessing the impact of COVID-19 on registered interventional clinical trials.

作者信息

Hawila Nour, Berg Arthur

机构信息

Department of Public Health Science, Division of Biostatistics & Bioinformatics, Penn State College of Medicine, Hershey, Pennsylvania, USA.

出版信息

Clin Transl Sci. 2021 May;14(3):1147-1154. doi: 10.1111/cts.13034. Epub 2021 May 8.

Abstract

The coronavirus disease 2019 (COVID-19) pandemic has led to a dramatic impact worldwide and presented unprecedented challenges for clinical and translational medicine. We assess the impact of COVID-19 on submitted and completed interventional clinical trials that have been registered on ClinicalTrials.gov. After classifying over 85% of the registered clinical trials by their source, we carefully model the number of submitted and completed trials before and after March 2020. Overall, we find minimal impact of COVID-19 on the number of submitted clinical trials, although a much more substantial impact is observed for completed clinical trials. We also show that clinical trials with a pharmaceutical sponsor were more successful at completing trials during the pandemic compared to the trials with academic/hospital/government sponsors.

摘要

2019年冠状病毒病(COVID-19)大流行在全球范围内产生了巨大影响,并给临床和转化医学带来了前所未有的挑战。我们评估了COVID-19对已在ClinicalTrials.gov上注册的已提交和完成的干预性临床试验的影响。在按来源对超过85%的注册临床试验进行分类后,我们仔细模拟了2020年3月前后提交和完成的试验数量。总体而言,我们发现COVID-19对提交的临床试验数量影响极小,尽管对已完成的临床试验观察到的影响要大得多。我们还表明,与由学术/医院/政府赞助的试验相比,由制药公司赞助的临床试验在大流行期间完成试验的成功率更高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2a1a/8212742/6ce5835b6e58/CTS-14-1147-g004.jpg

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