Hawila Nour, Berg Arthur
Department of Public Health Science, Division of Biostatistics & Bioinformatics, Penn State College of Medicine, Hershey, Pennsylvania, USA.
Clin Transl Sci. 2021 May;14(3):1147-1154. doi: 10.1111/cts.13034. Epub 2021 May 8.
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.
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。
