Nishiwaki Satoshi, Ando Yuichi
Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan.
Front Med (Lausanne). 2021 Dec 24;8:812370. doi: 10.3389/fmed.2021.812370. eCollection 2021.
To evaluate the effect of the COVID-19 pandemic on clinical development, the number of newly started clinical trials in each geographical region between January 2018 and December 2020 were calculated based on data from the ClinicalTrials.gov database. Data regarding new drug applications were obtained from European Medicines Agency monthly reports, pharmaceutical company press releases, and the archives of the Drugs.com database. The mean percentage change in newly started clinical trials for diseases other than COVID-19 between each month in 2019 and the corresponding month in 2020 was -7.5%, with the maximum of -57.3% observed between April 2019 and April 2020. Similarly, the mean percentage change of reported results for each month in 2019 and 2020 was -5.1%, with the maximum of -27.4% observed in July 2020. The activity of clinical trials was decreased as the number of COVID-19 patients was increased, and a statistically negative correlation was observed between the prevalence of COVID-19 and the percentage decrease in the number of clinical trials stared or reported results. As for new drug submissions, decreases were observed in the latter half of 2020 compared with the same period during the previous year, for each indicator. A considerable decline in non-COVID-19 activity for all indicators regarding clinical developments was suggested during the first wave of the COVID-19 pandemic. It is important to recognize the situation and continue to make efforts to conduct clinical trials for both COVID-19 and no-COVID-19 for new medical developments in the future.
为评估新冠疫情对临床研发的影响，基于美国国立医学图书馆临床试验数据库（ClinicalTrials.gov）的数据，计算了2018年1月至2020年12月期间每个地理区域新启动的临床试验数量。关于新药申请的数据来自欧洲药品管理局月度报告、制药公司新闻稿以及Drugs.com数据库档案。2019年各月与2020年对应月份相比，非新冠疾病新启动临床试验的平均百分比变化为-7.5%，2019年4月至2020年4月期间降幅最大，达-57.3%。同样，2019年和2020年各月报告结果的平均百分比变化为-5.1%，2020年7月降幅最大，达-27.4%。随着新冠患者数量增加，临床试验活动减少，新冠患病率与新启动或报告结果的临床试验数量下降百分比之间存在统计学负相关。至于新药提交情况，与上一年同期相比，2020年下半年各项指标均出现下降。在新冠疫情第一波期间，所有临床研发指标的非新冠活动均大幅下降。认识到这一情况并继续努力为未来新的医学发展开展针对新冠和非新冠疾病的临床试验非常重要。
