Quantifying the impact of the COVID-19 pandemic on clinical trial screening rates over time in 37 countries

被引:22
作者
McDonald, Kelsey [1 ]
Seltzer, Earl [1 ]
Lu, Mary [1 ]
Gaisenband, Stefan Diaz [1 ]
Fletcher, Cassandra [1 ]
McLeroth, Patrick [1 ]
Saini, Kamal S. [1 ,2 ]
机构
[1] Labcorp Drug Dev Inc, 206 Carnegie Ctr Dr, Princeton, NJ 08540 USA
[2] Cambridge Univ Hosp NHS Fdn Trust, Addenbrookes Hosp, Cambridge, England
关键词
COVID-19; Coronavirus; Pandemic; Clinical trials; Screening; Enrollment; SARS-CoV-2; Global; Impact; Recruitment;
D O I
10.1186/s13063-023-07277-1
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
The COVID-19 pandemic has had an unprecedented and disruptive impact on people's health and lives worldwide. In addition to burdening people's health in the short-term in the form of infection, illness, and mortality, there has been an enormous negative impact on clinical research. Clinical trials experienced challenges in ensuring patient safety and enrolling new patients throughout the pandemic. Here, we investigate and quantify the negative impact that the COVID-19 pandemic has industry-sponsored clinical trials, both in the USA and worldwide. We find a negative correlation between the severity of the COVID-19 pandemic and clinical trial screening rate, with the relationship being strongest during the first three months of the pandemic compared to the entire duration of the pandemic. This negative statistical relationship holds across therapeutic areas, across states in the USA despite the heterogeneity of responses at the state-level, and across countries. This work has significant implications for the management of clinical trials worldwide in response to the fluctuating severity of COVID-19 moving forward and for future pandemics.
引用
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页数:10
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