Quantifying the Impact of the COVID-19 Pandemic on Clinical Trial Enrollment Rates Over Time in 37 Countries

Abstract

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 United States and worldwide. We find a negative correlation between the severity of the COVID-19 pandemic and clinical trial enrollment 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 US 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.

The Impact of COVID-19 on US Clinical Trial Activity

“…For example, industry observers and participants shared concerns about the expected slowdown in clinical trial activity [1][2][3][4][5]. Using a range of methodologies from site surveys, to case studies, to on-line publication and citation reviews, individual analyses across a range of therapeutic areas and geographies reported initially slower enrollments [6][7][8][9][10][11][12]. However, throughout many of these reports, the clinical trial professionals also reported changes introduced to maintain study enrollment, keep both patients and employees safe, change the way they conducted clinical research and even how the people running the trials might analyze datasets with increasing amounts of missing data [13][14][15][16][17][18][19][20].…”