Abstract PO-088: COVID-19 pandemic slows launch of oncology clinical trials
Authors: Lamont Elizabeth B. , Diamond Sheila S. , Katriel Ron G. , Lui Jingshu , Ensign Lisa , Alexander Caleb 
Published: December 2020

Abstract
Objective: The COVID-19 pandemic has caused global economic and social upheaval, including in the health care marketplace, yet its impact on clinical research and development has not been well described. We explored the effect of the pandemic on the launch of new clinical trials in oncology.
Methods: Using data from the Medidata Enterprise Data Store (MEDS), which captures nearly a third of global interventional drug/biologic clinical trials, we identified all oncology interventional drug/biologic clinical trials from years 2018-2020 across all trial phases (i.e., I-IV). We then selected trials that opened to accrual between October 2018-April 2019 (“pre-COVID-19” period) and October 2019-April 2020 (“COVID-19” period). We compared counts of new trial launches (i.e., new trials opening for patient accrual) during these two periods using negative binomial regression first for aggregated data and then according to trial phase.
Results: In aggregate, there were 1,144 interventional drug/biologic oncology trials launched in 60 countries during the study period, 753 during the pre-COVID-19 period and 391 during the COVID-19 period. This represents a 49% lower rate of trial launches during the COVID-19 period (incidence rate ratio [IRR] 0.51, 95% confidence interval [CI] 0.35-0.74). Evaluating the counts of new launches according to trial phase, we found 133 phase I trial launches in the pre-COVID-19 period and 105 during the COVID-19 period, representing a 21% reduction (IRR 0.79, 95% CI: 0.57-1.08); 148 new phase II trial launches in the pre-COVID-19 period and 63 during the COVID-19 period, representing a 57% reduction (IRR 0.43, 95% CI: 0.29-0.63); 91 new phase III trial launches in the pre-COVID-19 period and 32 during the COVID-19 period, representing a 65% reduction (IRR 0.35, 95% CI: 0.22-0.56); and four new phase IV trial launches in the pre-COVID-19 period and zero during the COVID-19 period.
Conclusion: The COVID-19 pandemic has been associated with an approximate 50% decrease in the number of interventional drug/biologic oncology clinical trials opened for patient accrual. The results further suggest that there may be some heterogeneity in the impact of COVID-19 according to trial phase, with phase I trial launches perhaps less compromised than phase II and phase III trial launches. Our study was limited to one clinical trial database and was not designed to identify the precise cause(s) of this slowdown. Potential contributors include redirection of study resources to COVID-19 treatment and prevention trials, efforts to minimize COVID-19 transmission to trial participants and research teams, and supply chain interruptions.
Citation Format: Elizabeth B. Lamont, Sheila S. Diamond, Ron G. Katriel, Jingshu Lui, Lisa Ensign, Caleb Alexander. COVID-19 pandemic slows launch of oncology clinical trials [abstract]. In: Proceedings of the AACR Virtual Meeting: COVID-19 and Cancer; 2020 Jul 20-22. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(18_Suppl):Abstract nr PO-088.