Oncology trial enrollment trends following the first wave of the COVID-19 pandemic

Lamont, E. W.; Blum, K.; Katriel, R. G.; Ensign, L. G.

Background: The first wave of the COVID-19 pandemic was associated with a negative effect on global oncology clinical research and development including documented decreases in new trial launches and patients enrolling on existing trials. We sought to evaluate secular trends in patient enrollment on global oncology trials of drugs and/or biological agents coincident with trends in the pandemic through 10/31/2020. Methods: This time-series study of global oncology clinical trial patient enrollment relied on data from the Medidata Enterprise Data Store, which comprises studies using the RAVE electronic data capture platform, and eCDC. We quantified the number of patients enrolling on oncology trials according to contiguous pandemic waves between 01/05/2020 and fixed right censoring at 10/31/2020. For this study, we defined pandemic waves empirically through review of peaks and nadirs of global case counts/week from eCDC data: wave 1 (01/05/2020- 05/02/2020), wave 2 (05/03/2020-08/22/2020), wave 3 (08/23/2020-10/31/2020). We used negative binomial regressions to evaluate associations between time periods (i.e., waves) and counts of new trial enrollees and time periods and counts of new COVID-19 patients. Results: A total of 54,752 patients enrolled in 1,176 oncology trials world-wide during the observation period: 14,888 patients during wave 1, 19,631 patients during wave 2, and 20,233 patients during wave 3 of the pandemic. Compared to wave 1, the incidence of new trial enrollees increased by 10% in wave 2 (incidence rate ratio [IRR] 1.10, 95% confidence interval [CI] 0.95-1.26) and by 29% in wave 3 (IRR 1.29, 95% CI: 1.10-1.52). Over the same period, 47,336,995 people were diagnosed with COVID-19 infection: 3,481,165 patients during wave 1, 20,205,244 patients during wave 2, and 23,650,586 patients during wave 3. Compared to wave 1, the incidence of new COVID-19 patients increased by 617% in wave 2 (IRR 6.17, 95% CI: 2.76-13.77) and by 1,155% (IRR 11.55, 95% CI: 4.61-28.95) in wave 3. Conclusions: Despite substantial increases in the incidence of COVID19 following the first wave of the pandemic, the number of patients enrolled in oncology clinical trials increased notably during the same period. Future research seeks to understand the mechanism through which the oncology research and development enterprise adapted to the shock of the COVID-19 pandemic.