The Impact of COVID-19 on Clinical Trial Execution at the Dana-Farber Cancer Institute

Abstract

Interventions designed to limit the spread of coronavirus disease 2019 (COVID-19) are having profound effects on the delivery of health care, but data showing the impact on oncology clinical trial enrollment, treatment, and monitoring are limited. We prospectively tracked relevant data from oncology clinical trials at Dana-Farber Cancer Institute from January 1, 2018, to June 30, 2020, including the number of open trials, new patient enrollments, in-person and virtual patient visits, dispensed investigational infusions, dispensed or shipped oral investigational agents, research biopsies, and blood samples. We ascertained why patients came off trials and determined on-site clinical research staffing levels. We used 2-sided Wilcoxon rank sum tests to assess the statistical significance of the reported changes. Nearly all patients on interventional treatment trials were maintained, and new enrollments continued at just under one-half the prepandemic rate. The median number of investigational prescriptions shipped to patients increased from 0 to 74 (range = 22-107) per week from March to June 2020. The median number of telemedicine appointments increased from 0 to 107 (range = 33-267) per week from March to June 2020. Research biopsies and blood collections decreased dramatically after Dana-Farber Cancer Institute implemented COVID-19-related policies in March 2020. The number of research nurses and clinical research coordinators on site also decreased after March 2020. Substantial changes were required to safely continue clinical research during the pandemic, yet we observed no increases in serious adverse events or major violations related to drug dosing. Lessons learned from adapting research practices during COVID-19 can inform industry sponsors and governmental agencies to consider altering practices to increase operational efficiency and convenience for patients.

Figure 1.

Number of patients enrolled in trials by month, January 2019 to June 2020. A) Number of patients who enrolled in interventional, therapeutic trials by month, January 2019 to June 2020. B) Number of patients who enrolled in interventional, nontherapeutic trials by month, January 2019 to June 2020. C) Number of patients who enrolled in noninterventional, nontherapeutic trials by month, January 2019 to June 2020. Two-sided Wilcoxon rank sum tests were used to compare the number of patients enrolled across the 3 time periods: 2018-February 2020, March-May 2020, and June 2020.

Figure 2.

Changes in oral investigational  agent distribution, appointment setting, and missed appointments from January 2020 to June 2020. A) Number of oral investigational agents dispensed in person vs shipped to patients by week, January 2020 to June 2020. B) Number of adult appointments conducted in-person and using telemedicine, January 2020 to June 2020. C) Number of pediatric appointments conducted in-person and using telemedicine, January 2020 to June 2020. D) Number of adult missed appointments, in-person and via telemedicine, January 2020 to June 2020.