The Impact of COVID-19 on Clinical Trial Execution at the Dana-Farber Cancer Institute
Ce dossier présente un ensemble d'articles concernant la prise en charge des cancers durant la crise sanitaire liée au COVID-19
Interventions designed to limit the spread of COVID-19 are having profound effects on the delivery of healthcare, 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 (DFCI) 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/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 two-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 half the pre-pandemic rate. The median number of investigational prescriptions shipped to patients increased from 0-74 (range: 22-107) per week from March-June 2020. The median number of telemedicine appointments increased from 0-107 (range: 33-267) per week from March-June 2020. Research biopsies and blood collections decreased dramatically after DFCI 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.
Journal of the National Cancer Institute , résumé, 2019