Analysis of Serious Adverse Event Reporting for Patients Enrolled in Cancer Clinical Trials During the COVID-19 Pandemic
Ce dossier présente un ensemble d'articles concernant la prise en charge des cancers durant la crise sanitaire liée au COVID-19
The COVID-19 pandemic affected cancer treatment in the context of usual care and clinical trials. Clinical trial activity and routine care were disrupted, allowing for limited new enrollments early in the pandemic. The proportion of remote visits and delayed nonessential surgeries or systemic therapies increased. Trials were prioritized based on disease severity and resource allocation.Increased remote monitoring on clinical trials may have implications for identification of toxic effects from treatment even while potentially increasing flexibility in trial participation and communication with physicians. Given the likely durable use of remote monitoring even after the pandemic abates, it is important to understand the implications of pandemic-related care delivery changes for safety monitoring in oncology clinical trials. The aim of the study was to evaluate the implications of the COVID-19 pandemic for serious adverse event (SAE) reporting for patients enrolled in oncology therapeutic clinical trials.
JAMA Oncology , article en libre accès, 2021