Trials without borders—decentralized trials and ensuring access to novel cancer therapies during a global pandemic

[摘要] We read with great interest the recent review by Sessaet al.1 detailing the impact of COVID-19 on oncologyresearch. The pandemic necessitated significant changes incancer clinical trial conduct.2 Correspondingly, regulatorybodies issued detailed guidance for contingency measures,on remote study visits, delivery of investigational product(IP), and site monitoring visits.1 Two years on, however,with increasing uptake of vaccinations and lifting of restrictions across regions, many trials may simply return topre-pandemic standard practices. There is a significantchallenge to translate and implement the most costeffective operational approaches for future trials. To thisend, we present a single-centre case study on the impact ofCOVID-19 on trial conduct in an early phase trials unit in anacademic cancer centre demonstrating the feasibility oflong-term adaptations incorporating a decentralized trialsmodel.

[学科分类] 社会科学、人文和艺术（综合）