Conducting a three-country clinical trial during the COVID-19 pandemic: experience and future considerations

Abstract

The global SARS-COV-2 pandemic has significantly impacted the delivery of clinical care as well as the conduct of international clinical trials. A coordinated, multinational acupuncture study, consisting of three parallel randomized studies with a planned pooled analysis of individual patient data, was initiated in 2019 with the goal of assessing whether acupuncture relieved hot flash symptoms in hormone receptor-positive breast cancer patients prescribed adjuvant endocrine therapy. Eligibility included persistent hot flashes on endocrine therapy. Participants were randomly assigned to receive either immediate or delayed acupuncture in equal proportions; the primary endpoint was assessed at week 10, after completion of the immediate acupuncture treatments and before the delayed treatment sessions began. The trial was conducted in China, South Korea and United States of America (USA) and was in the midst of enrollment and study procedures when the COVID-19 pandemic began. Despite numerous challenges, the study was nonetheless completed successfully. We deployed a process evaluation method to describe each site’s experiences in conducting this multinational study during the pandemic. Using these observations, we offer measures for the planning and conduct of future studies, taking into account preparedness considerations in the event of exigent and demanding global circumstances.