Coronavirus disease (COVID-19) outbreak and phase 1 trials: should we consider a specific patient management?

The outbreak of the Coronavirus disease (COVID-19) pandemic has deeply challenged healthcare systems and care of patients with cancer. Phase 1 studies are among the most complicated clinical trials and require thorough patient selection, as well as intensive patient monitoring. In this perspective, we discuss the key factors that should be considered for the conduct of phase 1 trials and management of COVID-19–positive patients with cancer enrolled in such trials. We notably present the risks and challenges raised by COVID-19–infected phase 1 patients, in terms of safety, toxicity causality assessment, drug efficacy evaluation and clinical research priorities. We finally propose some guidelines for the conduct of phase 1 trials and management of COVID-19–infected patients in a pandemic time.