Decentralized Clinical Trials in Early Drug Development—A Framework Proposal

The COVID-19 pandemic has led to a rethinking of clinical trial design to maintain clinical research activity, with regulatory changes allowing for the wider implementation and development of decentralized design models. Evidence of the feasibility and benefits associated with a remote design comes mainly from observational studies or phase 2 and 3 clinical trials, in which implementation is easier with a better-established safety profile. Early drug development is a slow and expensive process in which accrual and safety are key aspects of success. Applying a decentralized model to phase 1 clinical trials could improve patient accrual by removing geographic barriers, improving patient population diversity, strengthening evidence for rare tumors, and reducing patients’ financial and logistical burdens. However, safety monitoring, data quality, shipment, and administration of the investigational product are challenges to its implementation. Based on published data for decentralized clinical trials, we propose an exploratory framework of solutions to enable the conceptualization of a decentralized model for phase 1 clinical trials.