Operationalizing Virtual Trials in Oncology—From Aspiration to Action

Abstract

COVID-19 has accelerated the virtualization of American medicine, from the decentralization of health services (eg, Hospital at Home) to the digiti-zation of clinical trials (eg, remote patient monitoring and real-time collection of study end points). 1,2 Although the transformation of care delivery models and research practices is generally decoupled in most medical specialties, these pandemic-era innovations uniquely converge in oncology, where the complexity of disease and the diversity of therapeutic modalities fosters a closer alignment between clinical care and the academic enterprise. For example, the clinical infrastructure used to expand home-based oncology care (eg, Penn Medicine's CC@H model) leveraged many of the same tools used to continue or initiate oncology trials under COVID-19 (eg, virtual site visits). 3,4 These trends raise a novel possibility that the delivery system itself can be a vehicle for restructuring the research enterprise in oncology. However, virtual clinical trials in oncology remain nascent despite demonstrated interest from regulators and sponsors. 5,6 Achieving this paradigm shift will require addressing a number of longstanding challenges in clinical research , including regulatory barriers and cultural resistance to change. In this article, we present different use cases of oncology trials to outline the key enablers for and barriers to operationalizing virtual trials in oncology. The Virtual Trials Paradigm The National Academy of Medicine uses virtual trials as an umbrella term for clinical research strategies (which have been described elsewhere in the literature as decentralized trials, technology-enabled trials, and direct-to-participant trials) that offer alternatives to in-person study requirements and brick-and-mortar research sites. 7-9