The New Normal: Decentralized Clinical Trials

What is Virtualization of clinical trials?

Virtual(ized) clinical trials, also known as hybrid trials, decentralized trials, remote trials, and direct-to-patient trials is a relatively new method of conducting clinical trials by which parts or all of the trial happen outside of a traditional physical clinic or trial site. Medidata addresses virtualization of clinical trials in two critical areas: patient-facing activities as well as site-based study oversight and management. When virtualizing any aspect of a clinical trial - the site and the patient are directly impacted with the use of such technologies. Patient-facing solutions are designed to lower the burden placed on trial subjects to learn new technologies, to limit the number of devices to carry with multiple logins and to facilitate access to remote data capturing tools. With myMedidata, Medidata’s patient portal, patients can access all of their clinical trial needs through one web-based portal removing the need for provisioned devices. At the site level, Medidata solutions such as Remote Source Review and Centralized Monitoring provide site monitors remote access to physical sites so they can continue to monitor source data and documents.

This following article addresses some frequently asked questions about virtualized clinical trials including key considerations, sponsor requirements, patient recruitment, and regulatory concerns.