Chapter 15 - A single-center “virtual” trial with patients across the USA

Abstract

Virtual clinical trials are there to stay. Either in their entirety or as elements of a more conventional model, there is a potential for substantial benefits for patients, investigators, healthcare providers, and sponsors. Patient engagement is paramount for recruitment, retention, and data quality and needs to be thoroughly considered, both in studies with and without face-to-face interaction. The infrastructure and technology needed for virtual clinical studies is readily available, and the first virtual study has been successfully conducted. Regulatory authorities are supportive of this innovative approach as long as the fundamental patient rights, confidentiality, and safety are not compromised; however, the suitability of virtual trials needs to be assessed on a case-by-case basis. Even in a more conventional clinical trial setting, the available technology allows for substantial improvements in patient recruitment, consent, engagement, and retention; and data collection and handling as well as site selection and management can be substantially improved, potentially resulting in improved data quality, reduced timelines, and significant cost savings.