Capitalizing on advances in mobile health and digital technologies, Decentralized Clinical Trials (also known as Remote & Virtual Trials) can address traditional hurdles such as sizable and costly infrastructure as well as recruitment and regulatory challenges. These trials are led and coordinated by a local investigative team, but are based remotely, within a given community, state, nation, etc. The remote approach affords many of the benefits of multi-site trials without the same barriers.
Methods to support decentralized trials may include:
- remote recruitment and screening
- tele-consent
- remote assessment, including use of digital platforms to capture data in real time
- biomarker collection and biosensor data integration
- medication adherence monitoring
- adverse event monitoring
- participant remuneration
