Direct Path to Patient
Virtual trials are designed to allow patients to participate from home, with the support of home health nurses. A patient centric approach uses tele-medicine (mHealth) to enable patient recruitment, gain informed consent, measure clinical endpoints, and monitor any adverse events from the patient’s home.6 This provides an innovative and more direct path to patients, taking trials directly to them, and offering a more attractive way for diverse and geographically distant individuals to participate.
The principal investigator is located remotely and supported by a virtual care team (see diagram). This model provides for better physician oversight and round-the-clock data collection – rather than the infrequent site visits involved in traditional clinical trials. This offers advantages for investigators, who are able to “see” more patients. Moreover, it reduces variability in assessments and data, and provides greater visibility into safety events. Investigators also benefit from technology to support tasks such as issuing alerts and notifications, scheduling, and reporting, freeing up their time to focus on research.