F-2 - Virtual Visits: Applications in Clinical Research Studies

The clinical trial environment is changing and expanding. To meet regulatory demands more studies are going global, increasing in duration and patients are participating in studies longer. In addition, there is an increasing interest in undertaking “remote” or “e” clinical trials where most of the clinical protocol assessments are undertaken away from the clinical site. Virtual/tele-visits, web-based surveys and hybrid studies represent particularly promising opportunities to streamline study conduct, support patients who have long/difficult travel to sites, reduces participant and family burden, may increase patient interactions, compliance and retention, and allows for the collection of data beyond the usual episodic, in-clinic assessments. Demonstrating the accuracy of these relatively inexpensive and accessible platforms for the measurement of disease progression would facilitate long-term follow-up of participants after completion of interventional studies. New infrastructure and assessment techniques will be required to implement tele-visit assessments.