A Blueprint for the Conduct of Large, Multisite Trials in Telemedicine

Abstract

Recent literature supports the efficacy and efficiency of telemedicine in improving various health outcomes despite the wide variability in results. Understanding site-specific issues in the implementation of telemedicine trials for broader replication and generalizability of results is needed. Lessons can be learned from existing trials, and a blueprint can guide researchers to conduct these challenging studies using telemedicine more efficiently and effectively. This viewpoint presents relevant challenges and solutions for conducting multisite telemedicine trials using 7 ongoing and completed studies funded by the Patient-Centered Outcomes Research Institute portfolio of large multisite trials to highlight the challenges in implementing telemedicine trials. Critical issues of ensuring leadership and buy-in, appropriate funding, and diverse and representative trials are identified and described, as well as challenges related to clinical, informatics, regulatory, legal, quality, and billing. The lessons learned from these studies were used to create a blueprint of key aspects to consider for the design and implementation of multisite telemedicine trials.

Multi-centric clinic trials in evidence-based research – A narrative review on the Indian scenario

“…They have to verify the individual observations, monitor serious adverse reactions, and exclude a participating centre because of a dearth of solid data. [ 10 11 12 13 ]…”

“…Face-to-face meetings between the collaborators are an important and successful team building activity that is required to make this kind of progress. [ 9 10 11 12 13 14 15 16 ]…”