Virtual Clinical Trials

COVID-19 has changed so much about how we live our daily lives. Innovation and creativity have helped businesses quickly make the changes need to keep them running in the wake of social distancing requirements. For instance, restaurants opened curbside services where patrons can pick up their favorite meal with a call ahead. In the medical realm, virtual appointments surfaced, minimizing the need to ever leave home for healthcare needs.

In the research world, virtual clinical trials were slowly making their way into the picture for years but many sites, sponsors and CROs were hesitant to adopt the trend. Now that we’re living in the COVID era, those who haven’t adopted a virtual trial model are being left behind.

What are Virtual Clinical Trials?

A virtual clinical trial, also referred to as a decentralized clinical trials, is a term that means different things depending on who you ask. Some believe that the utilization of patient-facing technologies such as smartphone apps, tablets, or wearable technologies are the key factors of a virtual trial. Others believe that a virtual trial includes no patient-to-staff direct interactions at all. The FDA leans more to the latter definition to combat the challenges faced by sites amid the COVID-19 pandemic.

Regardless of how you interpret what a virtual trial means, the reality is that most clinical trials being conducted today, and likely for the foreseeable future, still have a need for direct site-to-patient contact.

What Virtual Trials mean to the Clinical Research Industry?

Virtual clinical trials bring more to the research industry than just increasing patient engagement when engagement is more challenging. Conducting clinical trials virtually allows sponsors and CROs greater visibility and oversight of real-time study data and documents.

Allowing patients an opportunity to have some of their visits done virtually saves the time and effort associated with office visits and limits direct contact with site staff. Gathering patient information through digital eSOURCE forms, wearables, apps, and tablets streamline the gathering and reporting of data, and greatly improves sponsor and CRO oversight and data analysis without on-site monitoring. Virtual clinical trials can widen the pool of participants and improve the efficiency and trials management for all parties.

In short, virtual trials allow the ability for monitors to remotely access and monitor data and patient information, reducing travel costs and increasing efficiency.

Virtual Clinical Trials with the Florida Institute for Clinical Research

Florida Institute for Clinical Research incorporates virtual clinical trial technologies, as-needed, for our Sponsors and CROs. Our state-of-the-art capabilities and equipment ensure maximum safety and ease of participation for our volunteers. Our RealTime-CTMS system with electronic source allows our partners to review and monitor data remotely, anywhere.

To learn more about our current and upcoming enrolling research studies, call (407) 658-0966, or click here.

References:

https://www.clinicalleader.com/doc/what-exactly-is-a-virtual-clinical-trial-0001

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-guidance-conducting-clinical-trials

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