Patient Centricity And Virtualizing Technologies In A COVID-19 World

Measuring how the pandemic is driving adoption of digital tools in fully virtual, hybrid, and traditional clinical trials

As the COVID-19 pandemic rages on, clinical trial conduct is being reimagined in ways few thought possible not so long ago. Stakeholders are rethinking how to develop protocols, consent patients, ensure compliance, and gather quality clinical trial data when patients and staff are remote, rather than located at traditional trial sites. As this shift is unfolding, patient centricity has stepped to the forefront, allowing studies to continue, and helping researchers move closer to developing greatly needed vaccines and therapies for COVID-19, and for many other conditions.

Patient centricity is a growing and important movement within clinical trials, and although an official industry-wide definition is lacking¹, sponsors often refer to it as adopting a culture that puts patients first. This means embracing processes that enable fewer protocol assessments or involve greater use of virtual patient-facing technologies in clinical trials.² As part of this effort, digital tools enabling remote participation in trials are being introduced to simplify how patients participate in studies and communicate with sites. Some examples include tools for electronic clinical outcomes assessments (eCOA), wearables, and televisits. These solutions give patients a voice in ongoing studies at a time when many aspects of clinical trials are quickly becoming decentralized, meaning they are  being conducted either completely or partially outside of a traditional trial site via telemedicine and other remote mobile solutions.³ Although these virtualizing technologies have been available for several years, adoption has been slow. All of that changed with the pandemic, resulting in a stunning transition to digital tools designed to keep studies going4 as patient centricity is being repositioned as a standard practice.

This is a fast-changing picture, with new information constantly filtering in as to how sites are adapting to the COVID-19 era, and how patient-centric solutions are playing a growing role. To quantify this trend, the Society for Clinical Research Sites (SCRS) recently collaborated with Medidata (a Dassault Systemes Company) to conduct an online survey. It measured current and anticipated levels of adoption of patient-centric tools, and the sites’ perspective on how patients have reacted to them. Importantly, results counter the belief of many sponsors that sites are resistant to more digital tools. The survey revealed that sites are receptive to virtualizing technologies that facilitate their work while enhancing the patient experience.