By Chris Varner, Project Manager, Virtual Trial Solutions
As with many technological innovations, the pharmaceutical industry was initially slow to embrace virtual trials. But COVID-19 accelerated interest in the use of these tools as a way to keep trials running through the pandemic.
It was an unexpected shift, but it has helped many sponsors and sites see the value of virtual for clinical research and identify where and when virtual trial elements may bring permanent benefits to clinical research, even after the pandemic is over.
Trials in crisis
When the pandemic hit, trial sites rapidly shut down, CRAs faced travel bans, and study participants became unwilling or unable to attend scheduled appointments. Sponsors and their partners scrambled to find ways to keep patients safe and trials on track.
Regulators were quick to step in, and their advice was clear: virtual trials may offer the best solutions for maintaining trial continuity.
Within weeks, virtually every regulatory body in the world published guidance documents or advice suggesting the adoption of virtual trial elements. These included remote monitoring, televisits, homehealth visits, and delivering investigational drugs directly to patients. Even regulators that have been historically opposed to virtual trials allowed for their limited use when appropriate during the pandemic.
Virtual trial solutions gave sponsors a much-needed lifeline to continue their research. The support from regulators indicated that agencies see virtual components and patient-centric technologies as a viable solution in this crisis, giving site leaders a roadmap to keep patients safe and maintain continuity in their trials.