Since Pfizer launched the first randomized clinical trial to be conducted entirely remotely in 2011, virtual clinical trials have been a trend waiting to happen. Now, prompted by the COVID-19 pandemic, and given the blessing of the FDA, broad acceptance of decentralized trials is becoming a reality.
Writing in the May DIA Global Forum, Dr. Jonathan Cotliar, says that with the impact COVID-19 is having on traditional, face-to-face trials, “Those who were once skeptical of the virtual model are now compelled to embrace it out of necessity.”
As chief medical officer of the virtual clinical trial management company Science 37, Cotliar would be expected to say that. But he’s not alone. Since the beginning of the year, interest in virtual clinical trials has grown; dozens of articles extolling their benefits and predicting their broader adoption have been published.
After the Food and Drug Administration released its “Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” in March, interest in decentralized trials has soared.
The Guidance says that for trials already underway, “Sponsors should determine if in-person visits are necessary to fully assure the safety of trial participants.” The FDA says “sponsors should evaluate whether alternative methods” – among them, virtual visits and phone contact – would be adequate substitutes for in-person contact.
Discussing the FDA guidance, Clinical Leader chief editor Ed Miseta, wrote, “With patients concerned for their health and hesitant about leaving their homes or visiting clinics or hospitals, incorporating virtual aspects into trials may be the only way to ensure their continued participation.”
The clinical news and information portal HCPLive, published a perspective in April pointing out, “The ongoing advancements in cloud, mobile, and IoT, combined with video conferencing and wearables, are opening up unprecedented opportunities for pharma and healthcare, bringing about the evolution of clinical trial management.”
Those technologies writes Daniel Piekarz SVP of Life Sciences & Healthcare at the software development firm, DataArt, will make virtual clinical trials and digital healthcare the “new normal post-COVID-19.”
There are significant benefits to both patients and trial sponsors and managers of virtual trials versus conventional, centralized trials. As Piekarz explains, “Virtual visits and remote patient monitoring in place of mandated in-person site visits gives trial participants a choice as well as the added peace of mind that they won’t be exposed to unnecessary risks. Virtual visits allow sponsors to reach a larger population of participants improving subject recruitment, engagement, and retention.”
Indeed, last month, the managed care company UnitedHealth Group and Yale School of Medicine said they would be launching a virtual study examining the potential role of ACE inhibitors in preventing the severe consequences of COVID-19. The study “Will adopt an innovative, modern approach as one of the first virtual COVID-19 clinical trials to be launched at scale with a suite of digital tools.”
And just last week Reuters reported that LabCorp and software provider Medable will work together “to speed up the adoption of virtual clinical trials, as many participants are dropping out of ongoing studies due to the COVID-19 pandemic.”