How a Pandemic Accelerated the Adoption of Virtual Trials

Jonathan Cotliar
Science 37
Clinical trial operations worldwide have slowed dramatically during the COVID-19 era, but the adoption of virtual trials has accelerated. A virtual trial doctor explores the transformation.
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ike many others, I’ve spent the last four years trying to convince the biopharmaceutical industry that virtual or decentralized trials are the future of drug development. And that, if executed correctly, virtual trials maintain the same level of patient safety and high-quality data that are the cornerstones of traditional, site-based research. Society has arrived at a point at which the powerful mobile device we carry in our pocket—that we use to do everything from ordering our morning cup of coffee to buying a house—can be the tool that dismantles several of the barriers that have historically plagued clinical research.

For participants to remain in a trial, they are often required to travel to research sites hours away from where they live, take time off from work, and find care for children and other dependents. Technology can offer a better solution by allowing us to create a paradigm where the patient is at the center of the research experience, and not a prisoner to it. A decentralized clinical trial platform, run from a mobile device, can enable and coordinate all of the study-related procedures and assessments that have historically taken place at a clinic or hospital, and shift those activities into the living room of any eligible individual who wants to enroll in a trial. Combining this technology with a network of doctors, nurses, research coordinators, and data managers is making this paradigm a reality over the course of the many virtual trials that have been conducted so far.

Market adoption of virtual trials has been steady and gradual over the past five years. Still, for every sponsor that yearns to innovate and performs virtual trials, there are numerous others that opt not to pursue a path of virtualization. In many cases, it is about risk aversion. Along with the time and cost associated with successfully bringing a molecule to the marketplace, there is a highly complex regulatory process, both in the US and beyond, that does not yet have codified guidance that industry stakeholders can rely on to better understand the operational feasibility of running virtual trials. Thus, organizations with a desire to innovate are largely left to rely on the interpretation of local laws (at the state level in the US, and at the national level in the European Union and globally) as well as guidance documents created to govern the traditional research model. Then COVID-19 came along.

The Impact of COVID-19

A number of people have spent years trying to convince pharmaceutical executives, clinical development teams, physicians, regulatory authorities, and other stakeholders in our industry that virtual trials can provide a more efficient path to drug development—often only to be met with great skepticism. The COVID-19 pandemic is now rapidly impacting the clinical trial landscape; those who were once skeptical of the virtual model are now compelled to embrace it out of necessity. We are now seeing exponential growth in the adoption of virtual trials as sponsors struggle to keep their global trials running; the brick-and-mortar sites previously conducting these trials are being forced to close their doors to prioritize care for those infected with the coronavirus and to minimize the risk of others being infected, such as patients seeking routine medical care, clinical trial participants, and healthcare workers.

In a span of five days in late March, both the Food and Drug Administration and the European Medicines Agency published guidance documents that called out the use of telemedicine and virtual visits as vital tools to ensure safety for patients already enrolled in clinical trials, and as a mechanism by which drug development continuity could be provided. Since that time, in discussions about risk mitigation for ongoing trials, many sponsors are pivoting with their protocols and now seeking to minimize in-person interactions for patients, employ telemedicine where possible, and have investigational medicines and other study supplies shipped directly to patients. These are elements that a robust virtual model already provides.

At a time when two million people globally have been infected with COVID-19, more than 125,000 people have perished from the virus, and entire industries have been crippled by the economic fallout of worldwide social distancing, virtual trials put patients first while still providing sponsors with some degree of continuity.

Conclusion

The COVID-19 pandemic is transforming how the industry thinks about clinical trial execution. If research can be made more convenient for participants via a virtual model while simultaneously mitigating some of the risks associated with the pandemic, virtual trials are a logical approach. This shift can also help reduce the burden on healthcare systems and personnel that may be dealing with extraordinarily difficult circumstances due to the crisis.

It would have been preferable that the catalyst for the market adoption of virtual trials be something other than a pandemic that has so tragically affected so many people—those who have died, those who have lost their jobs, and the friends and family of those who have suffered. I take solace in our industry’s ability to problem solve.

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