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A patient takes their own blood pressure, as they would do when reporting biometrics for a remote clinical trial.

The Disruption Series: Post-Pandemic Virtual Clinical Trials

How the research space could change after COVID-19


This is the fourth piece in the Lionbridge Disruption Series, a collection of commentary from life sciences experts on how the industry is changing as a result of the COVID-19 crisis.

Will virtual clinical trials become the new normal in the wake of COVID-19?

The COVID-19 pandemic has introduced historically unseen roadblocks into clinical trial conduct as we know it, and is presenting unprecedented challenges  to the entire clinical research and healthcare ecosystem. Clinical trials that started before the pandemic are being modified, delayed or shutdown in large numbers while the research community and regulators are rushing to launch clinical trials for potential new COVID-19 treatments.

Disruption is occurring everywhere. It’s visible in the race to create and deliver tests, develop a new vaccine for the novel coronavirus, and the acceleration of related trials. It’s visible in healthcare systems stretched to the max providing emergency care for COVID-19 patients. And it’s visible in the thousands of clinical trials addressing other life-threatening, rare or chronic diseases.

Many trial sponsors are reducing the impact of COVID-19 on planned protocol procedures with the help of digital technologies and as a result, have begun to see the many benefits of virtual or remote trials. Recently, both the FDA and the EMA relaxed regulations and encouraged trial sponsors to take advantage of that technology that doesn’t impact patient safety.

From small steps to leaps forward in the virtual landscape

Crises are rare periods of history when need accelerates the timeline for testing theories and lowers the barrier to start experimenting. We all need to adapt at an extreme pace these days to maintain whatever normalcy is possible.

In clinical trials as well as in routine clinical settings, patients and practitioners are witnessing an explosive uptake of telehealth technologies, online training platforms and remote data capture. Onsite clinic visits are replaced by remote consultations over video or phone or by a mobile nurse solution. Patients receive laboratory test kits at home along with video instructions or remote consultations to perform the test and then upload the data via digital and mobile tools. In clinics, QR codes offer a non-touch solution to access information easily and without risk of infection. On March 23, the National Institutes of Health (NIH) announced the launch of a website for virtual safety training for coronavirus frontline workers.

The pharma industry is often accused of being a slow adopter of technology due to concerns over data integrity, patient safety and maybe even a cultivated skepticism. But in the current crisis situation, technology can literally mean the difference between life and death. Clinics are overwhelmed, patients are reluctant or afraid to attend onsite visits, and there is a critical lack of personal protective equipment for providers. Technology has the power to alleviate some of those obstacles while we practice social distancing. This pandemic brings new light to how digital solutions can aid or augment clinical research.

Post-pandemic value of virtual or site-less trials

While the pandemic has shown the value of adopting technology solutions for purposes of urgent mitigation or contingency, the prospect of virtual or hybrid trials applies to a post-pandemic world as well. The current execution model for clinical trials is anchored in the clinical site and regular onsite visits for patients and monitors. Many of these activities can be replaced or augmented with mobile technologies such as tablets, wearables, smartphones or telehealth solutions. In addition, training of site and sponsor staff can be executed remotely via eLearning, augmented reality, by use of real-time translations or over-the-phone interpretation. A multinational investigator meeting can be carried out online without delaying trial startup and at much lower travel costs. Another value-add is that digital content can be easily changed, accessed and localized to match the language or information needs of the audience.

The extent to which a trial can transition to virtual environments depends on the trial design. There’s no ”one size fits all” within clinical research. The concept of a fully site-less trial is unlikely to manifest in the foreseeable future. It would require much greater regulatory direction, even though both the FDA and EMA have already expressed their support.

Increasing use of technology to reduce site visits

A more probable solution in the coming years is an uptick in the blended trial design that uses a hybrid model of onsite and remote trial procedures. Technology can help relieve burdens of trial participation. It allows sponsors to reach patient populations in remote areas, speed up recruitment and increase patient retention. Mobile health devices (e.g. ePROs, eDiaries or eConsent) can capture data directly from patients. All of these measures can contribute to a better patient experience.

Rolling out these technology based-trial experiences can be difficult for anyone in the clinical space right now. That’s why partnering with a team experienced in life sciences is critical to surviving the current disruptions. Lionbridge has the knowledge and resources to help communicate at every step of the clinical trial process from training site staff to translating results when a device or medication is ready to hit the shelves. Reach out to our team across the globe for more on how we can support your team.

 

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Pia Windelov
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Pia Windelov