Long before the global pandemic, clinical trial sponsors were consumed with accelerating their studies and improving the trial experience for key stakeholders. Decentralization emerged as a leading factor in this pursuit. As COVID-19 inundated healthcare facilities and disrupted clinical research, it also catalyzed the adoption of decentralized solutions.
When health resources shifted priorities to COVID-19-related needs, patients’ trial site access reduced by 80 percent and trial starts declined by 50 percent between January and April 2020.1 As a result, the industry was forced to adopt decentralized solutions to address growing challenges with remote trial activities and engaging with dispersed patients.
Although the pandemic isn’t behind us yet, trends are suggesting that decentralized trials are here to stay. One survey found that 98 percent of trial participants were satisfied with telemedicine.2 And 72 percent of physicians reported similar or better experiences using remote engagement tools compared to in-clinic visits.
The response from the industry suggests that decentralization is not a fleeting fad. But what does the future of decentralized clinical trials look like? We will explore emerging trends resulting from decentralized trials during COVID-19 and what they suggest about the future of DCT.
Social distancing and mandated stay-at-home orders had a big impact on society’s relationship with technology. Traditional workplaces transitioned to remote environments and leveraged communication and collaboration tools to connect dispersed teams. Fitness wearables boomed as companies like Apple, Peloton, and Strava made it easy to monitor your health anywhere. Remote telehealth visits for primary care physicians and mental health specialists became commonplace.
As a result, physician and patient comfort with remote technologies grew significantly during 2020.1 At the height of the pandemic, physicians reported using remote technologies for nearly 80 percent of sponsor and 57 percent of patient interactions.1 Experts believe that as comfort levels continue to grow, the clinical trial industry will experience a threefold increase in remote patient interactions after the pandemic.
As decentralized tools for remote data collection mature—including camera, voice, touch, video, actigraphy, sensors, eCOA, and more—they are also being increasingly validated. These pre-validated technologies are helping encourage broader use across the industry.
Similarly, regulatory acceptance prompted by the pandemic has led to new guidance permitting the use of decentralized clinical trial technologies. These include remote monitoring, direct-to-patient IP shipments, hybrid and virtual trial sites, telehealth, and more. As acceptance and adoption become more mainstream, experts anticipate this trend will carry on long after the pandemic. A 2021 report found that 80% of sites and 83% of sponsors plan to conduct all or most of their monitoring visits remotely by 2023.3
The clinical trial industry initially pivoted towards decentralized trials as a temporary measure against COVID-19. But as a greater number of trials implemented hybrid and virtual studies, it became clear the impact it can have on patient recruitment, retention, and adherence.
Decentralized technologies accelerate and aid patient recruitment by widening the pool of potential patients. Removing physical barriers from clinical research allows trials to better engage with patients living in remote areas or underserved communities, who would historically be excluded from participating. They also enable better patient diversity by creating a wider pool of participants instead of limiting it to those living closest to the trial site and reducing barriers that predominantly impact minority communities. Once patients are enrolled, there is evidence that decentralized eConsent and eCOA forms help patients become more knowledgeable, informed, and engaged in their trial experience.4
Study managers benefit from decentralized technologies by gathering more diverse and applicable data that aids result in meaningful study outcomes. As patients and physicians realize the impact of decentralized technologies on patient-centricity, their expectations are changing. Patients want to feel like active participants in their care and decentralization is giving them the autonomy to do that.
In June of last year, the FDA announced its COVID-19 Diagnostics Evidence Accelerator that used real-world evidence (RWE) to inform the agency’s response, drive collaboration, and accelerate timelines.5 This prompted an even greater emphasis on the industry to move towards evidence-based decisions to drive better patient outcomes while keeping studies on time and on budget.
In a 2020 Deloitte report, 80% of organizations said they were actively working on increasing access to real-world data sources.5 Decentralized solutions that support remote data collection and sharing across dispersed teams are helping to accelerate this trend. The data generated is helping researchers better understand the burden of diseases, how to monitor patients’ safety, and streamline processes. In fact, a recent study leveraging decentralized RWE was able to reduce their sample size for phase III studies by 40%.5
Experts anticipate that RWE will evolve to support more nuanced cases like regulatory submissions, informing value-based contracts, and building synthetic control arms. Until that point, 94% of organizations say RWE will be important or very important to their organization moving forward.
As decentralized technologies evolve, it will be interesting to see how they continue to support and streamline manual clinical trial processes. The pandemic propelled the industry toward digitalization and the world is watching to see how that impacts clinical research moving forward. As sponsors and CROs look to embrace decentralized solutions, it’s imperative that they carefully consider which technologies will help them scale and grow for the future.
Medrio has been helping sponsors and CROs decentralize their studies long before COVID-19. Let us help you embrace decentralization through flexible, scalable workflows that support traditional, hybrid, and virtual trials. Spend less time managing vendors and more time on your patients by embracing decentralization today.