By: Alexander W. Pastuszak, MD, PhD, President of Clinical Care and Chief Clinical Officer at Vault Health
It’s an established fact that the future of clinical research lies in the ability to replace many in-person clinical trial activities with digital tools. Even before the COVID-19 pandemic, researchers promoted the many benefits of decentralized clinical trials (DCTs), including speed, efficiency, cost, and patient recruitment.
Studies show that trials are lengthy endeavors with low completion rates—roughly two-thirds of trials are terminated for reasons other than reaching their endpoints and more than half are halted due to insufficient patient recruitment.1
Yet the range of digital tools now available mean that many—or even all—of those site-based in-person clinical trial activities can be replaced with protocols using telemedicine, remote patient monitoring tools, mobile/local healthcare providers, and other technologies.
Paired with this advanced resource capability is an increasing patient desire for participation in clinical trials, especially if trials are virtual or take place at retail clinics rather than if they require more than 30 minutes of travel or going to a hospital.2
The number of patients interested in using telehealth has skyrocketed: 76% of patients in 2020 were interested in using telehealth for care, compared to 11% in 2019.3 And more than half of U.S. adults are interested in fully virtual clinical trial visits, such as through an app.4
Even with the tools and interest, researchers must take deliberate and thoughtful steps to ensure that within a decentralized or hybrid environment they build and maintain the human connections necessary to develop new and innovative therapies.
Vault’s history of and success in providing clinical care and telehealth services directly to patients, combined with our technology-enabled clinical research capabilities as a decentralized research organization (DRO) presents an optimistic future for the industry where new therapies can be brought to market faster, through a simple, efficient, and integrated model with the patient at the center.
Truly putting the patient at the center intrinsically builds human connections and results in more engagement, and there are a few key steps in accomplishing this.
The first step is representation.
Many people in communities that are historically underrepresented in clinical trials are often resistant to participating in clinical trials because of historic mistreatment. Infamous studies like the Tuskegee Syphilis Study and modern discriminations in healthcare, such as limited access to health insurance and specialty care, have continued to alienate marginalized communities.
Any clinical practice must demonstrate the full range of cultural diversity that it seeks to study. That doesn’t just mean having a diverse group of practitioners. It means having those practitioners in leadership roles, parity in decision-making, and seeing those values practiced day in and day out.
Respected patient networks that engage patients using widely adopted technology will broaden trial access to marginalized communities and improve recruitment by reducing the burden and expenses to patients related to travel, accommodation, childcare, mobility, or missed workdays.
Vault’s established clinical practice, partnership networks, and logistics and data management capabilities enable us to quickly align eligible patients with clinical trials they can participate in, and recruit them via online outreach and/or in person at their homes, rather than requiring them to visit a physical clinical trial site. These hybrid protocols enhance diversity across clinical trial populations and shorten recruitment and enrollment time.
The second step to patient centricity is health and tech literacy.
People of all backgrounds vary in their familiarity with or access to digital tools, as well as a solid grasp of understanding and using health-related information and services. Too often this lack of health and tech literacy are communicated as concerns by trial participants. Researchers must start by validating a participant’s concerns, not dismissing them—then, sharing information in a respectful way.
In these conversations, language choice matters.
Participating in a clinical trial requires consent, and using clear language reinforcing that one doesn’t give up their agency or humanity by being part of a clinical trial is critical.
Beyond language choice, patient-centered trial design is critical to supporting and enhancing tech literacy. These barriers can be mitigated with user-friendly interfaces, online patient training and support, plain language in patient communications, integrations with other platforms, and options to choose virtual, hybrid, or in-person assessments, as examples. Vault offers API-driven services through its clinical trial operating system to help ensure seamless experiences for CROs, investigators, and patients.
Our hybrid approach can improve patient engagement and retention, study efficiency, data acquisition, and can ultimately improve study outcomes. We give researchers and healthcare professionals the ability to monitor progress and connect on an ongoing basis at the patient’s convenience, rather than only during onsite visits—helping paint a more accurate picture of participants’ health information throughout the trial and minimizing the incidence of missed data points or safety issues.
By removing burdensome barriers typically encountered with physical site-based trials through easy-to-use technology and accessible communication methods, the patient experience is simplified, helping lead to better retention and engagement, and ultimately shorter trial cycles for critical therapies.
1 Rebecca J Williams, Tony Tse, DiPiazza K, Zarin DA (2015). Terminated Trials in the ClinicalTrials.gov Results Database: Evaluation of Availability of Primary Outcome Data and Reasons for Termination. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0127242
2 Gaby Galvin (2021). Clinical Trials Are Slow and Expensive. Industry Leaders Want That to Change in 2022. https://morningconsult.com/2021/12/21/clinical-trials-poll-2022/
3 Oleg Bestsennyy, Greg Gilbert, Alex Harris, Jennifer Rost (2020). Telehealth: A quarter-trillion-dollar post-COVID-19 reality? https://www.mckinsey.com/~/media/McKinsey/Industries/Healthcare%20Systems%20and%20Services/Our%20Insights/Telehealth%20A%20quarter%20trillion%20dollar%20post%20COVID%2019%20reality/Telehealth-A-quarter-trilliondollar-post-COVID-19-reality.pdf