Digital innovation brings clinical trials to rural residents

Clinical trials advance medicine, but more than half of studies are unable to recruit or retain the necessary research participants. Digital technologies are helping make trials more accessible by moving them out of traditional research facilities.

Conventional clinical trials are conducted by staff delivering experimental treatments in a hospital or other clinical research facility. The new wave in research, known as "pragmatic trials," favors clinical trials embedded in real-world practice, adopting digital resources commonly used in patient care and applying them to virtual settings.

Technology advancements are making it possible for people to participate in clinical trials without needing to travel outside their communities — often, they can participate virtually from home. This has significant potential for increasing access to clinical trials for patients in rural communities where proximity to research facilities and the time to participate are often barriers to clinical trial participation.

A thematic review published in Mayo Clinic Proceedings by my cardiovascular colleagues in 2023 examined the effect of digital innovation on clinical trial participation and how new technologies applied beyond the clinic walls may overcome the limitations of conventional trials.

"There are a variety of digital solutions routinely used in clinical settings that are also invaluable in pragmatic clinical trials," says David Harmon Jr., M.D., a Mayo Clinic cardiology fellow. "These include electronic health records, online patient portals, and remote patient monitoring."

Understanding real-world health

One thing that's always been challenging to evaluate in clinical trials is how a treatment may work in everyday life outside a hospital or clinic. Digital tools make that possible by providing a "digital window" into real-world health and ensuring studies reflect the unique needs of participants from underserved areas, including rural communities.

The average person may already have everything they need to participate in a clinical trial in the palm of their hand or strapped to their wrist. The researchers note that 85 percent of U.S. citizens own a smartphone, and 20 percent own a smartwatch or other wearable technology. Using these tools, people can participate in many clinical trial activities remotely — from enrolling in and consenting to a study to gathering and submitting study data — without traveling to a research facility or interrupting their daily lives.

When necessary, researchers may also provide study-owned devices for participants to use and coordinate convenient ways for people to participate by visiting local health clinics, libraries, or other community locations. These tactics help overcome barriers that might prevent people from participating in a trial.

"Our goal is to address health questions that are important to patients and their communities and questions that are critical for clinicians and health systems to inform their decision-making," says Peter Noseworthy, M.D., a cardiologist and former medical director of Mayo Clinic Cardiac Monitoring. "When possible, people should be allowed to participate in research within their own environment, at times convenient to them, and in ways that require minimal additional burden."

Recognizing the limits

My colleagues who authored the study acknowledge the limitations of using digital technology in clinical trials. For example, reliance on technology may create bias and barriers for people who are underrepresented in research. The researchers cite a smartwatch-enabled heart health study in which reliance on participant-owned devices resulted in recruiting disproportionately younger, more tech-savvy participants who, due to their age, were less likely to have heart disease.

Pragmatic study designs, while intended to be less disruptive to participants, also may be so "hands off" that they result in shifting the labor of data collection from study staff to participants. A lack of in-person follow-up may leave participants wondering how to act on their study results.

Embracing choice and flexibility

While pragmatic design and digital innovation help scientists understand the clinical impact and real-world effectiveness of clinical trials, it's not a one-size-fits-all approach.

Hybrid trials combine elements of conventional design, such as in-person assessment, with digital elements, such as a mobile app for data collection. This flexibility can also be built into trials, allowing participants choices in how they interact with study staff or complete study requirements.

This approach creates options for more inclusive participation, according to Xiaoxi Yao, Ph.D., the Robert D. and Patricia E. Kern Scientific Director for Pragmatic Trials and Evaluation in the Mayo Clinic Kern Center for the Science of Health Care Delivery.

"These digital solutions have enabled scientists to enhance inclusivity in clinical trials at all levels, from the research topics chosen to the geographic regions where research is conducted to the background of the people leading and participating in studies," Yao says. "This creates a more robust learning health system that aims to generate evidence and cures meaningful to all people."

NRHA adapted the above piece from Mayo Clinic, a trusted NRHA partner, for publication within the Association’s Rural Health Voices blog.

About the author: Abhishek Deshmukh, M.B.B.S., is a Mayo Clinic cardiologist and researcher with a focus on using large datasets to examine quality, outcomes, and risk prediction for heart rhythm disorders. He also serves as medical director for Mayo Clinic Cardiac Monitoring, which enables access to one of the world’s premier cardiovascular practices through remote cardiac monitoring services.