ROCHESTER, Minn., July 20: A Mayo Clinic study published in JAMA Network Open found that bringing some or all clinical trial-related activities directly to patients can help overcome barriers that prevent many people from participating. Increased participation and expanded access to research was observed for people in rural communities and underserved populations.
The study evaluated Mayo Clinic’s decentralized clinical trials program, which allows many research activities to take place outside a traditional research site through services such as remote informed consent, video visits, in-home blood draws, remote monitoring and home delivery of oral study medications. Researchers found the approach expanded the geographic reach of clinical trials while increasing participation among patients who have historically faced barriers to enrollment.
Broader participation can help ensure clinical trial findings better reflect the patients who will ultimately receive new treatments.
“Clinical trials shape the future of medicine,” says Tufia Haddad, M.D., a medical oncologist at Mayo Clinic Comprehensive Cancer Center in Rochester and the study’s first author. “When we put those trial results into clinical practice, we need to make sure they’re representative of all the patients we see.”
Researchers evaluated 765 clinical trials involving 7,469 participants over 15 months. The percentage of participants living more than 120 miles from a Mayo Clinic campus in Rochester, Minnesota; Phoenix; or Jacksonville, Florida, increased from 18.9% to 29.6%. Enrollment from rural communities increased from 16.6% to 24.9%, while participation among underserved racial and ethnic populations increased from 12.5% to 17.4%.
“We showed that decentralized clinical trial infrastructure can make research access measurable,” says Lydia Mercado, M.D., senior research program coordinator at Mayo Clinic in Florida and the study’s second author. “By reducing travel requirements and other logistical burdens, we create more realistic opportunities for patients to participate in research.”
Bringing research closer to patients
Only a small percentage of patients who are eligible for clinical trials ultimately enroll. In addition to limited awareness of research opportunities, participation often requires frequent visits for physical exams, laboratory testing and safety monitoring – creating significant time and travel burdens for patients and caregivers.
Depending on the study, decentralized clinical trials allow many of those activities to take place closer to where patients live. Participants may review and sign consent forms electronically, meet with research teams through secure video visits, receive in-home blood draws, have oral study medications delivered to their homes, and use wearable devices or other digital tools to monitor their health between visits.
“The most innovative clinical trials are often conducted at academic medical centers, while the majority of healthcare is delivered in community settings,” Dr. Haddad says. “We don’t want a patient’s ZIP code or geography to determine whether they can access these research opportunities.”
Researchers emphasize that decentralized approaches do not replace traditional clinical trials but instead move only those activities that can be safely conducted outside a research center. Institutional review boards carefully evaluate study protocols, and research teams determine which assessments can occur remotely while maintaining patient safety and study quality.
Expanding access while maintaining research quality
Researchers also intentionally tracked participation among rural and historically underserved populations to evaluate whether decentralized clinical trials expanded access more equitably.
“We didn’t want these decentralized capabilities to widen existing gaps in research participation, but rather our goal was to help close them,” Dr. Haddad says. “From the program’s inception, we intentionally focused on these metrics.”
To help remove technology barriers, the program provides cellular-enabled tablets when needed, selects technologies with demonstrated ease of use, offers technical support and, when appropriate, gives participants options for how they engage with study teams.
“Flexibility is one of the greatest advantages of decentralized clinical trials,” Dr. Mercado says. “Studies can be designed around the patient while still meeting scientific objectives.”
Shaping the future of clinical trials
The findings support Mayo Clinic’s broader Clinical Trials Beyond Walls program, which aims to make research available to all communities.
“Think of what this means for patients who are going through a cancer diagnosis,” says Cheryl Willman, M.D., co-author of the study and the Stephen and Barbara Slaggie Executive Director, Mayo Clinic Cancer Programs, and director, Mayo Clinic Comprehensive Cancer Center. Cancer clinical trials are the most common trials at Mayo Clinic that are leveraging decentralized capabilities – 58% of the trials in the study were cancer-related. “Patients are getting access to cutting-edge therapies from the most trusted name in healthcare, all in the healing environment of your home.”
The next phase of decentralized trials will focus on expanding collaborations with community healthcare providers so more study activities can be completed closer to patients’ homes.
Researchers expect continued advances in mobile diagnostics, remote imaging, digital health technologies and at-home drug treatments that could further reduce the need for travel while maintaining rigorous clinical research.
This work is also part of the Clinical Impact initiative at Mayo Clinic, which aims to bring the promise of clinical trials to more patients, ensuring that they gain access to new therapies as quickly as possible.
“We’re already enrolling patients who have never stepped foot in a Mayo Clinic facility,” Dr. Haddad says. “The long-term goal is to build an infrastructure that not only serves Mayo Clinic patients but can ultimately help other research organizations reach more patients, regardless of where they live.