On July 20, 2026, Mayo Clinic reported peer-reviewed evidence that decentralization changes who takes part in clinical research. In a study published in JAMA Network Open, investigators evaluated Mayo's decentralized clinical trials program across campuses in Rochester, Phoenix, and Jacksonville, covering 765 trials and 7,469 participants over 15 months.
Over that period, participation by patients living more than 120 miles from a Mayo campus rose from 18.9% to 29.6%. Enrollment from rural communities rose from 16.6% to 24.9%, and participation among underserved racial and ethnic populations rose from 12.5% to 17.4%. The program used remote electronic informed consent, secure video visits, in-home blood draws, remote monitoring with wearables, and home delivery of oral study medication. To lower technology barriers, teams provided cellular-enabled tablets and technical support where participants needed them.
Interestingly, decentralized approaches did not replace all the aspects of a traditional trial. Instead, institutional review boards evaluated each protocol, and study teams decided which assessments could safely happen remotely while maintaining data quality. As Dr. Haddad framed it, "We don't want a patient's ZIP code or geography to determine whether they can access these research opportunities." Cancer trials made up 58% of the studies evaluated, though the program and its findings apply across therapeutic areas rather than to oncology alone.
The Mayo result lands on established regulatory footing. The FDA's final guidance, Conducting Clinical Trials With Decentralized Elements, sets out how sponsors and investigators can implement remote consent, local sampling, and telehealth visits within existing quality expectations. The Mayo program is a working example of those recommendations applied across a large trial portfolio.
The FDA's June 2024 draft guidance on Diversity Action Plans asked sponsors to plan and measure enrollment from underrepresented populations, and to set concrete enrollment goals. That guidance sets the expectation; the Mayo data shows one mechanism that moves the underlying metrics. Read together, the two documents reframe decentralization from an operational convenience into a measurable access intervention, where the way a trial collects data shapes who is able to participate.
The Mayo findings come from a single large academic system with three campuses and considerable infrastructure. The open question is whether the same access gains hold when decentralized elements reach community healthcare providers and smaller sponsors that lack that infrastructure, which is the focus of Mayo's next phase.
Two developments are worth following. The first is whether decentralized methods can be standardized enough for community providers and mid-sized sponsors to adopt without rebuilding operations for each study. The second is whether the diversity gains reported at Mayo reproduce across therapeutic areas and study designs, and whether sponsors report them against the diversity metrics the FDA guidance now expects.
For rare disease and precision medicine, the implication is more specific. As eligibility becomes narrower and more genetically defined, decentralized recruitment and at-home testing move from useful to necessary, because the eligible population is rarely concentrated near any one site. Teams designing these studies can treat data-collection location as a variable they set deliberately, then measure the access it produces.
To discuss how Sano can support genotype-first recruitment and at-home genetic testing, get in touch.