Made possible through pilot funding and informed by user experience research, Mayo Clinic’s Clinical Trials Beyond Walls initiative leverages telehealth, remote assessments and other hospital-at-home innovations to bring all or some trial aspects into patient homes or a local community.
While decentralized clinical trials began emerging before the COVID-19 pandemic, the public health crisis accelerated the trend. For the last three years, Mayo Clinic’s Rebecca Kottschade, Dr. Tufia Haddad and Dr. Ugur Sener have been reimaging clinical trials, taking them beyond the walls of traditional research facilities.
During the HIMSS25 educational session, “Decentralizing Clinical Trials into Homes: A Case Study,” Kottschade, Mayo’s administrator of research operations, Haddad, chair of faculty development in the department of medical oncology, and Sener, a neuro-oncologist, will present their evaluation of a therapeutic intervention in patients who have received radiation therapy for brain tumors.
We interviewed the team for a preview of their session, which will highlight virtual care, remote neurological exams, in-home phlebotomy and decentralized drug distribution used in the Neuro-Oncology Anywhere clinical trial, and explain how its successes and learnings are being used to scale Mayo’s CTBW program.
Q. Since we last spoke about the clinic’s strategy for decentralized clinical trials (a presentation at HIMSS23), how has the program progressed?
A. In 2022, we set out with a bold vision: to transform clinical trials by implementing decentralized capabilities, ensuring patients could participate regardless of their geographic location. In our 2023 HIMSS presentation, we shared our strategy and foundational work to support study teams while prioritizing greater access and flexibility for trial participants.
Today, Mayo Clinic is bringing that vision to life, offering decentralized capabilities for all clinical trials. Our program has evolved from strategy to pilot implementation, and now full-scale execution, ensuring that decentralized trials are not just an option, but a standard across Mayo Clinic.
Over the past two years, we have:
- Empowered study teams and investigators with dedicated navigational support to seamlessly integrate decentralized capabilities within their research programs.
- Enhanced participant engagement through user experience research, the insights from which have informed how we connect with prospective trial participants and meet their needs.
- Developed, refined and standardized decentralized best-practice workflows by leveraging pilot studies to optimize processes, establish vendor partnerships, create self-service guides and drive adoption of decentralized capabilities.
- Advanced our data governance, architecture, technology and infrastructure to support the growing integration needs of novel wearables and sensors.
- Established programmatic data and dashboards to track the DCT portfolio, capability utilization and DCT participant characteristics.
- Simplified our end-to-end user experience for all stakeholders by building essential digital products and platforms that enable decentralized capabilities.
As we forge ahead, we envision a future in which decentralized clinical trials are not just implemented, but they are optimized, accessible and transformative to the quality and diversity of clinical trials offered at Mayo Clinic, enabling more cures to patients, anywhere.
We will continue to push the boundaries of innovation, driving a patient-first approach that makes participation in clinical research effortless, equitable and globally scalable. By reimagining the clinical trial experience, we are paving the way to accelerate discoveries and equitable delivery of breakthrough treatments, and expanding patient access to life-changing diagnostics and treatments.
Q. What is a core objective or result? Has the Mayo Clinic been able to quantify progress in clinical trial access and diversity, reducing participation burdens and/or “bringing more cures to more people”?
A. Our work is guided by four core objectives that align with our program vision to provide seamless, patient-centric and equitable decentralized clinical trials that leverage innovative solutions to improve efficiency, increase access and diversity and enable Mayo Clinic to develop and deliver more cures:
- Optimize the participant and study team experience by streamlining processes and improving usability.
- Expand access by eliminating physical, logistical and financial barriers for participants.
- Improve inclusion by making access equitable and enhancing the representation of diverse populations.
- Scale adoption by increasing the number of study teams and clinical trials that leverage decentralized capabilities.
Over the past two years, we have established key baseline metrics for decentralized capabilities utilization at Mayo Clinic and DCT participant demographics and geographic location.
Early data shows growing adoption of decentralized capabilities and greater trial participation by patients outside a 120-mile radius of a Mayo Clinic site when digital tools and remote services are included in trials.
These advancements bring us closer to a future where cutting-edge treatments reach patients faster and more equitably, transforming the way we conduct research and ultimately, deliver care.
Q. What will attendees take away from the case study presentation?
A. In this presentation, we will highlight a case study that demonstrates the real-world impact of decentralized capabilities in an oncology clinical trial – expanding patient access, improving convenience and reaching patients where they are.
Specifically, we will demonstrate how these innovations are transforming clinical trial participation for cancer patients, a population that often faces significant challenges accessing clinical trials due to the severity of their illness.
By reducing the need for in-person visits, Clinical Trials Beyond Walls is breaking down barriers and enabling more patients to contribute to and benefit from groundbreaking research. Attendees will gain insight into how decentralized approaches are not just improving trial accessibility, but also shaping the future of patient-centered clinical research.
Kottschade, Haddad and Sener’s session, “Decentralizing Clinical Trials into Homes: A Case Study,” is scheduled for Tuesday, March 4, from 3:15-4:15 p.m. at HIMSS25 in Las Vegas.
Andrea Fox is senior editor of Healthcare IT News.
Email: [email protected]
Healthcare IT News is a HIMSS Media publication.
