The Mayo Clinic’s Clinical Trials Beyond Walls (CTBW) initiative is transforming the landscape of clinical research by leveraging telehealth, remote assessments, and hospital-at-home innovations. This groundbreaking approach aims to decentralize clinical trials, integrating various trial aspects into patient homes or local communities. The initiative is a significant milestone in patient-centered clinical research, enhancing accessibility, diversity, and efficiency.
The Rise of Decentralized Clinical Trials
Accelerated by the COVID-19 Pandemic
Decentralized clinical trials were gaining traction even before the COVID-19 pandemic, but the health crisis significantly accelerated this trend. Over the past three years, Mayo Clinic’s Rebecca Kottschade, Dr. Tufia Haddad, and Dr. Ugur Sener have been at the forefront of reimagining and extending clinical trials beyond traditional research facilities. Their efforts are highlighted in an educational session at HIMSS25 titled “Decentralizing Clinical Trials into Homes: A Case Study.” The session delves into the project’s progress, showcasing virtual care, remote neurological exams, in-home phlebotomy, and decentralized drug distribution used in a neuro-oncology trial.
Key Innovations in Decentralized Trials
Some notable strides include the use of advanced telehealth services permitting virtual evaluations and check-ins, thus diminishing the constraint for physical visits to clinical sites. Meanwhile, remote neurological exams enable professionals to monitor and assess neurological health without requiring direct physical presence, maintaining precision and patient comfort. In-home phlebotomy services involve drawing blood from patients in their homes, streamlining the process and making participation more convenient for those who might find traveling to a clinic challenging. Big strides have also been made in decentralizing drug distribution, with medications being delivered directly to patients’ homes, ensuring consistent and timely access to necessary treatments. These innovations make participation in clinical trials more accessible, particularly for those in underserved or remote areas.
Transforming Vision into Reality
Building Core Infrastructure
Since presenting their strategy for decentralized clinical trials at HIMSS23, Mayo Clinic has made significant strides in transforming their vision into reality. The development of a core infrastructure that supports the execution of decentralized trials as a standard practice across Mayo Clinic has been a pivotal achievement. This infrastructure ensures that patients can participate in clinical trials irrespective of their geographic location. A proactive approach was adopted to establish an efficient, technological framework that aptly incorporates telehealth, remote data collection, and communication technologies, ensuring trials remain comprehensive and seamless.
Empowering Study Teams and Investigators
The team has empowered study teams and investigators by offering dedicated navigational support to integrate these decentralized capabilities seamlessly within their research programs. User experience research insights have been utilized to enhance participant engagement, allowing for more effective connections with prospective trial participants and catering to their needs. The initiative focuses on meticulous training of study teams to ensure they are well-equipped with the nuances of managing decentralized trials. This approach includes creating intuitive platforms for communication and data management, ensuring seamless experiences for both researchers and participants while fostering a supportive research environment.
Enhancing Participant Engagement
Development and Standardization of Workflows
The development, refinement, and standardization of best-practice workflows for decentralized trials have been crucial. This included leveraging pilot studies to optimize processes, establishing vendor partnerships, creating self-service guides, and driving the adoption of decentralized capabilities. These efforts ensure that the trial processes are streamlined and user-friendly for all stakeholders involved. By standardizing these workflows, Mayo Clinic ensures consistency and reliability across various studies, thereby enhancing the overall efficiency and effectiveness of clinical trials.
Integration of Wearable Devices and Sensors
To support the novel integration needs of wearable devices and sensors, Mayo Clinic has advanced its data governance, architecture, technology, and infrastructure. The establishment of programmatic data and dashboards allows them to track the DCT portfolio, capability utilization, and participant characteristics efficiently. Simplifying the end-to-end user experience for all stakeholders has also been prioritized by developing essential digital products and platforms that enable decentralized capabilities. Wearable devices are pivotal in providing continuous, real-time health data, reducing the need for frequent in-person assessments, and offering a broader, more comprehensive understanding of the patient’s condition and progression during the trial.
Core Objectives of the CTBW Initiative
Optimizing Participant and Study Team Experience
Four core objectives guide their endeavor: optimizing the participant and study team experience by streamlining processes and enhancing usability. This objective ensures that both participants and study teams have a seamless and efficient experience throughout the trial process. Achieving this requires an emphasis on user-friendly interfaces, reliable communication channels, and efficient data management systems that reduce the administrative burden on study teams, thereby allowing them to focus more on patient care and research integrity.
Expanding Access and Improving Inclusion
Expanding access by eliminating physical, logistical, and financial barriers for participants is another key objective. This is complemented by improving inclusion, making access equitable, and enhancing the representation of diverse populations. These objectives are crucial in ensuring that clinical trials are accessible to a broader and more diverse group of participants. By embracing decentralized approaches, Mayo Clinic aspires to bridge the gap often experienced by underrepresented communities, thus fostering an environment where diverse populations contribute to and benefit from cutting-edge medical research.
Scaling Adoption of Decentralized Capabilities
Scaling adoption by increasing the number of study teams and clinical trials utilizing decentralized capabilities is the final core objective. Mayo Clinic has tracked key baseline metrics regarding the utilization of decentralized capabilities and the demographics and geographic locations of DCT participants over the past two years. Early data indicates growing adoption of these capabilities and increased participation by patients residing beyond a 120-mile radius of a Mayo Clinic site. The promising statistics underpin the favorable reception and impact of these innovations, signifying a transformative shift in how clinical trials are conducted.
Real-World Impact of Decentralized Capabilities
Case Study from an Oncology Clinical Trial
In their upcoming HIMSS25 presentation, Kottschade, Haddad, and Sener will present a case study from an oncology clinical trial. The trial focuses on a therapeutic intervention for patients who have undergone radiation therapy for brain tumors. This case study demonstrates how decentralized capabilities have expanded patient access, enhanced convenience, and allowed patients to participate in groundbreaking research from their homes. The success of this trial is a testament to the viability and efficiency of decentralized trials, particularly for patients with severe medical conditions.
Significance for Cancer Patients
This is particularly significant for cancer patients who often face severe challenges accessing clinical trials due to their illness. The initiative, Clinical Trials Beyond Walls, reduces the need for in-person visits, breaking down barriers and enabling a larger pool of patients to contribute to and benefit from pioneering research. By bringing trials to patients’ doorsteps, it not only alleviates the physical and emotional strain but also ensures continuous engagement and adherence to the trial protocols. The results from these trials could lead to life-changing treatments and improve the overall quality of life for cancer patients, providing hope to many who previously found it inconceivable to participate in such intensive research programs.
Shaping the Future of Patient-Centered Clinical Research
Transforming Clinical Trial Participation
The Mayo Clinic’s Clinical Trials Beyond Walls (CTBW) initiative is revolutionizing clinical research by harnessing the power of telehealth, remote assessments, and hospital-at-home advancements. This innovative approach is designed to decentralize clinical trials, effectively integrating trial components into patients’ homes or nearby communities. By doing so, CTBW is setting a new standard in patient-centered clinical research.
This initiative is a significant step forward, as it greatly enhances the accessibility of clinical trials, making it easier for a diverse patient population to participate. It also boosts the efficiency of these trials by reducing the need for patients to travel long distances to central trial sites. Instead, patients can receive care and undergo assessments right in their own homes.
Moreover, this model fosters inclusivity, ensuring that a wider demographic can benefit from participating in clinical trials. The CTBW is a promising development that not only addresses logistical challenges but also brings clinical research closer to the community, making it more patient-friendly and effective.
