Mayo Clinic has embarked on a groundbreaking journey to revolutionize clinical trials by integrating advanced technologies. This forward-thinking initiative, aptly named Clinical Trials Beyond Walls (CTBW), aims to decentralize clinical trials, making them more accessible, patient-centric, and efficient. By leveraging telehealth, remote assessments, and cutting-edge innovations, Mayo Clinic is extending clinical trials beyond the confines of traditional research facilities to reach patients in their homes and local communities. The COVID-19 pandemic significantly accelerated this transformation by underscoring the need for flexible, accessible clinical trial models that can adapt to global health challenges.
The Vision Behind Clinical Trials Beyond Walls
In 2022, Mayo Clinic laid out a bold vision to transform clinical trials by ensuring patients could participate irrespective of their geographic location. This ambitious plan is showcased in their HIMSS23 presentations and will be further emphasized in the upcoming HIMSS25 conference. Mayo Clinic’s evolving strategy and foundational work aim to support study teams while prioritizing greater access and flexibility for trial participants. Over time, Mayo Clinic has progressed from strategizing and pilot implementations to full-scale execution, firmly positioning decentralized trials as a standard practice within the institution.
The driving force behind this initiative includes key figures such as Rebecca Kottschade, administrator of research operations; Dr. Tufia Haddad, chair of faculty development in the department of medical oncology; and Dr. Ugur Sener, a neuro-oncologist. Their collective efforts are focused on reevaluating and reimagining the structure of clinical trials to dismantle traditional barriers. They seamlessly integrate innovative technologies into the research process, ensuring that clinical trials are accessible to a more diverse patient population.
Empowering Study Teams and Enhancing Participant Engagement
One of the critical developments in Mayo Clinic’s CTBW initiative is the empowerment of study teams. Mayo has strategically provided study teams and investigators with dedicated navigational support, which includes optimizing processes, establishing vendor partnerships, creating self-service guides, and driving the adoption of decentralized capabilities. This support is crucial in enabling teams to integrate decentralized capabilities smoothly into their research programs, enhancing the overall execution and efficacy of clinical trials.
Mayo Clinic also emphasizes enhancing participant engagement to improve clinical trial accessibility and success rates. Through meticulous user experience research, valuable insights have been gathered to improve how Mayo connects with prospective trial participants. This research-driven approach ensures that participants have a more efficient and user-friendly trial experience. By tailoring the trial process to meet the varying needs of participants, Mayo Clinic achieves higher participation rates and better overall outcomes. The emphasis on user experience not only aids in participant recruitment but also enhances retention, making trials more robust and inclusive.
Developing Decentralized Best Practices
Mayo Clinic has made significant strides in developing and standardizing workflows for decentralized clinical trials (DCTs) by leveraging pilot studies. These pilot studies have been instrumental in refining and optimizing processes, ultimately establishing best practices for conducting decentralized trials. The institution’s focus extends to enhancing data governance, architecture, technology, and infrastructure to support the integration needs of novel wearables and sensors, which are critical to the success of decentralized trials.
To ensure continuous improvement, Mayo Clinic has established programmatic data and dashboards to track the DCT portfolio, capability utilization, and participant characteristics. These systems provide invaluable insights into the effectiveness of decentralized capabilities and help identify areas for further enhancement. By continuously refining these best practices based on real-world data and feedback, Mayo Clinic aims to make decentralized trials a standard practice across the institution. This systematic approach ensures that the benefits of decentralized trials are fully realized, improving trial access and efficiency.
Advancing Data Governance and Technology
A significant component of Mayo Clinic’s CTBW initiative lies in the advancement of data governance and technology. By focusing on enhanced data governance, architecture, technology, and infrastructure, Mayo Clinic supports the integration needs of innovative wearables and sensors. These advancements are essential for ensuring that data collected through decentralized trials are accurate, secure, and properly managed.
Efforts have also been dedicated to building essential digital products and platforms that streamline the end-to-end user experience for all stakeholders involved in DCTs. By simplifying the user experience, Mayo Clinic ensures that participants and study teams can navigate the trial process more efficiently, leading to better outcomes and higher participation rates. The integration of advanced technology and robust data governance not only enhances the trial process but also instills confidence in the participants and researchers. By prioritizing these elements, Mayo Clinic reinforces its commitment to innovation and excellence in clinical research.
Expanding Access and Improving Inclusion
One of the core objectives of Mayo Clinic’s CTBW program is to expand access to clinical trials. By reducing physical, logistical, and financial barriers, Mayo Clinic aims to create broader access to clinical trials, particularly benefiting patients who are geographically distant from research facilities. This approach empowers patients to participate in trials from the comfort of their homes or local communities, greatly enhancing the reach and inclusivity of clinical research.
In addition to expanding access, Mayo Clinic is dedicated to improving inclusion in clinical trials. Efforts are made to enhance the representation of diverse populations in clinical trials, ensuring that access to cutting-edge treatments is equitable. Inclusive trials provide a more comprehensive set of data, enabling researchers to develop treatments that are effective across a broader range of patients. By prioritizing diversity and inclusion, Mayo Clinic is committed to addressing health disparities and ensuring that all patients have the opportunity to benefit from participating in clinical research.
Scaling Adoption and Real-World Impact
Mayo Clinic is pioneering a major transformation in clinical trials by integrating advanced technologies. Their initiative, called Clinical Trials Beyond Walls (CTBW), seeks to decentralize clinical trials, making them more accessible, focused on patients, and efficient. By utilizing telehealth, remote assessments, and state-of-the-art innovations, Mayo Clinic is expanding clinical trials outside the limits of traditional research facilities. This approach allows them to reach patients in their homes and local communities. The COVID-19 pandemic played a crucial role in accelerating this shift, highlighting the necessity for flexible, accessible clinical trial models that can respond to global health challenges.
In this new era, clinical trials are no longer confined to physical locations but can adapt to the needs of diverse populations, providing more inclusive and comprehensive healthcare solutions. This approach not only brings the research directly to patients but also fosters a more personalized and respondent-friendly environment for participation in clinical studies.
