ROCHESTER, Minn. — Mayo Clinic and several health organizations launched the Advancing Clinical Trials at the Point of Care Coalition to improve patient care by giving clinicians quality clinical research evidence in real time to better evaluate treatments and therapeutics, including those to treat COVID-19. The ACT@POC coalition will bring together health systems, community-based care organizations, health research organizations and a more diverse group of patients and providers to support the design of adaptable clinical trials and develop digital health tools that make clinical trials simpler to conduct and more accessible to patients.

The complexity and cost of traditional clinical trials pose obstacles to patient and provider participation, identification of effective treatments for diseases, and acceleration of new clinical insights and knowledge. This coalition aims to drive implementation of large-scale clinical trials at the community level — in health care providers' offices and care facilities where most people in the U.S. receive care.

Coalitions bring together multidisciplinary experts to solve the hardest problems," says John Halamka, M.D., president, Mayo Clinic Platform. "We have assembled leaders in clinical trials, informatics and public policy to accelerate cures using real-world evidence and advance patient care."

Mayo Clinic and the founding coalition members detail their collective commitment to this effort in an open letter.

Founding ACT@POC members are:

• Duke-Margolis Center for Health Policy.
• The MITRE Corp.
• CURE Drug Repurposing Collaboratory (Critical Path Institute, National Center for Advancing Translational Sciences, and Food and Drug Administration).
• Emory-Morningside Center for Innovative and Affordable Medicine.
• Intermountain Healthcare.
• University of California, Irvine.
• Duke University Health System.
• Broad Institute of Massachusetts Institute of Technology and Harvard University.

Its growing membership will include health systems, community-based care organizations, health research organizations and other collaborators.

"The vast majority of patients and their providers do not participate in clinical trials," says Mark McClellan, M.D., Ph.D., director of the Duke-Margolis Center for Health Policy, and a co-founder of the ACT@POC. "Through its more accessible, cost-effective and inclusive approach, the Advancing Clinical Trials at the Point of Care Coalition will help the clinical trial enterprise answer priority research questions for COVID-19, prepare for future public health emergencies, and address common diseases where there is long-standing unmet medical need, including cardiovascular and neurological diseases."

The consequences of inefficient, low-value, COVID-19-related clinical research made the need for a coalition to support inclusive and efficient clinical trials apparent. One analysis found that, of 2,610 trials of existing drugs repurposed as COVID-19 therapeutics, only 5% had sufficient enrollment and key design features to yield actionable evidence to combat COVID-19. Further, only a tiny fraction of Americans diagnosed with COVID-19 participated in those trials.

"COVID-19 has required health systems and public health experts to rely on data for decision-making to quickly gain insights that could deliver better patient outcomes," says Brian Anderson, M.D., chief digital health physician for the MITRE. "The answers to many research questions can be found in the data and allow for engagement of patients in underserved communities who are often left out of traditional clinical research trials. By working with clinicians who are the trusted caregivers of underserved communities, we hope to more fully engage and reach people through this collaboration to help yield new answers to many public health diseases."

The coalition's agenda and action steps aim to substantially augment the clinical trials capacity and effectiveness as well as the evidence generation by working with patient groups, community hospitals and health centers, medical practices, research organizations, and biotechnology companies.

In its work, the coalition will:

• Engage clinicians in a broader range of care settings.
• Develop and adopt effective data collection tools.
• Collaborate with clinical trial design leaders, regulators, funders and other stakeholders to ensure clinical trial design features are a fit for the desired purpose.
• Enroll diverse trial participants for broader participation in effective community-level trials.
• Address unmet medical needs by reaching a critical mass of participation in existing and new clinical trials.
• Improve technology supports and capabilities to conduct such studies over time.

###

About Duke-Margolis Center for Health Policy
The mission of the Duke-Margolis Center for Health Policy at Duke University is to improve health, health equity, and the value of health care through practical, innovative, and evidence-based policy solutions. For more information, visit healthpolicy.duke.edu and follow us on Twitter @DukeMargolis.

About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and providing compassion, expertise and answers to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news. For information on COVID-19, including Mayo Clinic's Coronavirus Map tracking tool, which has 14-day forecasting on COVID-19 trends, visit the Mayo Clinic COVID-19 Resource Center.

About the MITRE Corporation
MITRE’s mission-driven teams are dedicated to solving problems for a safer world. Through our public-private partnerships and federally funded R&D centers, we work across government and in partnership with industry to tackle challenges to the safety, stability, and well-being of our nation.

Media contacts:

• Duska Anastasijevic, Mayo Clinic Public Affairs, newsbureau@mayo.edu
• Patricia Shea Green, Duke-Margolis Center for Health Policy, 301-520-6482, patricia.s.green@duke.edu

Related Articles