Advancing Clinical Trials at the Point of Care (ACT@POC)

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Project Report

Advancing Clinical Trials at the Point of Care (ACT@POC)

Published date

November 9, 2021

New Coalition Aims to Improve Patient Care and Address Unmet Medical Needs through Community-Level Clinical Trials

 

The Advancing Clinical Trials at the Point of Care (ACT@POC) coalition will generate quality clinical research evidence in real time to better evaluate treatments and therapeutics, including those to treat COVID-19. The Coalition will engage a broader, more diverse group of patients and providers and develop digital health tools that make clinical trials simpler to run and more accessible to patients. 

Currently, the complexity and cost of traditional clinical trials pose obstacles to patient and provider participation, identification of effective treatments for diseases, and the acceleration of new clinical insights and knowledge. This multi-stakeholder coalition aims to drive implementation of large-scale clinical trials at the community level—in the doctor’s offices and care facilities where most of the U.S. population receives care.

“The vast majority of patients and their providers do not participate in clinical trials,” said Dr. Mark McClellan, director of the Duke-Margolis Center for Health Policy. “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.”

Founding members of the coalition detail their collective commitment to this effort in an open letter. Founding ACT@POC members include: Duke-Margolis Center for Health Policy; MITRE; CURE Drug Repurposing Collaboratory (C-Path + NCATS+ FDA); Emory-Morningside Center for Innovative and Affordable Medicine; Intermountain Healthcare; Mayo Clinic; University of California, Irvine; Duke University Health System; and Broad Institute of MIT and Harvard. Its growing membership will include health systems, community-based care organizations, health research organizations, and other collaborators.

“Coalitions bring together multidisciplinary experts to solve the hardest problems,” said 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.”

The consequences of inefficient, low-value COVID-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 five percent 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,” said Dr. Brian Anderson, MITRE, chief digital health physician. “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 care givers 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 evidence generation capacity of the current clinical trial enterprise by working with patient groups, community hospitals and health centers, medical practices, research organizations, and biotechnology companies. In its work, the Coalition will target:

  • Engaging clinicians in a broader range of care settings
  • Developing and adopting effective data collection tools
  • Collaborating with clinical trial design leaders, regulators, funders, and other stakeholders to assure that clinical trial design features are fit for purpose
  • Enrolling diverse trial participants for broader participation in effective community-level trials
  • Addressing unmet medical needs by reaching a critical mass of participation in existing and new clinical trials
  • Improving technology supports and capabilities to conduct such studies over time

For more information about ACT@POC, please visit: Coalition for Advancing Clinical Trials (actpoc.org).

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Critical Path Institute

Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and dozens of pharmaceutical and biotech companies. C-Path US is headquartered in Tucson, Arizona and C-Path, Ltd. EU is headquartered in Dublin, Ireland, with additional staff in multiple other locations. For more information, visit c-path.org and c-path.eu.

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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.

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Morningside Center for Innovative and Affordable Medicine

The Morningside Center for Innovative and Affordable Medicine (Morningside Center) is an interdisciplinary unit within the Woodruff Health Sciences Center at Emory University. Extending the vision of GlobalCures Inc., a non-profit medical research organization, the Morningside Center was established at Emory in 2019 through a gift from the Morningside Foundation to promote research, education, and advocacy for effective and affordable medical treatments.

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Intermountain Healthcare

Located in Utah, Idaho, and Nevada, Intermountain Healthcare is a nonprofit system of 25 hospitals, 225 clinics, the Intermountain Medical Group with some 2,700 employed physicians and advanced care practitioners, a health plans division called SelectHealth, Homecare, and other health services. Helping people live the healthiest lives possible, Intermountain is committed to improving community health and is widely recognized as a leader in transforming healthcare by using evidence-based best practices to consistently deliver high-quality outcomes and sustainable costs.

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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.

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MITRE

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.

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UCI Health Affairs

Founded in 2017 with a $200 million gift from Orange County philanthropists Susan and Henry Samueli, UCI Health Affairs is a first of its kind health sciences enterprise and is unique to Orange County, Calif. Together, the Susan & Henry Samueli College of Health Sciences and UCI Health form UCI Health Affairs, led by Vice Chancellor Steve Goldstein, MA, MD, PhD, FAAP. Susan & Henry Samueli College of Health Sciences is translating our tripartite mission to “discover, teach, heal,” into the diverse healthcare workforce of the future and groundbreaking scientific discoveries. Creating a first-of-its-kind alliance across health disciplines, the college comprises the School of Medicine, the Sue & Bill Gross School of Nursing, the recently launched School of Pharmacy & Pharmaceutical Sciences, the future School of Population & Public Health (scheduled to be accredited in 2021), the Susan Samueli Integrative Health Institute, and research units focused on cancer, clinical translational science, precision health and stem cells. The college shares a robust synergy with UCI Health, the only academic health system in Orange County. UCI Health Affairs is transforming education, discovery, and patient care to benefit the region, state and nation.

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