Project Report
Advancing Clinical Trials at the Point of Care (ACT@POC)
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).
Additional Coalition Materials
Advancing Clinical Trials at the Point of Care Coalition: FAQs
Open Letter From Health Systems and Their Partners Committed to Better Evidence
Coalition Overview
Statements from Coalition Members
Coalition Members
Ascension
Ascension is committed to delivering compassionate, personalized care to all, with special attention to persons living in poverty and those most vulnerable.
The Broad Institute
The Broad Institute of MIT and Harvard is a research organization that convenes a community of researchers from across many disciplines and partner institutions—MIT, Harvard, and Harvard-affiliated hospitals.
Based in Cambridge, Massachusetts, the Broad Institute was founded in 2004 to fulfill the promise of genomic medicine—three years after completion of the Human Genome Project, which Broad scientists helped create and lead. Our origins are rooted in genomics, and as biomedical research and knowledge have expanded since 2004, so have we. Our researchers are deeply collaborative, nimbly launching innovative, high-risk projects at every scale, inventing new technologies, building and implementing computational tools, developing new therapeutics to advance into the clinic, mentoring and training the next generation of scientists, and sharing our data and tools openly to enable breakthroughs anywhere.
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.
CVS Health
CVS Health helps people with their health wherever and whenever they are needed. And they do it with heart. Because our passion their our purpose: Bringing our heart to every moment of your health™.
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.
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.
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.
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.
Medable
Medable is on a mission to get effective therapies to patients faster by transforming clinical drug development with disruptive technologies.
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.
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.
Vanderbilt University Medical Center
Managing more than 2 million patient visits each year, Vanderbilt University Medical Center (VUMC) is one of the largest academic medical centers in the Southeast, and is the primary resource for specialty and primary care in hundreds of adult and pediatric specialties for patients throughout Tennessee and the Mid-South. The School of Medicine’s biomedical research program is among the nation’s top 10 in terms of National Institutes of Health peer review funding, receiving more than $500 million in public and private awards during 2016. The Medical Center is the region’s locus of postgraduate medical education, with over 1,000 residents and fellows training in more than 100 specialty areas. Vanderbilt University Adult Hospital and the Monroe Carell Jr. Children’s Hospital at Vanderbilt are recognized each year by U.S. News & World Report’s Best Hospitals rankings as national leaders, with 19 nationally ranked adult and pediatric specialties. Through the Vanderbilt Health Affiliated Network, VUMC is working with over 60 hospitals and 5,000 clinicians across Tennessee and five neighboring states to share best practices and bring value-driven and cost-effective health care to the Mid-South.
Our Mission
Through the exceptional capabilities and caring spirit of its people, Vanderbilt will lead in improving the healthcare of individuals and communities regionally, nationally and internationally. We will combine our transformative learning programs and compelling discoveries to provide distinctive personalized care.
