November 9th, 2021

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

Washington, DC—Launching today, 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. Found ACT@POC members include: Duke-Margolis Center for Health Policy; MITRE; CURE Drug Repurposing Collaboratory (C-Path + FDA); Emory-Morningside Center for Innovative and Affordable Medicine; Intermountain Healthcare; Mayo Clinic; University of California, Irvine: 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 (