UCI is among founding members of national coalition to improve clinical trials

Dr. Steve Goldstein, UCI’s vice chancellor for health affairsIrvine, Calif., November 9, 2021 —

The University of California, Irvine is a founding member of the Advancing Clinical Trials at the Point of Care coalition. Launched today, ACT@POC will generate high-quality clinical research evidence in real time to better evaluate treatments and therapeutics, including those to treat COVID-19. Its members 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.

“Academic health centers like those in ACT@POC are uniquely suited to lead improvements in clinical trials so they are inclusive and more rapidly employed to improve patient outcomes,” said Steve A.N. Goldstein, M.D., Ph.D., FAAP, vice chancellor for health affairs. “I am proud that UCI Health Affairs – which is advancing holistic approaches to supporting wellness and providing evidence-based, patient-centered, team-based healthcare – is a founding member of this national effort to make large-scale clinical trials in front-line settings accessible and responsive to the great diversity of patients and stakeholders across the nation.”

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.

Tom Andriola

“This coalition will advance data collection methods to greatly expand the number of sites and patients participating in clinical studies, especially for more diverse populations and underserved communities,” says Tom Andriola, UCI’s vice chancellor for information, technology and data and chief digital officer. Steve Zylius / UCI

“This coalition will advance data collection methods to greatly expand the number of sites and patients participating in clinical studies, especially for more diverse populations and underserved communities,” said Tom Andriola, vice chancellor for information, technology and data and chief digital officer. “The coalition also will be able to employ advanced analytical tools and methodologies for real-world evidence that can bring timely insights not just for the research setting but all the way back to front-line clinical practice.”

UCI is home to one of the leading health centers on the West Coast conducting clinical research, and it’s a site for myriad nationwide clinical trials, most notably in the areas of cancer and neuroscience. Dr. Daniela Bota, vice dean for clinical research and head of the UCI Center for Clinical Research, reports that UCI trials have increased by more than 36 percent in each of the last two years, with over 800 currently led by 215 principal investigators, representing $100 million in obligated costs.

Founding members of ACT@POC also include the Duke-Margolis Center for Health Policy, the MITRE Corp., the Cure Drug Repurposing Collaboratory, Duke University Health System, Emory University’s Morningside Center for Innovative and Affordable Medicine, Intermountain Healthcare, the Mayo Clinic and the Broad Institute. Its growing membership will encompass 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,” 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 on 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 percent had sufficient enrollment and key design features to yield actionable evidence. 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, chief digital health physician at 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 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. The coalition’s goals include:

  • 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 ensure that clinical trial design features are fit for purpose
  • Enrolling diverse trial participants in effective, community-level trials
  • Addressing unmet medical needs by reaching a critical mass of participation in existing and new clinical trials
  • Improving technological support for such studies over time