Irvine, Calif., Nov. 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.
“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
About the University of California, Irvine: Founded in 1965, UCI is the youngest member of the prestigious Association of American Universities and is ranked among the nation’s top 10 public universities by U.S. News & World Report. The campus has produced three Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UCI has more than 36,000 students and offers 224 degree programs. It’s located in one of the world’s safest and most economically vibrant communities and is Orange County’s second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide. For more on UCI, visit www.uci.edu.
About 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 science enterprise and is unique to Orange County, California. Together, the Susan & Henry Samueli College of Health Sciences, UCI Health, and health-focused centers and institutes form UCI Health Affairs, led by Vice Chancellor Steve Goldstein, M.D., Ph.D., FAAP. Health Affairs has a tripartite mission to “discover, teach, heal” in the service of creating the diverse healthcare workforce of the future and driving scientific discoveries to advance wellness, precision care and health equity. 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, and the Susan Samueli Integrative Health Institute. The research centers and institutes are focused on cancer, clinical translational science, precision health informatics, clinical trials and stem cells. UCI Health is the only academic health system in Orange County, the sixth-largest county in the nation. UCI Health Affairs is transforming education, discovery and patient care to benefit the region, state and nation. For more, visit https://www.cohs.uci.edu/about/index.php.
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About UCI’s Brilliant Future campaign: Publicly launched on Oct. 4, 2019, the Brilliant Future campaign aims to raise awareness and support for UCI. By engaging 75,000 alumni and garnering $2 billion in philanthropic investment, UCI seeks to reach new heights of excellence in student success, health and wellness, research and more. To learn more about activities to support in Health Affairs, please visit: https://brilliantfuture.uci.edu/uci-health-affairs.