DALLAS, May 17, 2022 — Teams of research scientists from 11 universities and health care systems will lead a ground-breaking $20 million research project to study the barriers to ensuring people of diverse race and ethnicity are represented and included in clinical research trials, identify best practices to overcome those barriers and determine how solutions can be implemented across the research community. The Strategically-Focused Research Network (SFRN) on the Science of Diversity in Clinical Trials of the American Heart Association, the world’s leading voluntary organization dedicated to a world of longer, healthier lives, is funded in part by Pfizer and Gates Ventures.
Recognizing the long-standing lack of diversity among people participating in clinical trials for medical research, this research network is the latest initiative in the Association’s unprecedented pledge to aggressively address social determinants of health while working to improve health equity for all communities. While some of the new projects will focus on research for heart and brain health, the goal of the initiative is to identify best practices that can be easily replicated to ensure people of all races and ethnicities are fully included in medical research of all disease states.
“The American Heart Association is committed to investing in long-term solutions to ensure that the composition of the health care and research communities in the United States mirror our society at large. However, when it comes to clinical trials, there has long been a lack of representation from some populations including women and people of color,” said Donald Lloyd-Jones, M.D., Sc.M., FAHA, president of the American Heart Association and chair of the department of preventive medicine at Northwestern University Feinberg School of Medicine in Chicago. “There are many barriers that reduce or inhibit the inclusion of diverse populations in clinical research. Those may include a lack of access to medical care for screenings or referrals to clinical trials; distrust of the research community; cultural and language differences; literacy and technology challenges; and the persistence of structural racism in our processes and systems. We are proud to be a leader in identifying and addressing these barriers and look forward to the exciting work that will be forthcoming from these teams of prestigious research scientists.”
The four-year grant projects, which began on April 1, 2022, include:
- Diversity & Inclusion in cardioVascular trials through Enrollment and education Resulting in Sustainable Equity: DIVERSE – Researchers from Stanford University School of Medicine in Stanford, California and the Morehouse School of Medicine in Atlanta, will collaborate to conduct two large research studies to identify the best strategies for including people of diverse populations in clinical trials. The first study is comparing six different strategies in 112 different clinical trials randomizing at the site level across the country to determine which works best for different people. The second study works with doctors in communities to find what they and their patients need most to participate in clinical research trials. Researchers will train community doctors to identify and remove barriers to health care access and to enroll people in research trials which can help their patients have access to the latest therapies. The instructions and resource developed for community doctors and hospitals will be made widely available to health care professionals outside the study area. Additionally, the team will form a network of leading pharmaceutical companies, technology companies and minority health care institutions to work together to make clinical trials more inclusive. This collaborative team is led by Eldrin Lewis, M.D., M.P.H., FAHA, the Simon H. Stertzer, M.D. Professor of Medicine and chief of the division of cardiovascular medicine at Stanford University School of Medicine.
- Integrated Community Engaged, mHealth, and Data Science to Enhance Clinical Trial Diversity and Cardiometabolic Health (iDIVERSE) – Researchers from the University of California-Los Angeles (UCLA), the University of Hawaii (UH) in Honolulu and Washington State University (WSU) in Pullman will collaborate on projects addressing disparities in clinical research in multiple diverse populations. The center at UH focuses on Native Hawaiian and Pacific Islander participants; the WSU is working with Native American participants; and the center at UCLA is concentrating on African/Black, Asian/Filipino, and Latin American participants. Each center is conducting a clinical trial to treat heart disease, diabetes or obesity, using smartphones to stay in touch with participants throughout the project. The three complementary projects aim to mitigate cardiometabolic disparities and they will be thematically connected through mHealth approaches to improve recruitment, enrollment and participation of diverse individuals in clinical trials. The AHA iDIVERSE team will further provide diversity training and, where appropriate, machine learning approaches to advance health equity in clinical trials. This collaborative team is led by Tzung Hsiai, M.D., Ph.D., the Maud Cady Guthman Endowed Term Chair in Cardiology and a professor of medicine (cardiology) and bioengineering at UCLA, and co-directed by Keith C. Norris, M.D., Ph.D., executive vice chair for the Department of Medicine for Equity, Diversity, and Inclusion and a professor of medicine at UCLA and Keawe Kaholokula, Ph.D., a professor and chair of the Department of Native Hawaiian Health at University of Hawaii at Manoa.
- Behavioral Economics to Transform Trial Enrollment Representativeness (BETTER) – Researchers from the University of Pennsylvania (Penn) in Philadelphia, Emory University in Atlanta, Grady Health Systems in Atlanta and MedStar Washington Hospital Center in Washington, D.C., are collaborating to use behavioral health science to improve clinical trial participation among diverse groups. They will bring together experts in behavioral economics, research ethics, health equity and clinical trials to identify methods that make trial enrollment and retention easier for everyone. The BETTER Center team will study previous trials to learn from past successes and failures, engage people with heart disease from underserved racial groups to identify barriers to clinical trial enrollment, and then develop and test methods to improve the pace and diversity of trial enrollment. This collaborative team is led by Scott Halpern, M.D., Ph.D., M.B.E., the John M. Eisenberg, M.D. Professor in Medicine at the Perelman School of Medicine at Penn.
- Alzheimer's Trial Recruitment Innovation Lab (ATRIL): Reducing Bottlenecks and Achieving Diversity – Researchers from the University of Southern California’s (USC) Alzheimer’s Therapeutic Research Institute (ATRI) and USC’s Schaeffer Center for Health Policy & Economics in Los Angeles, and Howard University in Washington, D.C., are studying innovative ways to increase clinical trial participation among diverse and underrepresented populations, specifically for Alzheimer’s disease (AD), the most common form of dementia. With this funding, the team will conduct two research projects and establish a fellowship training program. The first project will test remote and in-person evidence-based recruitment models for clinical trial participation among diverse populations using community-based partnerships. The second project will evaluate the feasibility of unsupervised, web-based cognitive assessment tools to accelerate clinical trial engagement. Finally, the multidisciplinary fellowship program will train and develop future AD and AD-related dementia clinical trialists. This collaborative team is led by Rema Raman, Ph.D., a professor of neurology at USC’s Keck School of Medicine and director of biostatistics and recruitment at USC’s ATRI.
- Training Researchers to Advance Inclusion Networks (TRAIN) – A team at Stanford University School of Medicine in Stanford, Ca., and the Morehouse School of Medicine in Atlanta, is establishing the full network’s coordinated training center to develop science curriculum and career development training opportunities among the participating scientists, with the goal of enhancing diversity of clinical research participants. The program will specifically teach scientists how to do studies in full partnership with patients and communities through classes, community meetings and peer-to-peer learning. This training team is led by Hannah Valantine, M.B.B.S., M.D., a professor of medicine at Stanford. and Priscilla Pemu, M.B.B.S, M.S.C.R., a professor of medicine, the associate dean of clinical research and the director of the Clinical Research Center at Morehouse.
With the launch of this new network, the American Heart Association has now invested more than $250 million to establish a total of 14 Strategically Focused Research Networks, providing an opportunity to address key strategic issues that were identified by the Association’s Board of Directors. Networks have already been studying prevention; hypertension; disparities; women’s health; heart failure; obesity; children; vascular disease; atrial fibrillation; arrhythmias/sudden cardiac death; cardiometabolic health/type 2 diabetes, health technology and cardio-oncology. Each network centers around the scientific knowledge and knowledge gaps, prevention, diagnosis and treatment of the key research topic. Four to six research centers make up each network, bringing together investigators with expertise in basic, clinical and population/behavioral health science to find new ways to diagnose, treat and prevent heart disease and stroke.
The American Heart Association, the world's leading nonprofit organization focused on heart and brain health for all, is the largest not-for-profit funding source for cardiovascular and cerebrovascular disease research next to the federal government. Since 1949, the Association has invested more than $4.9 billion in cardiovascular, cerebrovascular and brain health research. New knowledge resulting from this funding benefits millions of lives in every corner of the U.S. and around the world.
About the American Heart Association
The American Heart Association is a relentless force for a world of longer, healthier lives. We are dedicated to ensuring equitable health in all communities. Through collaboration with numerous organizations, and powered by millions of volunteers, we fund innovative research, advocate for the public’s health and share lifesaving resources. The Dallas-based organization has been a leading source of health information for nearly a century. Connect with us on heart.org, Facebook, Twitter or by calling 1-800-AHA-USA1.
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