In an effort to close the gap in neurological outcomes for underserved populations, a UTHealth Houston project funded with $2.9 million from the National Institutes of Health (NIH) will engage community partners to improve clinical trial design.
Neurological disorders, including stroke, Parkinson’s disease and vascular cognitive impairment and dementia, contribute to the leading causes of death and disability in the US. The goal of the project is to build an infrastructure for community-based research interventions for the three neurological disorders that affect brain health.
Historically, clinical trials of neurological disorders have not consistently or holistically heard the voices of underserved communities who bear the greatest burden of disease. “If community input is part of the research plan from the start, the clinical trial will likely include a broader patient population, and the study findings and outcomes will be more applicable to the broader range of patients affected by the conditions.”
Anjail Z. Sharief, MD, MPH, principal investigator for the trial and professor in the Department of Neurology at UTHealth Houston’s McGovern Medical School
For example, Sharief said that designing clinical trials that require patients to come to the clinic during the work week instead of on Saturdays limits the options of lower-wage earners who would lose income by participating. Follow-up television visits instead of in-person visits also make it easier for people to participate in a clinical trial. Including funding for transportation and bilingual research staff would also make it more possible for people from underserved communities to participate.
“We often develop trials for what we, the researchers, can do, not for what the community can do,” Sharief said.
The project will establish a Brain Health Equity Collaborative to facilitate academic and community partnerships for clinical trial development. The partnership includes a community advisory board that reviews consent forms, assessment questions and other components of a research trial to ensure they are recognizable to a wide range of patients. A community oversight committee will ensure that the voices of patients and caregivers are heard and that the studies adhere to community engagement protocols.
“If you can’t recruit patients from certain communities to participate in a clinical trial, it’s not just a matter of trust or interest — you’ve made it too difficult for them to participate,” Sharief said. “This is super exciting because it combines our passion for research with our commitment to community engagement and empowerment.”
Community partners include ProSalud, Gulfton Home Community, African American Male Wellness Agency and the Christopher Pichon II Foundation.
Co-investigators for the study from McGovern Medical School’s Department of Neurology are Elizabeth Noser, MD, associate professor, and James C. Grotta, MD chair in Neurological Recovery and Stroke; Chigozirim Izeogu, MD, MPH, assistant professor; Mya Schiess, MD, professor, director of movement disorders and neurodegenerative diseases, and Adriana Blood Distinguished Chair in Neurology; Shivika Chandra, MD, associate professor and chief of neurology at Harris Health Lyndon B. Johnson Hospital; and Kendra Anderson, PhD, assistant professor.
Other co-investigators include Jose-Miguel Yamal, PhD, associate professor of biostatistics at UTHealth Houston School of Public Health; Amy Franklin, PhD, associate professor and associate professor of student, faculty and community affairs in the McWilliams School of Biomedical Informatics at UTHealth Houston; and Logan Thornton, DrPH, MPH, director of Population Health and Evidence-Based Practice Healthcare Transformation Initiatives at UT Physicians.
Yamal is a member of the University of Texas MD Anderson Cancer Center UTHealth Houston Graduate School of Biomedical Sciences. Sharief, Yamal, Noser and Anderson are members of the UTHealth Houston Institute for Stroke and Cerebrovascular Diseases.
Funding came from the National Institute of Neurological Disorders and Stroke (1R01NS40001-01), part of the NIH.