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 conditions such as 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 create an infrastructure for community-engaged research interventions for these three neurological conditions that affect brain health.
Historically, clinical trials for neurological diseases have not consistently or holistically included the voice of underserved communities who bear the brunt of the disease. If community input is part of the research design from the beginning, the clinical trial will more likely include a wider patient population and the research findings and results will be more applicable to the wider range of patients affected by the conditions.”
Anjail Z. Sharrief, MD, MPH, principal investigator for the trial and professor in the Department of Neurology at the McGovern School of Medicine at UTHealth Houston
For example, Sharrief said, designing clinical trials that require patients to come to the clinic during the work week instead of on Saturdays limits the ability of low-wage earners who would lose income by participating. Follow-up video visits instead of in-person visits also make a clinical trial easier for people to participate in. Including funding for transportation and bilingual research staff would also make it easier for individuals from underserved communities to participate.
“We often develop tests for what we, the researchers, are able to do, not what the community can do,” Sharrief said.
The project will establish a Brain Health Equity Collaborative to facilitate academic and community partnerships to develop clinical trials. The collaboration will include a community advisory board to review consent forms, assessment questions and other elements of a research trial to ensure it is relevant to a broad range of patients. A community oversight committee will ensure that the voices of patients and caregivers are heard and that trials adhere to protocols for community involvement.
“When you can’t recruit patients from certain communities to participate in a clinical trial, it’s not just a question of trust or interest — you’ve made it very difficult for them to participate,” Sharrief said. “This is extremely 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 Men’s Wellness Service and the Christopher Pichon II Foundation.
Co-investigators for the trial from the McGovern Medical School Department of Neurology are Elizabeth Noser, MD, associate professor, and the 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 the UTHealth Houston School of Public Health; Amy Franklin, PhD, associate professor and associate dean for student, faculty and community affairs at 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. Sharrief, Yamal, Noser and Anderson are members of the UTHealth Houston Institute for Brain and Cerebrovascular Diseases.
Funding came from the National Institute of Neurological Disorders and Stroke (1R01NS40001-01), part of the NIH.
