Integrating Special Populations into Clinical Research

Geriatrics

Director

Holly Holmes, MD, Holly.M.Holmes@uth.tmc.edu, 713-500-6628

The CCTS has access to diverse populations of older adults across its catchment area with significant burden of chronic illness. Recent advancements include a study led by Dr. Holly Holmes evaluating whether a pharmacist-led deprescribing intervention can decrease adverse drug reactions, healthcare utilization, and cost. The CCTS has also funded pilot studies for new investigators, such as one conducted by Dr. Jessica Lee in collaboration with UTMB and UT San Antonio, examining the effects of intranasal oxytocin on sarcopenic obesity. Other studies include the AstraZeneca COVID-19 vaccine trial with Lee and Dr. Carmel Dyer as co-investigators. A site PI and supervisor for a trial of statins for primary prevention of dementia and disability (PREVENTABLE), Lee has formed unique partnerships with community organizations. She is conducting an exercise clinical trial for homebound older adults in collaboration with the community organization Meals on Wheels. Another longitudinal study in Brownsville, with the CCHS, has recruited more than 400 primarily elderly participants which has helped uncover new associations between chronic diseases in older people, such as diabetes and osteoporosis. Dr. Rianon works in close collaboration with the UT School of Public Health in Brownsville in these studies.

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Pediatrics

Director

Jon Tyson, MD, MPH, Jon.E.Tyson@uth.tmc.edu, 713-500-5651

Dr. Tyson leads a team of CCTS investigators in conducting innovative and rigorous research for patients from the fetal stage up to age 18. Among their contributions, Claudia Pedroza, PhD, Charles Green, PhD, and Dr. Tyson have been leaders in pioneering the use of Bayesian design and analysis of clinical trials, particularly perinatal and pediatric studies, to address the limitations of traditional frequentist statistics and to quantify the probability and magnitude of benefit/harm from medical or surgical interventions. The work includes assisting in perinatal studies led by Sean Blackwell, MD, Suneet Chauhan, MD, and other maternal-fetal medicine specialists. CCTS investigator, Joyce Samuel, MD, MS, has led in promoting the use of n-of-1 trials as a method to identify the best treatment for individual patients, including children with hypertension whose response to different medications is quite variable and unpredictable. Ricardo Mosquera, MD, MS, and Elenir Avritscher, MD, PhD, MBA, have developed a nationally renowned program for medically complex children and demonstrated its effectiveness and cost effectiveness in progressively reducing their rates of serious illnesses and health system costs.

Drs. Tyson, Pedroza, and Green have been leaders in randomized trials and cohort studies of the NICHD Neonatal Research Network that are needed to resolve major controversies in the care of high-risk newborns and are often published in The New England Journal of Medicine and JAMA. These include the study by Drs. Tyson and Green that developed an internet tool to assess the prognosis of marginally viable newborns and assist in counseling the parents of these infants. Matthew Rysavy, MD, PhD, and Dr. Tyson recently updated this tool, which is accessed more than 30,000 times per year by neonatologists and parents in developed countries worldwide. Drs. Tyson and Rysavy are leading several major Network studies, including a trial of cycled phototherapy to increase the likelihood of survival without impairment among extremely premature infants.

To participate in similar perinatal and pediatric studies, or to apply research methods of the kind referenced above in studies of patients of any age, please contact Dr. Tyson.

Border Health

Directors

Kari E. North, PhD, Kari.E.North@uth.tmc.edu, 956-755-0600
Susan P. Fisher-Hoch, MD, Susan.P.Fisher-Hoch@uth.tmc.edu, 956-755-0635
Joseph B. McCormick, MD, Joseph.B.McCormick@uth.tmc.edu, 956-755-0605

Thanks to the foresight of Drs. Fisher-Hoch and McCormick, the CCTS has access to an extensive databank representing underserved populations along the U.S.-Mexico border, primarily in Brownsville, Texas. Under McCormick's direction, the Cameron County Hispanic Cohort (CCHC) was established in 2004 with funding from a P20 grant from the National Institutes of Health under the umbrella of the Hispanic Health Research Center. Since that time, the couple has overseen the clinical research unit in Brownsville, which has conducted a range of studies related to public health, including chronic and infectious diseases.

The CCHC includes more than 5,000 individuals, ages 8 and up, from the communities of Brownsville, Harlingen, and Laredo. It is the largest cohort of its kind in the U.S. The random protocol allows the research team to estimate prevalence of chronic disease in the population. Participants agree to provide extensive household data and subsequently complete health questionnaires, physical measurements, and imaging. Also collected and stored are serial serum, plasma, DNA, RNA, urine, and stool specimens. Follow-up visits are conducted every five years, with data in the biobank going back more than 20 years. The innovative model assesses changes in disease patterns over time and associates them with changes in the transcriptome, proteome, lipidome, and gene methylation thanks to the longitudinal biobank.

The research made possible by the cooperation of of CCHC participants has resulted in broad-based and unique medical discoveries. Among the most significant is the incidence of liver disease and cancer mostly associated with diabetes and obesity. Collaborative research with Dr. Laura Beretta from The University of Texas MD Anderson Cancer Center has revealed a high prevalence of liver disease (a precursor to liver cancer driven by obesity), a general lack of proper diabetes management, and little to no access to health care.

Populations in Low-resource Settings

Director

Vanessa Schick, PhD, Vanessa.Schick@uth.tmc.edu, 713-500-9398

The CCTS has a history of supporting community-engaged research and community organizations that serve populations in low-resource settings. (Read more about the Community Health Initiated Research Partnerships (CHIRP) Fellowship program.) Dr. Schick's primary focus is to increase engagement and retention of these populations in clinical and translational research. Her efforts include providing education, training, and testing by leveraging local resources.