Translational and Clinical Pharmacology Research
Researchers in the Cincinnati Children’s Division of Translational and Clinical Pharmacology conduct and support investigator-initiated clinical studies to ensure the availability of safe medicines for children. Our team improves new and existing drug therapies in neonates, infants, children, adolescents and young adults.
Our faculty conducts clinical, translational and basic research to further our understanding of how the youngest patients metabolize and react to medications.
Partnering with faculty in multiple divisions, we complete studies that promote and enhance the development, rational use and individualization of drug prescriptions. This collaboration helps clinicians increase drug efficacy and reduce toxicity by optimizing drug selection and personalizing drug dosing.
We provide model-informed precision dosing, therapeutic drug management (TDM) and pharmacogenetic testing to provide the best care for children. Our Laboratory of Applied Pharmacokinetics and Therapeutic Drug Management serves patients with recurrent sub- or super-therapeutic drug concentrations or drug treatment failures.
Our Research
Thanks to our research, Cincinnati Children’s is one of the first hospitals to offer genetic testing that helps doctors and nurses choose and dose medication to best meet the needs of an individual patient.
Projects our faculty work on are tied to pharmacogenetics, population pharmacokinetic-pharmacodynamic (PK/PD) analysis and modeling (pharmacometrics), as well as clinical trial design and simulation.
As part of the Genetic Pharmacology Service, we investigate new methods to reduce adverse drug reactions. We identify genetic variations in drug metabolism, providing dose recommendations based on a patient’s drug metabolizing genotype and phenotype. We also delineate clinically significant drug interactions.
Research in Translational and Clinical Pharmacology strives to:
- Develop dosing algorithms and expert systems for individualized drug therapy
- Provide customized drug dosing recommendations to pediatric patients based on TDM results
- Allow patients to achieve the best possible clinical outcome with the fewest side effects
- Develop new approaches for how we study the effects of medications in children
Most of our work is in collaboration with other Cincinnati Children’s divisions and centers, including:
- Allergy and Immunology
- Anderson Center for Health Systems Excellence
- Anesthesiology
- Audiology
- Bone Marrow Transplantation and Immune Deficiency
- Critical Care
- Developmental and Behavioral Pediatrics
- Gastroenterology and Hepatology
- Hematology
- Hospital Medicine
- Human Genetics
- Infectious Diseases (microbiome)
- Neonatology
- Perinatal Institute
- Nephrology and Hypertension
- Neurology
- Oncology
- Pathology (special chemistry/mass spectrometry facility)
- Psychiatry
- Patient Services
- Rheumatology
Our program promotes the 2002 Best Pharmaceuticals for Children Act (BPCA), which set a process for studying on-patent and off-patent drugs for use in pediatric populations. We respond to demands for pediatric clinical drug studies, including those by the U.S. Food and Drug Administration (FDA) Modernization Act and the FDA 1998 Pediatric Rule.
This is important because:
- Many routinely prescribed medicines are not well studied in the pediatric population. This is particularly true for critically ill newborns, in whom up to 75% of medicines used have not been adequately studied.
- Pharmacokinetic study and therapeutic drug management can help tailor doses to individual needs, prevent drug-drug interactions and avoid adverse events in pediatric patients.
- Pharmacogenetics research shows children metabolize drugs in widely differing ways.
Preparing Future Pediatric Clinician Scientists
Translational and Clinical Pharmacology faculty and research teams provide multimodality clinical pharmacology teaching that enhances the knowledge of residents, fellows and faculty.
We guide and train graduate students within the University of Cincinnati College of Medicine and the College of Pharmacy. We hold T32 and K12 training grants from the National Institutes of Health that support our work in preparing the next generation of pediatric clinician scientists.
The individualized Clinical Pharmacology Fellowship prepares our postdoctoral fellows for leadership roles. Fellows learn to develop innovative, high impact clinical and developmental pharmacology that improves the use of medicines in children.
