The Investigator, Daniel K. Benjamin, Jr., MD, PhD, MPH, will prepare pediatricians for a career in clinical research that uses rigorous quantitative methods. Historically, 75% of drug products have insufficient labeling information needed for pediatric dosing, safety or efficacy. Dr. Benjamin's long-term research goal is to improve pediatric drug development by establishing proper dosing, safety, and efficacy of drugs used in adolescents, children, toddlers, infants, and neonates.
The specific aims are to prepare trainees fora career in acadmic medicine in one of: 1) clinical pharmacology;2) epidemiology and translational research;or 3) biostatistics and clinical trials. In order to fulfill these aims, fellows in the quantitative research methods program obtain formal training in biostatistics, epidemiology, or pharmacology and complete a Masters or PhD degree during their fellowship and first 24 months as faculty. Dr. Benjamin's research plan includes the multisite NICHD-sponsored protocol """"""""Meropenem Pediatric Off-Label Drug Study"""""""" and the proposed """"""""Antimicrobial Pharmacokinetics in High Risk Infants II"""""""" study. Dr. Benjamin also serves as Protocol Chair for 5 protocols sponsored through public-private partnerships between the National Institutes of Health and pharmaceutical industry. Strengths of his program include ongoing funding and active participation in several areas of neonatal pharmacology and therapeutics, including his role as Principal Investigator of the NICHD-sponsored North Carolina Collaborative Pediatric Pharmacology Research Unit (PPRU) site. The North Carolina PPRU ts a collaboration between Duke Pediatrics (Benjamin: PI) and the University of North Carolina School of Pharmacy (Thakker: co-Pi), which serves as a platform for training pediatricians in clinical pharmacology. Dr. Benjamin has formal training and a proven publication record in epidemiology and biostatistics. His expertise in these fields is further demonstrated by his leadership role directing pediatric quantitative analyses within the NCRR-sponsored Duke Clinical and Translational Science Award (CTSA). Feasibility of this program is shown by a proven track record in publications (58 peer-reviewed articles and abstracts) for which trainees are first author, and by the 16 trainees who are enrolled in or have completed masters or PhD degrees in health sciences, epidemiology, biostatics, or pharmacology. These research projects and institutional initiatives made possible by the Duke CTSA and Dr. Benjamin's collaboration with University of North Carolina combine perfectly with his role as Chief of the Division of Quantitative Sciences in the Department of Pediatrics at Duke University, and Fellowship Director of the Duke Clinical Research Institute
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