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

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Midcareer Investigator Award in Patient-Oriented Research (K24)
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Pediatrics Subcommittee (CHHD)
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Higgins, Rosemary
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Duke University
Other Clinical Sciences
Schools of Medicine
United States
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Autmizguine, Julie; Hornik, Christoph P; Benjamin Jr, Daniel K et al. (2015) Anaerobic antimicrobial therapy after necrotizing enterocolitis in VLBW infants. Pediatrics 135:e117-25
Bain, J; Benjamin Jr, D K; Hornik, C P et al. (2014) Risk of necrotizing enterocolitis in very-low-birth-weight infants with isolated atrial and ventricular septal defects. J Perinatol 34:319-21
Tremoulet, Adriana; Le, Jennifer; Poindexter, Brenda et al. (2014) Characterization of the population pharmacokinetics of ampicillin in neonates using an opportunistic study design. Antimicrob Agents Chemother 58:3013-20
Camelo Castillo, Wendy; Boggess, Kim; Stürmer, Til et al. (2014) Trends in glyburide compared with insulin use for gestational diabetes treatment in the United States, 2000-2011. Obstet Gynecol 123:1177-84
Greenberg, Rachel G; Benjamin Jr, Daniel K (2014) Neonatal candidiasis: diagnosis, prevention, and treatment. J Infect 69 Suppl 1:S19-22
Tunks, Robert D; Barker, Piers C A; Benjamin Jr, Daniel K et al. (2014) Sildenafil exposure and hemodynamic effect after Fontan surgery. Pediatr Crit Care Med 15:28-34
Aliaga, Sofia; Clark, Reese H; Laughon, Matthew et al. (2014) Changes in the incidence of candidiasis in neonatal intensive care units. Pediatrics 133:236-42
Autmizguine, Julie; Moran, Cassie; Gonzalez, Daniel et al. (2014) Vancomycin cerebrospinal fluid pharmacokinetics in children with cerebral ventricular shunt infections. Pediatr Infect Dis J 33:e270-2
Ericson, Jessica E; Benjamin Jr, Daniel K (2014) Fluconazole prophylaxis for prevention of invasive candidiasis in infants. Curr Opin Pediatr 26:151-6
Gonzalez, Daniel; Paul, Ian M; Benjamin Jr, Daniel K et al. (2014) Advances in pediatric pharmacology, therapeutics, and toxicology. Adv Pediatr 61:7-31

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