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

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Midcareer Investigator Award in Patient-Oriented Research (K24)
Project #
5K24HD058735-04
Application #
8292248
Study Section
Pediatrics Subcommittee (CHHD)
Program Officer
Higgins, Rosemary
Project Start
2009-07-01
Project End
2014-06-30
Budget Start
2012-07-01
Budget End
2013-06-30
Support Year
4
Fiscal Year
2012
Total Cost
$153,809
Indirect Cost
$11,105
Name
Duke University
Department
Other Clinical Sciences
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Momper, Jeremiah D; Capparelli, Edmund V; Wade, Kelly C et al. (2016) Population Pharmacokinetics of Fluconazole in Premature Infants with Birth Weights Less than 750 Grams. Antimicrob Agents Chemother 60:5539-45
Gonzalez, Daniel; Palazzi, Debra L; Bhattacharya-Mithal, Leena et al. (2016) Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents. Antimicrob Agents Chemother 60:2572-6
Ericson, Jessica E; Kaufman, David A; Kicklighter, Stephen D et al. (2016) Fluconazole Prophylaxis for the Prevention of Candidiasis in Premature Infants: A Meta-analysis Using Patient-level Data. Clin Infect Dis 63:604-10
Autmizguine, Julie; Hornik, Christoph P; Benjamin Jr, Daniel K et al. (2016) Pharmacokinetics and Safety of Micafungin in Infants Supported With Extracorporeal Membrane Oxygenation. Pediatr Infect Dis J 35:1204-1210
Romaine, Andrew; Ye, Daniel; Ao, Zachary et al. (2016) Safety of histamine-2 receptor blockers in hospitalized VLBW infants. Early Hum Dev 99:27-30
Gonzalez, Daniel; Delmore, Paula; Bloom, Barry T et al. (2016) Clindamycin Pharmacokinetics and Safety in Preterm and Term Infants. Antimicrob Agents Chemother 60:2888-94
Thakkar, N; Gonzalez, D; Cohen-Wolkowiez, M et al. (2016) An opportunistic study evaluating pharmacokinetics of sildenafil for the treatment of pulmonary hypertension in infants. J Perinatol 36:744-7
Thaden, Joshua T; Ericson, Jessica E; Cross, Heather et al. (2015) Survival Benefit of Empirical Therapy for Staphylococcus aureus Bloodstream Infections in Infants. Pediatr Infect Dis J 34:1175-9
Ericson, Jessica E; Thaden, Joshua; Cross, Heather R et al. (2015) No survival benefit with empirical vancomycin therapy for coagulase-negative staphylococcal bloodstream infections in infants. Pediatr Infect Dis J 34:371-5
Trachtman, H; Frymoyer, A; Lewandowski, A et al. (2015) Pharmacokinetics, Pharmacodynamics, and Safety of Lisinopril in Pediatric Kidney Transplant Patients: Implications for Starting Dose Selection. Clin Pharmacol Ther 98:25-33

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