Historically, 75% of drugs have insufficient labeling to inform physicians on pediatric dosing, safety, or efficacy. Mechanisms requiring the study of new products in children are relatively new and highlight a training gap in pediatricians related t the investigation of therapeutic agents: There is an urgent need for well-trained pediatric investigators with quantitative research skills in pharmacology, epidemiology, and biostatistics. In this competitive renewal, the investigator, Daniel K. Benjamin, Jr., MD, PhD, MPH, will continue to prepare pediatricians for a career in patient-oriented research to help bridge this gap in accordance with his own long-term research goals: to improve pediatric drug development by establishing proper dosing, safety, and efficacy of drugs used in adolescents, children, toddlers, infants, and neonates. Dr. Benjamin successfully achieved the aims outlined in the original award by developing a research program in pediatric clinical pharmacology and therapeutics. The centerpiece of the program is the NICHD- sponsored Pediatric Trials Network (PTN) for which the applicant is PI and chair. The network has 27 active clinical trials and pharmacoepidemiology projects evaluating the pharmacokinetics, safety, and efficacy of 38 therapeutics. The breadth of the program is possible because the candidate successfully developed three young investigators who have secured their own NIH funding and their own mentees. In addition to offering research opportunities for the duration of the application, strengths of Dr. Benjamin's program include the unparalleled research infrastructure of the world's largest academic research organization, Duke Clinical Research Institute, and a longstanding academic partnership with the renowned University of North Carolina School of Pharmacy. Through this integral partnership, Dr. Benjamin has developed an NIH-sponsored fellowship training program and a pathway for pediatricians to secure PhD- level training in clinical pharmacology and pharmacoepidemiology. In this competitive renewal, the applicant seeks to continue using the PTN as a platform for mentorship of young investigators from both within and outside Duke University. Trainees in clinical pharmacology across the US will be recruited to lead network research projects. Specifically, the proposed """"""""Antimicrobial Cerebrospinal Fluid Pharmacokinetics in High-Risk Infants"""""""" PTN study will offer mentees the opportunity to capitilize on the research program that Dr. Benjamin has developed. Feasibility of the proposed program expansion to national prominence and multi-institutional collaborative mentorship is shown by funding and career development of current trainees at Duke and UNC, by trainees'publication track record (over 90 peer-reviewed articles with trainees as first author, and by the initial mentorship of young investigators from other institutions including Children's Mercy Hospital, University of Louisville, and University California-San Diego.

Public Health Relevance

The applicant has built a successful program in pediatric clinical pharmacology and therapeutics, and seeks to expand upon that success through the mentorship of Duke University trainees and junior investigators from throughout the United States using the Pediatric Trials Network as a national resource to conduct high-quality, patient-oriented research.

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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Developmental Biology Subcommittee (CHHD)
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Higgins, Rosemary
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Duke University
Other Clinical Sciences
Schools of Medicine
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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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