Mentorship of early-career pediatricians in quantitative methods and therapeutics

为早期职业儿科医生提供定量方法和治疗学方面的指导

• 批准号: 9070456
• 负责人: DANIEL K. BENJAMIN
• 金额: $ 13.84万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-01 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9070456
• 关键词: Adolescent; Adult; Award; Biometry; California; Cerebrospinal Fluid; Child; Child health care; Childhood; Clinical Pharmacology; Clinical Research; Clinical Trials; Cohort Studies; Data; Development; Doctor of Philosophy; Dose; Drug Kinetics; Drug usage; Educational Status; Ensure; Epidemiologic Studies; Epidemiology; Extramural Activities; Faculty; Fellowship; Funding; Future; Goals; Health; Health Sciences; Hospitals; Infant; Institution; Investigation; Knowledge; Label; Lead; Licensing; Longevity; Medical; Mentors; Mentorship; Methods; National Institute of Child Health and Human Development; North Carolina; Pathway interactions; Peer Review; Pharmaceutical Preparations; Pharmacoepidemiology; Pharmacology; Pharmacy Schools; Physicians; Principal Investigator; Public Health; Publications; Recording of previous events; Recruitment Activity; Research; Research Infrastructure; Research Institute; Research Personnel; Research Project Grants; Research Support; Research Training; Resources; Role; Safety; Secure; Services; Statutes and Laws; Therapeutic; Therapeutic Agents; Therapeutic Uses; Time; Toddler; Training; Training Programs; United States; United States Food and Drug Administration; United States National Institutes of Health; Universities; University Hospitals; Work; antimicrobial; base; career; career development; data management; drug development; educational atmosphere; expectation; experience; high risk infant; improved; mid-career faculty; neonate; next generation; patient oriented research; pediatric department; pediatrician; pharmacokinetic model; professor; programs; skills; statistics; success; trial design

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）：从历史上看，有75％的药物没有足够的标签来告知医生儿科剂量，安全性或功效。需要研究新产品的机制相对较新，并突出了与治疗剂研究相关的儿科医生的培训差距：迫切需要训练有素的儿科研究人员具有药理学，流行病学和生物统计学方面的定量研究技能。在这种竞争性更新中，调查员丹尼尔·K·本杰明（Daniel K. Benjamin，Jr。 根据他自己的长期研究目标：通过确定在青少年，儿童，幼儿，婴儿和新生儿中使用的药物的适当剂量，安全性和功效来改善小儿药物的开发。 本杰明博士通过制定一项儿科临床药理学和治疗剂研究计划，成功地实现了原始奖项中概述的目标。该计划的核心是申请人是PI和椅子的NICHD赞助的儿科试验网络（PTN）。该网络有27项积极的临床试验和药物ePidemiology项目，评估了38种治疗学的药代动力学，安全性和功效。该计划的广度是可能的，因为候选人成功地培养了三位年轻的调查员，他们获得了自己的NIH资金和自己的受训者。 除了在应用期间提供研究机会外，本杰明博士的计划的优势还包括世界上最大的学术研究组织，杜克临床研究所的无与伦比的研究基础设施，以及与著名的北卡罗来纳大学药学院与著名的学术合作。通过这种整体合作伙伴关系，本杰明博士开发了一项由NIH赞助的奖学金培训计划，并为儿科医生提供了确保临床药理学和药物epidemiology的博士水平培训的途径。 在这种竞争性更新中，申请人试图继续使用PTN作为来自杜克大学内外的年轻调查员的指导平台。美国临床药理学学员将被招募以领导网络研究项目。具体而言，拟议的“高风险婴儿中的抗菌脑脊液药代动力学” PTN研究将为受训者提供了本杰明博士开发的研究计划的机会。 通过受训者的出版物记录（超过90个同行评审的文章，作为第一作者作为第一作者，以及其他机构的年轻调查人员的最初指导者，来自其他机构的其他机构，来自其他机构的儿童医院，包括90多名受训者，包括90多个同行评审的文章，包括90多名同行评审的文章，包括其他机构的儿童Mercy Hospital，Ulias Viraia，Univily，大学和大学的最初指导。