Cincinnati Training Program in Pediatric Clinical and Developmental Pharmacology

描述（申请人提供）：儿科临床和发育药理学机构国家研究服务奖（T32）的申请要求支持一个新的博士后培训计划，该计划将培训下一代儿科临床研究人员，以承担开发创新，高影响力的临床和发育药理学相关方法，将改善儿童药物的正确使用，以加强儿科治疗和儿童的相关健康结果。许多用于儿童的药物尚未经过儿科人群使用的科学评估，并且未经许可或以标签外方式使用。此外，专门用于治疗儿童疾病的药物很少。辛辛那提儿童医院医学中心（CCHMC）的儿科临床和发育药理学研究培训计划（PCDP-RTP）专门针对这一关键需求而设计。该项目位于儿科临床药理学部门，该部门是儿科系和辛辛那提大学医学院的联合单位。这个T32儿科临床和发育药理学研究培训计划还涉及与詹姆斯L。温克尔药学院和辛辛那提大学药理学、细胞生物物理学和数学科学系。PCDP-RTP的教师顾问来自儿科系的12个部门和辛辛那提大学的四个部门。教师在与儿科疾病领域的临床，转化和基础科学研究相关的一系列领域拥有专业知识，包括依从性，生物信息学，生物标志物开发，生物统计学和流行病学，比较有效性，临床结果，临床试验，流行病学，遗传学/基因组学和基因表达，临床和发育药理学，质量改进和系统生物学/药理学。T32培训计划具有创新性，并且与计划公告中概述的目标保持一致，因为：1）通过与所有主要儿科亚专业的持续研究合作，它专注于多个和不同儿科人群的早期和后期研究; 2）涉及创新定量方法的应用和开发，如基于生理学的PK/通过我们的多学科药理学核心进行PD建模和模拟以及疾病进展分析; 3）通过个性化医学和遗传药理学计划嵌入机构和学术健康中心的药物遗传学/基因组学研究工作; 4）与生物统计学和流行病学，生物信息学以及卫生服务和成果研究紧密结合; 5）可以依靠十多年的经验作为NICHD儿科药理学研究单位网络的13个站点之一。对受训人员的支助通常为两年，但也可提供额外的支助，特别是如果这将使他们在以后建立独立的研究事业方面更具竞争力。PCDP-RTP得到了辛辛那提大学学术健康中心核心设施和各种学术项目的大力支持，该中心包括CCHMC、UCCOM、James L.温克尔药学院和其他几所联盟学院。我们相信，PCDP-RTP提供了一个独特的资源，将打开一个重要的新途径，以扩大人才库的年轻临床研究人员的职业兴趣在儿科治疗。拟议的培训计划将使他们能够获得一个完善的愿景，将临床和发育药理学的最先进原则应用于健全的临床研究和循证临床实践，以改善儿科健康结果。 公共卫生相关性：T32儿科临床和发育研究培训计划将通过培训下一代儿科临床研究者，为扩大和改善目前非常小的儿科临床药理学家库提供出色的资源，以在开发创新，高影响力的临床和发育药理学相关方法方面发挥领导作用，这将改善儿童药物的正确使用。这将进一步增强个性化儿科治疗，并最终提高儿童的护理质量和相关健康结果。

DESCRIPTION (provided by applicant): This application for an institutional National Research Service Award (T32) in Pediatric Clinical and Developmental Pharmacology requests support for a new postdoctoral training program that will train the next generation of pediatric clinical investigators to assume leadership roles in developing innovative, high impact clinical and developmental pharmacology related approaches that will improve proper use of medicines in children to enhance pediatric therapeutics and related health outcomes of children. Many medicines used in children have not been scientifically evaluated for use in the pediatric population and are either used unlicensed or in an off-label manner. In addition, few medicines are developed specifically to treat childhood diseases. The Pediatric Clinical and Developmental Pharmacology Research Training Program (PCDP-RTP) at Cincinnati Children's Hospital Medical Center (CCHMC) is designed specifically to address this critical need. The program is based in the Division of Pediatric Clinical Pharmacology, which is jointly a unit within the Department of Pediatrics and in the University of Cincinnati, College of Medicine. This T32 Pediatric Clinical and Developmental Pharmacology Research Training Program also involves strong collaborations with the James L. Winkle College of Pharmacy and the Departments of Pharmacology & Cell Biophysics and Mathematical Sciences at the University of Cincinnati. Faculty advisors for the PCDP-RTP come from 12 divisions within the Department of Pediatrics and four Departments at the University of Cincinnati. Faculty have expertise in an array of fields relevant to clinical, translational and basic science research of pediatric disease areas that include adherence, bioinformatics, biomarker development, biostatistics and epidemiology, comparative effectiveness, clinical outcomes, clinical trials, epidemiology, genetics/genomics and gene expression, clinical and developmental pharmacology, quality improvement, and systems biology/pharmacology. The T32 training program is innovative and well aligned with the objectives outlined in the program announcement because: 1) it has a focus in early and later phase studies in multiple and diverse pediatric populations through ongoing research collaborations with all major pediatric subspecialties; 2) involves the application and development of innovative quantitative methodologies such as physiologically based PK/PD modeling and simulation and disease progression analysis through our multidisciplinary Pharmacometrics Core; 3) is embedded in the institutional and Academic Health Center's pharmacogenetic/genomics research endeavors through the Personalized Medicine and Genetic Pharmacology Programs; 4) is closely integrated with biostatistics and epidemiology, bio-informatics, and health services and outcomes research; 5) can rely on over ten years of experience as one of 13 sites of the NICHD Pediatric Pharmacology Research Unit Network. The typical period of support for trainees will be two years, though an additional period of support may be provided, especially if it will make them more competitive for subsequently establishing an independent research career. The PCDP-RTP is well supported by core facilities and a variety of academic programs at the University of Cincinnati's Academic Health Center, which includes CCHMC, UCCOM, the James L. Winkle College of Pharmacy and several other allied colleges. We believe that the PCDP-RTP provides a unique resource that will open an important new avenue to enlarge the pool of talented young clinical investigators with a career interest in pediatric therapeutics. The proposed training program will allow them to acquire a refined vision for applying state of the art principles of clinical and developmental pharmacology to sound clinical research and evidence-based clinical practice to improve pediatric health outcomes. PUBLIC HEALTH RELEVANCE: The T32 Pediatric Clinical and Developmental Research Training Program will provide an outstanding resource for expanding and improving the current critically small pool of pediatric clinical pharmacologists by training the next generation of pediatric clinical investigators to assume leadership roles in developing innovative, high impact clinical and developmental pharmacology related approaches that will improve proper use of medicines in children. This will allow the further enhancement of personalized pediatric therapeutics and ultimately improve the quality of care and related health outcomes of children.