Cincinnati Training Program in Pediatric Clinical and Developmental Pharmacology

描述(由申请人提供)：本申请机构国家研究服务奖(T32)在儿科临床和发展药理学，请求支持一个新的博士后培训计划，将培训下一代儿科临床研究人员在开发创新的，高影响的临床和发展药理学相关的方法，将改善儿童的药物正确使用，以提高儿童的治疗和相关的健康结果的领导作用。儿童使用的许多药物没有经过儿科人群使用的科学评估，要么未经许可使用，要么以标签外的方式使用。此外，专门治疗儿童疾病的药物很少。辛辛那提儿童医院医学中心(CCHMC)的儿科临床和发展药理学研究培训计划(PCDP-RTP)就是专门为满足这一关键需求而设计的。该计划的基础是儿科临床药理学分部，该分部是儿科和辛辛那提大学医学院的一个联合单位。这项T32儿科临床和发展药理学研究培训计划还包括与詹姆斯·L·温克尔药学院以及辛辛那提大学药理学、细胞生物物理学和数学科学系的密切合作。PCDP-RTP的教师顾问来自辛辛那提大学儿科系的12个部门和4个系。教师拥有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的专业知识，包括依从性、生物信息学、生物标记物开发、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培训计划是创新的，并与计划公告中概述的目标很好地保持一致，因为：1)它通过与儿科所有主要亚科的持续研究合作，专注于多个和不同儿科人群的早期和后期研究；2)通过我们的多学科药物计量学核心，应用和开发创新的量化方法，如基于生理的PK/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；4)与生物统计学和流行病学、生物信息学、健康服务和结果研究紧密结合；5)作为NICHD儿科药理学研究单位网络的13个站点之一，可以依靠十多年的经验。对受训人员的一般支持期限为两年，但可能会提供额外的支持期限，特别是如果这将使他们在随后建立独立研究事业方面更具竞争力的话。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良好支持，该中心包括CCHMC、UCCOM、詹姆斯·L·温克尔药学院和其他几个联合学院。我们相信，PCDP-RTP提供了一种独特的资源，将开辟一条重要的新途径，扩大对儿科治疗学有职业兴趣的有才华的年轻临床研究人员的队伍。拟议的培训计划将使他们获得一个精致的愿景，将最先进的临床和发展药理学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。

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.