Childrens Mercy Hospital Fellowship Program in Pediatric Pharmacology

描述(由申请人提供)：儿童慈悲医院(CMH)通过其儿科临床药理学部门，并与杜克大学和费城儿童医院合作，非常适合提供全面的T32儿科临床/发育药理学研究奖学金计划。儿科临床药理学的CMH项目规模最大(n=36名成员，包括16名全职教职员工，其中5人已获得美国临床药理学委员会的认证)，也是美国最有成效的此类项目，已成为该学科领先项目之一的世界级声誉。该项目优秀的资源(包括师资和设施)和丰富的研究环境已经产生了几个国际公认的优秀研究领域，包括发展药物基因组学、药动学、药效学和早期临床试验设计/执行。这一成功的证据体现在NIH对项目教师的持续资助、大量被高度引用的同行评议出版物、为大量来自不同背景的博士后学员(总共10名包括正在培训的人员；9名医学博士、1名药学博士；5名目前处于学术职位的人)提供模范教育/培训，以及通过NICHD赞助的儿科药理学研究单位网络在做出科学贡献方面不断发挥领导作用。该项目是美国唯一一个获得美国临床药理学委员会认可的专门针对儿科临床药理学的项目。它最近被采纳为1200万E.C.计划(GRIP计划)的“示范计划”，以在整个欧洲发展儿科临床药理学培训。这一T32申请中提出的计划结合了与儿科临床/发展药理学(例如，PK、PD、药物基因组学、生物信息学、建模/模拟、药物流行病学、治疗依从性、药物输送系统、临床试验设计)密切相关的学科领域的教学和经验培训。所有教学将由在各自学科领域具有丰富研究经验的有经验的教师(临床和基础科学家)完成(S)。Floor将参加由密苏里大学堪萨斯城医学院提供的生物信息学硕士学位项目，从而加强这一点。在三年的总培训期间，所有研究员(在教师指导下)将完成一项基于实验室(翻译)、临床(I/II期PK/PD试验)和药物流行病学的调查；所有这些都将产生一份出版物。他们将在第三年通过准备K奖拨款申请来促进他们向独立的过渡。最后，CMH的计划包含了一种经过验证的多输入方法来评估受训者和培训者，以及一种全面的方法来招募来自不同专业、文化和种族背景的研究员。该项目长期的优秀记录将为申请者提供儿科临床/发育药理学方面的模范培训。 与公共卫生相关：美国和欧洲的法规现在要求对可能用于儿童的药物进行实际评估；这项任务由受过临床药理学培训的专业人员承担。虽然美国有700多名临床药剂师接受过成人医学培训，但在过去十年中只有20名接受过儿科临床药理学培训。这一差距及其对儿童健康的深刻负面影响，将通过儿童慈悲医院拟议的儿科临床药理学培训计划得到解决；儿童慈悲医院是一家位于密苏里州堪萨斯城的大型学术儿科医疗中心。

DESCRIPTION (provided by applicant): The Children's Mercy Hospital (CMH), through its Division of Pediatric Clinical Pharmacology and with collaboration from both Duke University and the Children's Hospital of Philadelphia, is ideally suited to provide a comprehensive T32 research fellowship program in Pediatric Clinical/Developmental Pharmacology. The CMH program in Pediatric Clinical Pharmacology, the largest (n=36 members which includes 16 full time faculty members, 5 of whom have been certified by the American Board of Clinical Pharmacology) and most productive such program in the U.S., has developed a world-class reputation as one of the leading programs in this discipline. The outstanding resources (both faculty and facilities) and rich research environment of this program has produced several internationally recognized areas of research excellence which include developmental pharmacogenomics, pharmacokinetics, pharmacodynamics, and early phase clinical trial design/execution. Evidence of this success is reflected by sustained funding of program faculty from NIH, numerous highly cited peer-reviewed publications, the provision of exemplary education/training to a large number of postdoctoral trainees (10 total including those in training; 9 MD, 1 PharmD; 5 currently in academic positions) from diverse backgrounds and continuous leadership in making scientific contributions through the NICHD-sponsored Pediatric Pharmacology Research Unit Network. This program is the only one in the U.S. solely dedicated to Pediatric Clinical Pharmacology that has been accredited by the American Board of Clinical Pharmacology. It has been recently adopted as a "model program" for a ,12million E.C. initiative (GRIP initiative) to develop Pediatric Clinical Pharmacology training across Europe. The program proposed in this T32 application combines didactic and experiential training in subject areas germane to Pediatric Clinical/Developmental Pharmacology (e.g., PK, PD, pharmacogenomics, bioinformatics, modeling/simulation, pharmacoepidemiology, treatment adherence, drug delivery systems, clinical trial design). All teaching will be accomplished by experienced faculty (both clinical and basic scientists) who have significant research experience in their subject area(s). This will be augmented by fellow's participation in a M.S. degree program in Bioinformatics offered by the University of Missouri - Kansas City School of Medicine. Over a 3 year total training period, all fellows (with faculty mentors) will complete an investigation that is laboratory-based (translational), clinical-based (phase I/II PK/PD trial) and pharmacoepidemiology-based; all of which will produce a publication. Their transition to independence will be fostered in the 3rd year by preparation of a K-award grant application. Finally, the program at CMH contains a proven, multiple-input method for evaluation of trainees and trainers, and a comprehensive approach for recruiting fellows from diverse professional, cultural and ethnic backgrounds. The longstanding, documented record of excellence of this program will provide applicants with exemplary training in Pediatric Clinical/Developmental Pharmacology. PUBLIC HEALTH RELEVANCE: Regulations in the United States and Europe now require that drugs that have the potential to be used in children actually be evaluated in them; a task undertaken by professionals trained in clinical pharmacology. While there are over 700 clinical pharmacologists trained in adult medicine in the U.S., only 20 have been trained in pediatric clinical pharmacology over the last decade. This disparity, with its profound negative implications for the health of children, will be squarely addressed by proposed pediatric clinical pharmacology training program at the Children's Mercy Hospital; a large academic pediatric medical center located in Kansas City, Missouri.