Childrens Mercy Hospital Fellowship Program in Pediatric Pharmacology

描述（由申请人提供）：儿童慈善医院（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，非常适合提供儿科临床/发育药理学方面的综合T32研究奖学金项目。儿科临床药理学的CMH项目是美国最大的（36名成员，包括16名全职教师，其中5名已获得美国临床药理学委员会的认证）和最具生产力的项目，作为该学科的领先项目之一，已经发展出世界级的声誉。卓越的资源（包括师资和设施）和丰富的研究环境产生了几个国际公认的卓越研究领域，包括发育药物基因组学，药代动力学，药效学和早期临床试验设计/执行。这一成功的证据体现在美国国立卫生研究院对项目教师的持续资助，众多被高度引用的同行评审出版物，为大量来自不同背景的博士后学员（包括培训人员共10人，9名医学博士，1名药学博士，5名目前在学术岗位上）提供示范性教育/培训，以及通过nichd赞助的儿科药理学研究单位网络不断领导科学贡献。该项目是美国唯一一个完全致力于儿科临床药理学的项目，已获得美国临床药理学委员会的认可。它最近被采纳为一项价值1200万欧元的欧洲儿科临床药理学倡议（GRIP倡议）的“示范项目”，以发展整个欧洲的儿科临床药理学培训。这个T32申请中提出的项目结合了与儿科临床/发育药理学相关的学科领域的教学和经验培训（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）。所有的教学将由经验丰富的教师（包括临床和基础科学家）完成，他们在各自的学科领域有重要的研究经验。这将通过参加密苏里大学堪萨斯城医学院提供的生物信息学硕士学位课程而得到加强。在3年的总培训期中，所有研究员（与教师导师一起）将完成一项基于实验室（转化），基于临床（I/II期PK/PD试验）和基于药物流行病学的调查；所有这些都将出版。他们向独立的过渡将在第三年通过准备k奖拨款申请来促进。最后，CMH的项目包含一个经过验证的、多输入的方法来评估学员和培训师，以及一个综合的方法来招募来自不同专业、文化和种族背景的研究员。该项目长期以来的卓越记录将为申请人提供儿科临床/发育药理学的示范培训。

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.