Clinical Pharmacology Training Program

临床药理学培训项目

• 批准号: 10206154
• 负责人: WALTER K KRAFT
• 金额: $ 78.34万
• 依托单位: THOMAS JEFFERSON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-07-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10206154
• 关键词: Clinical Pharmacology; Training Programs

PROJECT SUMMARY/ABSTRACT This is a proposal to continue the evolution of postdoctoral training in clinical pharmacology as a collaborative program in pediatric and adult therapeutics in the joint program between Thomas Jefferson University (TJU) with the Children’s Hospital of Philadelphia (CHOP). The goal is to realize one key objective of the NIGMS-NICHD collaboration in clinical pharmacology as a leading joint program training clinician investigators to translate novel discoveries into therapeutic paradigms that transform disease management for children and adults. The program is designed for eight postdoctoral fellows, including MDs and MD-PhDs, and PharmDs, focused on human pharmacology and therapeutics. While training integrates therapeutics across the developmental continuum for fellows, half pursue careers in pediatric and half in adult clinical pharmacology to address shortages in these communities of practice nationally. The program, which is two years with the potential to extend for a third year, expands a well-established curriculum of didactic coursework, conferences, and rotations (20% effort) and research (80% effort). The breadth of pediatric and adult clinical pharmacology is delivered using a framework built on the TJU Training Program in Human Investigation (former NIH K30 Program). Courses cover clinical pharmacology, clinical trials design, statistics, pharmacoepidemiology, pharmacometrics, drug development, ethics, management, leadership, grant writing and presentation skills. Advanced training in academic and industrial pharmacometrics is an elective offering. Conferences include journal club in human therapeutics, research ethics, and seminars in human therapeutics. Rotations provide experience in the critical analysis of the scientific literature on the editorial board of the Annals of Internal Medicine; critical review of pediatric (CHOP) and adult (TJU) human subjects research on institutional review boards (IRBs); clinical trial execution in the TJU Clinical Research Unit; special issues in pediatric therapeutics on the CHOP formulary and investigational new drug (IND) committees, or analytic method development to support trainee pharmacokinetic studies. Fellows customize their education by selecting electives congruent with career aspirations, including drug development at Merck and/or rotation at the Food and Drug Administration (FDA). The majority of fellows’ time is focused on independent, hypothesis-driven research. Opportunities in pediatric and adult experimental therapeutics are offered by 54 preceptors representing 9 broad areas of distinction, including cancer, cardiopulmonary medicine, neurosciences, virology and immunology, connective tissue biology, pediatric oncology, systems and clinical pharmacology, gastroenterology, and pediatric therapeutics. Preceptors are selected based on their productive research programs related to therapeutics, training success, and commitment to train fellows. This program will continue to build upon an exemplary record of recruiting qualified diverse trainees who have been uniformly successful in academia, the biopharmaceutical industry, and FDA.

项目总结/摘要 这是一个建议，继续在临床药理学博士后培训的发展，作为一个合作 托马斯杰斐逊大学（TJU）与 费城儿童医院（CHOP）目标是实现NIGMS-NICHD的一个关键目标 临床药理学合作作为一个领先的联合计划培训临床研究人员翻译小说 将新发现转化为治疗范式，改变儿童和成人的疾病管理。程序 是专为八个博士后研究员，包括医学博士和医学博士，和药学博士，重点是人类 药理学和治疗学。虽然培训整合了整个发展连续体的治疗方法， 研究员，一半追求事业在儿科和成人临床药理学的一半，以解决这些短缺， 全国实践社区。该计划为期两年，有可能延长到第三年， 扩展教学课程、会议和轮换（20%的努力）的完善课程， 研究（80%的努力）。儿科和成人临床药理学的广度是使用一个框架交付 TJU人类调查培训计划（前NIH K30计划）。课程涵盖临床 药理学，临床试验设计，统计学，药物流行病学，药物计量学，药物开发， 道德、管理、领导能力、赠款写作和演讲技巧。高级学术培训和 工业药物计量学是选修课程。会议包括人类治疗学杂志俱乐部， 研究伦理和人类治疗学研讨会。轮换提供了批判性分析的经验， 内科学年鉴编辑委员会的科学文献;儿科学的评论 在机构审查委员会（IRB）上进行的CHOP（CHOP）和成人（TJU）人类受试者研究;临床试验执行 在TJU临床研究单位;特殊问题的儿科治疗的CHOP处方集和 研究性新药（IND）委员会或分析方法开发，以支持受训者的药代动力学 问题研究研究员通过选择与职业抱负一致的选修课来定制他们的教育，包括 默克公司的药物开发和/或美国食品药品监督管理局（FDA）的轮换。大多数研究员 时间集中在独立的，假设驱动的研究。在儿科和成人实验中的机会 治疗方法由54位导师提供，代表9个广泛的领域，包括癌症， 心肺医学、神经科学、病毒学和免疫学、结缔组织生物学、儿科 肿瘤学、系统和临床药理学、胃肠病学和儿科治疗学。Preceptors是 根据他们与治疗、培训成功和承诺相关的生产性研究计划进行选择 训练伙伴该计划将继续建立在招募合格的多样化的模范记录 在学术界、生物制药行业和FDA取得一致成功的学员。