Clinical Researach Curriculum Award

描述(由申请人提供)： 宾夕法尼亚大学医学院临床流行病学和生物统计中心(CCEB)、伦纳德·戴维斯研究所(LDI)和实验治疗中心(CET)提交了续签创新和综合临床研究培训计划的请求，以支持和进一步发展现有的临床研究培训。根据他们的职业重点，临床研究课程奖(CRCA)的实习生是从那些对学术临床研究的独立研究人员的职业感兴趣的人中挑选出来的，他们可以报读临床流行病学理学硕士(MSCE)或新的翻译研究科学硕士(MTR)学位课程。这两个项目的核心课程都包括研究方法、生物统计学和生物伦理学课程。此外，还为初级教员、住院医生和研究员提供纵向研究入门课程(POR)和一系列临床研究方法入门课程，他们的研究兴趣仍在萌芽之中。 MSCE和MTR项目都是2-3年的全日制项目，包括核心和选修课程，包括研究方法、生物统计学和生物伦理学方面的共享课程，以及科学写作和联邦人类学科研究政策和法规方面的培训，以及开发和完成一个独立的研究项目。长期存在的MSCE学位课程旨在培养训练有素的研究人员，以设计和进行所有类型的正式临床研究研究。在最初CRCA的支持下，该计划得到了实质性的扩展和改进，现在包括五个方面：流行病学、卫生服务研究、人类遗传学、生物伦理学和临床试验。MTR学位课程最近在初始CRCA的支持下开发，强调基于机制的翻译研究，旨在培养熟练的研究人员，他们接受培训，将实验室结果应用于患者进行人类生理学和疾病机制研究。 POR和临床研究方法入门课程在初始CRCA的支持下开发和/或扩展，旨在招募有前途的初级教员、住院医生和研究员进入以患者为中心的研究领域。为期一学期的暑期短期课程，涵盖临床研究方法和主题的介绍，于2003-04年度首次提供，旨在向教师、住院医生和研究员介绍临床研究。为期九个月的POR入门课程概述了生物统计学、试验设计、监管事务和药物审批过程的基本机制。 拟议计划的优势包括：医学院在NIH支持的临床研究和培训方面的卓越记录；机构对临床研究专业知识发展的重视和支持；学员可获得的全面课程和培训选择；CCEB、LDI和CET之间已经建立的合作联系；由高度投入和成功的独立临床研究人员和导师组成的杰出的多学科教员；以及初步CRCA被证明是成功的。此外，拟议的计划还受益于NIH资助的普通临床研究中心(GCRC)的提供，这是一种被CCEB、LDI和CET广泛使用的综合资源。其他资源包括广泛的和新开发的实验室、可用于研究项目的大型数据库、一系列专门的分析能力，以及首席调查员和联合首席调查员在流行病学、卫生服务研究和基于机制的研究方面的承诺、专门知识和异常互补的跟踪记录。

DESCRIPTION (provided by applicant): The Center for Clinical Epidemiology and Biostatistics (CCEB), Leonard Davis Institute (LDI), and Center for Experimental Therapeutics (CET) of the University of Pennsylvania School of Medicine submit this request for the renewal of an innovative and comprehensive clinical research training program, to support and further develop existing training in clinical research. Depending on their career focus, Clinical Research Curriculum Award (CRCA) trainees, who are selected from among those interested in careers as independent investigators in academic clinical research, may enroll in either the Master of Science in Clinical Epidemiology (MSCE) or the new Master of Science in Translational Research (MTR) degree program. The core curriculum for both programs includes courses in research methods, biostatistics, and bioethics. In addition, an introductory longitudinal Patient Oriented Research (POR) course and a series of introductory clinical research methods courses are offered to junior faculty, residents, and fellows, whose research interests still are emerging. Both the MSCE and MTR programs are 2-3 year full time programs consisting of core and elective courses, including shared courses in research methods, biostatistics, and bioethics, along with training in scientific writing and federal human subject research policies and regulations, as well as the development and completion of an independent research project. The longstanding MSCE degree program is designed to produce skilled investigators trained to design and conduct formal clinical research studies of all types. With support from the initial CRCA, this program was substantially expanded and improved and now includes five Tracks: Epidemiology, Health Services Research, Human Genetics, Bioethics, and Clinical Trials. The MTR degree program, developed recently with support provided by the initial CRCA, and which emphasizes mechanism based translational research, is designed to produce skilled investigators who are trained to apply laboratory findings to patients in the conduct of mechanism of human physiology and disease research. The POR and introductory clinical research methods courses, developed and/or expanded with support provided by the initial CRCA, seek to recruit promising junior faculty, residents, and fellows into the fields of patient-oriented research. The semester-long and summer short courses covering introductory clinical research methods and topics, offered for the first time in 2003-04, are designed to introduce faculty, residents, and fellows to clinical research. The nine-month introductory POR course provides an overview of biostatistics, trial design, regulatory affairs, and the mechanics underlying the drug approval process. The strengths of the proposed program are the School of Medicine's exceptional track record of NIH supported clinical research and training; the institutional emphasis on and support for development of expertise in clinical research; the comprehensive course offerings and training options available to trainees; and collaborative links that already have been forged among the CCEB, LDI, and CET; an outstanding, multidisciplinary faculty comprised of highly committed and successful independent clinical investigators and mentors; and the demonstrated success of the initial CRCA. In addition, the proposed program benefits from the availability of the NIH-funded General Clinical Research Center (GCRC), an integrative resource that is used extensively by the CCEB, LDI, and CET. Additional resources include extensive and newly developed laboratories, large databases available for research projects, a range of specialized analytic capabilities, and the commitment, expertise, and unusually complementary track records of the Principal Investigator and co-Principal Investigators in epidemiology, health services research, and mechanism-based research.