Clinical Researach Curriculum Award

描述（由申请人提供）： 临床流行病学和生物统计学中心（CCEB）、伦纳德戴维斯研究所（LDI）和宾夕法尼亚大学医学院实验治疗中心（CET）提交了更新创新和综合临床研究培训计划的申请，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）的学员，谁是从那些有兴趣在学术临床研究的职业作为独立的调查员中选择，可以在临床流行病学（MSCE）或科学的新硕士转化研究（MTR）学位课程注册。 这两个项目的核心课程包括研究方法，生物统计学和生物伦理学课程。此外，一个介绍性的纵向以患者为导向的研究（POR）课程和一系列介绍性的临床研究方法课程提供给初级教师，居民和研究员，他们的研究兴趣仍然是新兴的。 MCE和MTR课程都是2 - 3年的全日制课程，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的共享课程，沿着科学写作和联邦人类受试者研究政策和法规的培训，以及独立研究项目的开发和完成。 长期的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。 在最初的CRCA的支持下，该计划得到了极大的扩展和改进，现在包括五个轨道：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学位课程最近在最初的CRCA提供的支持下开发，强调基于机制的转化研究，旨在培养训练有素的研究人员，将实验室研究结果应用于患者，进行人体生理学和疾病研究机制。 POR和介绍性临床研究方法课程，开发和/或由最初的CRCA提供的支持下扩大，寻求招募有前途的初级教师，居民和研究员进入以患者为导向的研究领域。 涵盖介绍性临床研究方法和主题的学期和夏季短期课程，在2003 - 04年首次提供，旨在向教师，居民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，法规事务和药物审批过程的基本机制。 拟议方案的优势是医学院在国家卫生研究院支持的临床研究和培训方面的卓越记录;对临床研究专业知识发展的机构重视和支持;为学员提供全面的课程和培训选择;以及CCEB、LDI和CET之间已经形成的合作联系;一个杰出的，多学科的教师组成的高度承诺和成功的独立的临床研究人员和导师;和最初的CRCA证明成功。 此外，拟议的计划受益于NIH资助的一般临床研究中心（GCRC），CCEB，LDI和CET广泛使用的综合资源的可用性。 额外的资源包括广泛的和新开发的实验室，大型数据库可用于研究项目，一系列专门的分析能力，以及承诺，专业知识，以及主要研究者和共同主要研究者在流行病学，卫生服务研究和基于机制的研究中的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.