Clinical Researach Curriculum Award

临床研究课程奖

• 批准号: 6846475
• 负责人: BRIAN LESLIE STROM
• 金额: $ 30万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-06-01 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6846475
• 关键词: clinical research; curriculum; education evaluation /planning; epidemiology; ethics; experimental designs; health science research potential; interdisciplinary collaboration; longitudinal human study; patient oriented research; postgraduate education; statistics /biometry; training

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.

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学中心 (CCEB)、伦纳德·戴维斯研究所 (LDI) 和实验治疗中心 (CET) 提交了更新创新和综合临床研究培训计划的请求，以支持和进一步发展现有的临床研究培训。 根据职业重点，临床研究课程奖 (CRCA) 学员是从对学术临床研究独立调查员职业感兴趣的学员中选出的，可以报名参加临床流行病学理学硕士 (MSCE) 或新的转化研究理学硕士 (MTR) 学位课程。 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，还为初级教师、住院医师和研究员提供介绍性纵向患者导向研究 (POR) 课程和一系列介绍性临床研究方法课程，这些人员的研究兴趣仍在不断涌现。 MSCE和MTR项目都是2-3年的全日制课程，由核心课程和选修课程组成，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受试者研究政策和法规方面的培训，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，该计划得到了大幅扩展和改进，现在包括五个领域：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学位课程是在最初的CRCA的支持下最近开发的，强调基于机制的转化研究，旨在培养熟练的研究人员，他们接受过培训，将实验室发现应用于患者，进行人体生理学和疾病研究的机制。 POR 和介绍性临床研究方法课程是在最初的 CRCA 提供的支持下开发和/或扩展的，旨在招募有前途的初级教师、住院医师和研究员进入以患者为导向的研究领域。 涵盖临床研究入门方法和主题的学期和夏季短期课程于 2003-04 年首次开设，旨在向教师、住院医师和研究员介绍临床研究。 为期 9 个月的 POR 入门课程概述了生物统计学、试验设计、监管事务以及药物审批流程的机制。 拟议项目的优势在于医学院在 NIH 支持的临床研究和培训方面拥有卓越的记录；机构对临床研究专业知识发展的重视和支持；为学员提供全面的课程和培训选择； CCEB、LDI 和 CET 之间已经建立的合作联系；优秀的多学科教师队伍，由高度敬业且成功的独立临床研究人员和导师组成；以及最初的 CRCA 所取得的成功。 此外，拟议的计划受益于 NIH 资助的普通临床研究中心 (GCRC)，这是 CCEB、LDI 和 CET 广泛使用的综合资源。 其他资源包括广泛的、新开发的实验室、可用于研究项目的大型数据库、一系列专业分析能力，以及首席研究员和联合首席研究员在流行病学、卫生服务研究和基于机制的研究方面的承诺、专业知识和异常互补的跟踪记录。