DESIGN OF A NEW CLINICAL RESEARCH TRAINING PROGRAM

该申请旨在开发一个临床研究培训项目，教授设计和开展人体研究所需的技能，最终目标是增加匹兹堡大学的临床研究人员。我们已经组建了一个多学科联盟，其中包括来自大学许多学院、部门、部门、中心和研究所的个人。我们在大学进行了一项需求调查，结果表明有强烈的意愿招收有临床背景的研究员和初级教师加入这个项目。学生们对实践方法（如生物统计学、流行病学）以及与生物伦理学和人类学科相关的课程非常感兴趣。有一项要求是制定一个更符合临床实习生时间表的培训时间表，因为临床实习生的轮岗、多变的临床活动常常妨碍他们参加标准的学期课程。我们估计在项目的第一年将招收30名学员。随着该计划的建立，受训人员的数量可能会在以后的几年里增加。该项目将在健康科学高级副校长办公室进行。课程由两部分组成：1)一套核心课程，教授临床研究方法和伦理的概述，并提供生物统计学和测量的良好背景；2)选择六个专业方向，深入集中和关注。曲目将包括：1；有效性、结果和质量研究；2. 临床治疗学研究；3. 医学信息学;4. 健康与行为；5. 流行病学与慢性病预防；和6。转化研究。成功完成核心课程将获得证书学位。完成核心课程和其中一个专业课程并完成论文将获得临床研究硕士学位。计划安排课程的替代方法包括与临床轮转相对应的集中模块，指导和使用万维网技术的在线课程，使学员能够根据自己的时间表上课，同时仍保持学员与教师之间的互动。该计划的所有组成部分将在持续的基础上进行评估。鉴于匹兹堡大学的资源、教职员工的热情支持，以及临床研究培训的明确需求，我们相信向匹兹堡大学授予这笔拨款将大大提高我们培训临床研究人员的能力，并最终增加该大学的临床研究。

This application proposes to develop a clinical research training program to teach the skills necessary to design and conduct research with human subjects with the ultimate goal of increasing clinical investigators at the University of Pittsburgh. We have assembled a multi-disciplinary consortium which includes individuals from many schools, departments, divisions, centers and institutes at the University. We performed a needs survey at the University which indicated a strong desire to enroll fellows and junior faculty with clinical backgrounds into this program. There was a high level of interest in hands-on methodology (e.g., biostatistics, epidemiology) and in courses related to bioethics and human subjects. There was a request for a training schedule that conforms more closely with the schedule of clinical trainees, whose rotation-based, variable clinical activities often preclude attending standard semester-based coursework. We estimate that we will enroll 30 trainees during the first year of the program. The number of trainees is likely to increase in later years as the program becomes established. This program will be based in the office of Senior Vice Chancellor for Health Sciences. The curriculum consists of two components: 1) a set of core courses to teach an overview of clinical research methods and ethics as well as provide a sound background in biostatistics and measurement and 2) a selection of six specialty tracks for in-depth concentration and focus. The tracks will include: 1. Effectiveness, Outcomes, and Quality Research; 2. Clinical Therapeutics Research; 3. Medical Informatics; 4. Health and Behavior; 5. Epidemiology and Prevention of Chronic Disease; and 6. Translational Research. The successful completion of the core curriculum win result in a Certificate degree. The completion of the core and one of the specialty tracks along with a thesis will result in the award of a MS in Clinical Investigation degree. Alternative methods of scheduling courses are planned including concentrated blocks corresponding to clinical rotations, preceptorships, and on-line courses using World Wide Web technology to allow the trainees to take classes to fit their schedules while still maintaining interaction among trainees and the faculty. All components of the program will be evaluated on an ongoing basis. Given the resources of the University, the enthusiastic support of the faculty, and a clear cut need for clinical research training, we believe awarding this grant to the University of Pittsburgh will greatly enhance our ability to train clinical investigators and ultimately increase clinical research at the University.