DESIGN OF A NEW CLINICAL RESEARCH TRAINING PROGRAM

本申请旨在开发临床研究培训计划，以教授设计和开展人类受试者研究所需的技能，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的财团，其中包括来自许多学校，部门，部门，中心和研究所在大学的个人。 我们在大学进行了一项需求调查，这表明我们强烈希望招收具有临床背景的研究员和初级教师参加该计划。与会者对实际操作方法很感兴趣（例如，生物统计学、流行病学）以及与生物伦理学和人类学科有关的课程。 有一个要求，培训时间表，符合更密切地与临床实习生，其轮换为基础的，可变的临床活动往往排除参加标准的学期为基础的课程的时间表。 我们预计在该计划的第一年将招收30名学员。 随着该方案的建立，受训人数可能在以后几年增加。 该计划将设在健康科学高级副校长办公室。该课程由两部分组成：1）一套核心课程，教授临床研究方法和伦理学的概述，并提供生物统计学和测量的良好背景，2）选择六个专业轨道进行深入的集中和重点。 轨道将包括：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。 流行病学及慢性病预防;及6. 翻译研究。 成功完成核心课程的学生将获得证书学位。 完成核心和专业轨道之沿着与论文将导致在临床研究学位MS奖。计划安排课程的替代方法，包括集中块对应于临床轮换，preceptorships，并使用万维网技术的在线课程，让学员上课，以适应他们的时间表，同时仍然保持学员和教师之间的互动。 该计划的所有组成部分将在持续的基础上进行评估。 考虑到大学的资源，教师的热情支持，以及对临床研究培训的明确需求，我们相信将这笔赠款授予匹兹堡大学将大大提高我们培训临床研究人员的能力，并最终增加大学的临床研究。

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.