DESIGN OF A NEW CLINICAL RESEARCH TRAINING PROGRAM

这项申请建议开发一个临床研究培训计划，传授设计和进行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联盟，其中包括来自大学许多学校、系、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，我们强烈希望招收有临床背景的研究员和初级教员参加这个项目。与会者对实践方法(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很高的兴趣。有人要求培训时间表更符合临床实习生的时间表，他们以轮换为基础的、可变的临床活动往往不能参加以学期为基础的标准课程。我们估计，在该项目的第一年，我们将招收30名学员。随着该计划的建立，未来几年受训人员的数量可能会增加。该计划将设在负责健康科学的高级副校长办公室。该课程由两部分组成：1)一套核心课程，讲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方面的良好背景；2)选择六个专业轨道，以进行深入的集中和关注。课程将包括：1.有效性、结果和质量研究；2.临床治疗研究；3.医学信息学；4.健康和行为；5.流行病学和慢性病预防；以及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以及一篇论文后，将获得临床调查硕士学位。计划安排课程的替代方法包括与临床轮换相对应的集中分组、导师职位，以及使用万维网技术的在线课程，以使学员能够根据自己的时间表上课，同时仍保持学员和教职员工之间的互动。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对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赠款将极大地增强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.