CLINICAL INVESTIGATOR TRAINING ENHANCEMENT: CITE PROGRAM

虽然目前美国数以千计的临床医生-科学家由个人或机构培训拨款资助，但由于这些受训人员往往分散在大学内不同的部门、系和学校，因此往往没有提供全面的教学研究课程。我们建议为致力于临床研究事业的博士后实习生提供一个为期两年的正式计划，名为临床研究人员培训强化计划(CITE)。主要目标是：(1)制定和实施为期两年的正式临床研究课程，包括开发4门新课程，提供临床研究方法、生物统计学、流行病学、研究伦理、临床试验、转化研究、科学写作和拨款准备方面的培训；(2)创建指导有效性增强计划；(3)为CITE注册学生制定新的临床研究硕士学位计划；(4)制作课程产品(网站；音频；视频)供本地使用和传播。印第安纳大学(IU)在实现这些目标方面的优势包括：在过去3年中完成的研究课程的重要前期工作，从50个培训补助金和职业奖项中提取的大量潜在参与者，72名参与其中的教职员工和导师，拥有大量外部资金组合，一个已资助超过35年的综合临床研究中心，大量多样化的患者群体，以及印第安纳大学医学院、护理和牙科学院在这项提案中的合作伙伴关系。学员将修读8门必修课，并可选修自己感兴趣领域的其他选修课，以获得临床研究硕士学位。除了一名主要导师外，每个学员都将有一个正式的导师小组，大约每4个月召开一次会议，并根据明确的基准监测进展情况，包括两份手稿和一份在两年期计划结束前提出的拨款建议。将制定教学大纲，以书面形式和专门网站进行传播。此外，还将以录音带和录像带的形式提供课程的部分内容。印第安纳大学Cite计划的成果将是职业临床研究人员的定期产出，在各种媒体上提供的8个组成部分的课程，它在我们自己的机构之外是有用的，以及在指导临床研究方面的创新，将具有广泛的适用性。

While thousands of clinician-scientists in the U.S. are currently funded by individual or institutional training grants, a comprehensive didactic research curriculum is often not provided since such trainees are often scattered through separate divisions, departments and schools within the university. We propose a 2-year formal program for postdoctoral trainees committed to a career in clinical research, entitled the Clinical Investigator Training Enhancement (CITE) Program. The major aims are to: (1) Develop and implement a 2-year formal clinical research curriculum, including development of 4-new courses, to provide training in clinical research methods, biostatistics, epidemiology, research ethics, clinical trails, translational research, scientific writing, and grant preparation; (2) Create a mentoring effectiveness enhancement program; (3) Develop a new Masters of Clinical Research degree program for CITE enrollees; (4) Produce curricular products (website; audio; video) for both local use and dissemination. Strengths of Indiana University (IU) in achieving these aims include important preliminary work on research curricula done over the past 3 years, a large pool of potential participants drawn from 50 training grants as well as career awards, 72 participating faculty and mentors with a large portfolio of extramural funding, a General Clinical Research Center that has been funded for over 35 years, a large diverse patient population, and partnership in this proposal by IU's Schools of Medicine, Nursing and Dentistry. Participants will take 8 required courses with the option for other elective courses in their area of interest leading to a Masters of Clinical Research Degree. In addition to a primary mentor, each trainee will have a formal Mentor Panel that meets approximately every 4 months and monitors progress according to explicit benchmarks, including two manuscripts and one grant proposal by the end of the 2-year program. Syllabi will be developed for dissemination in both written form as well as a special website. Also selected components of the curriculum will be made available in audiotaped and videotaped formats. Outcomes of the Indiana University CITE Program will be regular output of career clinical researchers, an 8-component curriculum available in various media that is useful beyond our own institution, and innovations in mentoring clinical research that will have broad applicability.