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.
