Investigative Medicine Program

Background

In 1999, Yale University School of Medicine established a special training program for highly selected fellows in clinical departments who are interested in academic careers in clinical research. This program, called the Investigative Medicine Program, requires a rigorous curriculum of coursework, of mentored research under the tutelage of a clinical faculty member, and of careful supervision by qualifying and thesis committees leading to a Ph.D. degree through the School of Medicine after a 3-5 year period. Trainees may undertake their thesis work in patient-oriented research, laboratory-based research, or a combination (for example utilizing the Clinical Research Centers). Administrative support for this program is provided by the K30 mechanism, by the Dean’s office, and other Medical School and departmental funds. This innovative program is unique among medical schools in the United States, and is bold testimony to the importance in which Yale University School of Medicine holds training of the Physician-Investigator.

The Investigative Medicine Program fulfills the rigorous standards of a doctoral degree awarded by the Graduate School at Yale, while simultaneously addressing the special circumstances of physician-investigators-in-training. This program is located administratively in the Dean’s Office of the medical school and has broad institutional participation through clinical departments including Dermatology, Medicine, Neurology, Pediatrics, Psychiatry, and Surgery. A distinctive feature of the Investigative Medicine Program is its intellectual location in an environment wholly committed to clinical research. A major goal of the program is to attract individuals of high quality who wish to remain connected to their chosen clinical area while acquiring the fundamental tools essential to a successful research career.

Interested students who are not enrolled in the Ph.D. program may attend courses in the Investigative Medicine Program. Application and tuition information are available on the website. Samples of courses of interest to patient-oriented investigators (described below) include:

1. Principles of Clinical Research (intensive 2-week summer course)
2. Seminars in Clinical Investigation (2 semester doctoral course)
3. Practical and Ethical Issues in Clinical Investigation (1 semester course)

Additional course descriptions are available on the website.

Principles of Clinical Research (IMED 625)

The purpose of this 2-week intensive course is to provide an overview of the objectives, research strategies and methods of patient-oriented research. Sample topics will include:

introduction to clinical epidemiology; principles of observational studies; principles of clinical trials; principles of meta-analysis; interpretation of diagnostic tests; prognostic studies; qualitative research; causal inference; decision analysis. Sessions will include lectures and discussion.

Seminars in Clinical Investigation (IMED 650)

This two-semester doctoral level seminar course in patient-oriented research is designed to provide physician investigators with intensive exposure to study methodologies, skills for critical review of the medical literature, and practical experience in designing a research project. This course is designed to provide a practical extension, analogous to a “laboratory course”, for the theoretical grounding provided in the Methods in Clinical Research (MCR) course offered through the Robert Wood Johnson Clinical Scholars Program. A variety of topics are covered in a small-group interactive seminar format, including detailed evaluation of study designs (cohort studies, case-control studies, and clinical trials); development and validation of indices for clinical research, review of methodologic approaches and implementation issues (assuring data quality, qualitative research methods, sample size and power estimation); and development and critique of research protocols. The format for each seminar includes 45-60 minutes of didactic presentation, followed by intensive discussion (60-75 minutes) of research articles selected by the faculty and students. Students lead the discussion in the critical analysis and evaluation of the articles. Occasionally, intensive homework assignments (e.g., sample size calculation) are used in place of critique of articles. In addition, students gain intensive, practical experience in grant writing and reviewing in NIH study section format (in the Spring semester). Attendance and active participation are required. The course gives new clinical investigators the essential tools to design and initiate their own research projects. This course meets weekly (2 hours) for 14 weeks each semester (Fall and Spring). A prerequisite for this course is the summer session of Methods in Clinical Research, an introduction to biostatistics course, or equivalent experience.

Practical and Ethical Issues in Clinical Investigation (IMED 630)

This semester-long course addresses topics which are central to the conduct of clinical investigation, including ethics of clinical investigation, scientific fraud, technology transfer, and interfacing with the pharmaceutical industry. Practical sessions include: scientific presentations and teaching, medical writing, NIH peer review process, journal peer review process, and career development: models of academia. This course provides guidelines and a framework for the clinical investigator to write, obtain funding for, conduct and present a clinical study. Format consists of a lecture followed by discussion.

Contact information—Phone (203) 785-6842

http://info.med.yale.edu/invmed