IMED 625: Principles of Clinical Research
The purpose of this intensive two-week course is to provide an overview of the objectives, research strategies and methods of patient-oriented research. Topics include: competing objectives of clinical research; principles of observational studies; principles of clinical trials; principles of meta-analysis; interpretation of diagnostic tests; prognostic studies, causal inference, qualitative research methods, and decision analysis. Sessions generally combine a lecture on the topic with discussion of articles that are distributed in advance of the sessions. Consent of instructor is required. Course Director: Eugene Shapiro, M.D.
IMED 630: Ethical and Practical Issues in Clinical Investigation
This semester-long course addresses topics that 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, 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 obtain funding for, conduct, and present a clinical study. Satisfactory completion of this course provides credit for Instruction in Responsible Conduct of Research and will satisfy the NIH requirement for such instruction. Format consists of didactic presentation followed by discussion. Consent of instructor is required. Course Director: Henry Binder, M.D.
IMED 635: Directed Reading in Investigative Medicine
An independent study course for first-year students in the Investigative Medicine program. Topics are chosen by the student, and reading lists are provided by faculty for weekly meetings to discuss articles. Six sessions are required; dates/times by arrangement. Consent of instructor required. Course Director: Joseph Craft, M.D.
IMED 645: Introduction to Biostatistics in Clinical Investigation
This course introduces statistical concepts and techniques commonly encountered in medical research. Previous coursework in statistics or experience with statistical packages are not a requirement. Topics to be discussed include study design, probability, comparing sample means and proportions, survival analysis, and sample size/power calculations. The computer lab will incorporate lecture content into practical application by introducing the statistical software package SPSS to describe; analyze data. A personal laptop is required for course. Course has limited enrollment. Consent of instructor required. Course Director: Eugene Shapiro, M.D.
IMED 655: Writing Your First Big Grant Proposal
In this term-long course, students will gain intensive, practical experience in evaluating and preparing grant proposals, including introduction to NIH study section format. The course gives new clinical investigators the essential tools to design and to initiate their own proposals for obtaining grants to do research and to develop their own careers. The course is limited to students who plan to submit grant proposals (usually for either a K-type mentored career development award but also for R-type awards). Attendance and active participation are required. Consent of instructor required. Course Director: Eugene Shapiro, M.D. Co-Director: David Fiellin, M.D.
IMED 660: Methods in Clinical Research, Part I
IMED 661: Methods in Clinical Research, Part II
IMED 662: Methods in Clinical Research, Part III
This yearlong course, presented by the Robert Wood Johnson Clinical Scholars Program, presents in depth the methodologies used in patient-oriented research, including methods in biostatistics, clinical epidemiology, health services research, community-based research, and participatory health policy. Consent of instructor required. The Methods in Clinical Research course(s) is limited to students in the Investigative Medicine Program. Enrollment is this course is limited to students in the Investigative Medicine Program. Course Director: Eugene Shapiro, MD
IMED 680: Topics in Human Investigation
The human investigation course will teach students about the process through which novel therapeutics are designed, clinically tested, and approved for human use. It is divided into two main components, with the first devoted to moving a chemical agent from the bench to the clinic, and the second to outlining the objectives and methods of conducting clinical trials to the FDA approval process. The first component will describe aspects of structure-based drug design and offer insight into how the drug discovery process is conducted in the pharmaceutical industry. The format will include background lectures with discussions, labs, and computer tutorials. Background lectures will include a historical perspective on drug discovery, the current paradigm, and important considerations for future success. The second component of the course will provide students with knowledge of the basic tools of clinical investigation and how new drugs are tested in humans. A series of lectures and discussions will provide an overview of the objectives, research strategies, and methods of conducting patient-oriented research, with a focus upon design of trials to test therapeutics. These sessions are followed by discussion of topics that are central to the conduct of clinical investigation including ethics of, and development of protocols for, human investigation. Practical experience will also be part of these latter sessions, with opportunities for students to observe the Yale Human Investigations Committee and the enrollment of patients in clinical protocols at the General Clinical Research Center or the Pfizer Clinical Research Unit. In the final lectures, clinical trials and data analysis will be discussed in the context of the FDA new drug approval process. Consent of instructor is required. Course Directors: Karen Anderson, Ph.D. and Joseph Craft, M.D.