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Course Descriptions

IMED 625: Principles of Clinical Research
Summer, Either 3rd and 4th week of July, or 4th week of July and 1st week of August. Weekdays, 2:00 - 4:00 PM

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; implementation science; 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. Course has limited enrollment.

Course Director: Eugene Shapiro, M.D.


IMED 630: Ethical Issues in Biomedical Research
Fall Term, Tuesdays, 3:30 - 5:00 PM

This term-long course addresses topics that are central to the conduct of biomedical research, including the ethics of clinical investigation, conflicts of interest, misconduct in research, data acquisition, and protection of research subjects. Practical sessions cover topics such as collaborations with industry, publication and peer review, responsible authorship, and mentoring relationships. Satisfactory completion of this course fulfills the NIH requirement for training in Responsible Conduct of Research. Format consists of lecture presentation followed by discussion. Consent of instructor required.

Course Director: Lauren Ferrante, MD, MHS.


IMED 635: Directed Reading
Fall & Spring Terms, Dates/times by arrangement

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. Enrollment limited to students in the Investigative Medicine PhD Program.

Course Director: Eugene Shapiro, M.D.
Full Course description for IMED 635.


IMED 645: Introduction to Biostatistics in Clinical Investigation
Summer, Either the 1st and 2nd week of July, or the 2nd and 3rd week of July. Weekdays, 8:30 - 11:15 AM

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.

Course Director: Veronika Shabanova, PhD


IMED 655: Writing Your K- or R-type Grant Proposal
Spring Term, Wednesdays, 1:00 - 3:00 PM
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 intended for students who plan to submit grant proposals (for either a K-type career development award or an R-type investigator-initiated award). Attendance and active participation are required. Course has limited enrollment.

Course Director: Eugene Shapiro, M.D. Co-Director: David Fiellin, M.D.


IMED 660: Methods in Clinical Research, Part I
Enrollment limited to students in the Investigative Medicine PhD Program
IMED 661: Methods in Clinical Research, Part II
Enrollment limited to students in the Investigative Medicine PhD Program
IMED 662: Methods in Clinical Research, Part III
Enrollment limited to students in the Investigative Medicine PhD Program


This yearlong course, presented by the National Clinician 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. The Methods in Clinical Research course(s) is limited to students in the Investigative Medicine PhD Program.

Course Director: Eugene Shapiro, MD


Curriculum Summary for Advanced Health Sciences Research Course Participants (Non-Scholars) July 2019 - June 2020


IMED 670: Writing Your K- or R-type Grant Proposal
Spring Term, Wednesdays, 3:00 - 5:00 PM
In this term-long course, students will gain intensive, practical experience in evaluating and preparing grant proposals, including discussion of 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 intended for students who plan to submit grant proposals (for either a K-type career development award or an R-type investigator-initiated award). Attendance and active participation are required. Course has limited enrollment.

Course Director: Eugene Shapiro, M.D. Co-Director: David Fiellin, M.D.


IMED 680: Topics in Human Investigation
Spring Term, Thursdays, 3:00 - 4:30 PM

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 Hospital 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.