Investigative Medicine

2 Church Street South, Suite 112, 203.785.7467
http://medicine.yale.edu/investigativemedicine
Ph.D.

Director of Graduate Studies
Joseph Craft (joseph.craft@yale.edu)

Deputy Director
Eugene Shapiro

Professors Karen Anderson (Pharmacology), Joseph Craft (Internal Medicine; Immunobiology), David Fiellin (Internal Medicine; Epidemiology), Thomas Gill (Internal Medicine; Epidemiology), Fred Gorelick (Internal Medicine; Cell Biology), Jeffrey Gruen (Pediatrics; Genetics), Harlan Krumholz (Internal Medicine; Epidemiology), Chirag Parikh (Internal Medicine), Eugene Shapiro (Pediatrics; Epidemiology), George Tellides (Surgery), Mary Tinetti (Internal Medicine; Epidemiology)

Fields of Study

The Investigative Medicine program offers a training pathway for highly select physicians in clinical departments who are interested in careers in clinical research. The program is designed to develop a broad knowledge base, analytical skills, creative thinking, and the hands-on experience demanded of clinical researchers devoted to disease-oriented and patient-oriented investigation. The program provides the student with individualized experience encompassing formal course work and practical experience, under the supervision and mentorship of a senior faculty member.

Students will enter the program with a broad range of experience and interests. Students can undertake thesis work in a variety of disciplines. These include but are not limited to:

  1. Evaluating risk factors and interventions for disease using modern concepts in quantitative methods and clinical study design.
  2. Investigating the biochemical, physiologic, and genetic basis of disease in the setting of a Clinical Research Center.
  3. Exploring the molecular basis of a disease from the laboratory standpoint.

Special Admissions Requirements

The Investigative Medicine program is designed for students with an M.D. or D.O. degree. To be eligible for admission, applicants must have completed two or more years of postgraduate clinical training. Prospective students who are already in a residency or subspecialty clinical fellowship program at Yale may apply to the Investigative Medicine program anytime during the first two years of that training (approximate). Application to the program also may be made concurrently with application for residency or fellowship training in a clinical department at the Yale School of Medicine. Special arrangements will be made for a deferred acceptance by the Graduate School.

The most important criteria for selection into the program are commitment to rigorous training in clinical investigation and evidence of high academic achievement in undergraduate and medical school courses, and on scores from the USMLE. All applicants must be eligible to practice medicine in the United States.

Special Requirements for the Ph.D. Degree

The minimum overall course requirements for the doctorate program are completion of nine (9) courses. Intensive course work will extend for twelve months, starting in July. The majority of the course requirements are to be completed by the end of the first year of study. Prior to registering for a second year of study, students must successfully complete IMED 630, Ethical Issues in Biomedical Research. In addition to IMED 655, electives are often taken in the second year, with the expectation that they be completed by the end of the second year. To be eligible to take the comprehensive qualifying examination, students must achieve the grade of Honors in two courses (one course if a full-year course), have a minimum grade average of High Pass, and have completed a minimum of six courses. When requirements are met (typically by December 31 of the second year), students submit their thesis proposal and undertake the comprehensive qualifying examination. In order to be admitted to candidacy, students must pass both the written and oral comprehensive qualifying examinations and submit a thesis prospectus that has been approved by their qualifying committee. The remaining degree requirements include completion of the dissertation project, writing of the dissertation, and its oral defense. It is expected that most students will complete the program in three to five years. There is no foreign language requirement. The minimum required curriculum for each program of study is as follows:

Course Requirements for Laboratory-Based
Patient-Oriented Research

IMED 625, Principles of Clinical Research

IMED 630, Ethical Issues in Biomedical Research

IMED 635, Directed Reading in Investigative Medicine

IMED 645, Introduction to Biostatistics in Clinical Investigation

IMED 655, Writing Your Career Development (K-type) Grant or IMED 670, Writing Your First Independent Investigator-Initiated (R-type) Grant

IMED 680, Topics in Human Investigation

CBIO 601, Frontiers

CB&B 740, Clinical and Translational Informatics

Elective (1)

Course Requirements for Clinically Based
Patient-Oriented Research

IMED 630, Ethical Issues in Biomedical Research

IMED 635, Directed Reading in Investigative Medicine

IMED 655, Writing Your Career Development (K-type) Grant or IMED 670, Writing Your First Independent Investigator-Initiated (R-type) Grant

IMED 660, Methods in Clinical Research, Part I

IMED 661, Methods in Clinical Research, Part II

IMED 662, Methods in Clinical Research, Part III

IMED 680, Topics in Human Investigation

Electives (2)

Courses

IMED 625a, Principles of Clinical ResearchEugene Shapiro and David Fiellin

The purpose of this intensive two-week course is to provide an overview of the objectives, research strategies, and methods of conducting patient-oriented clinical 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. Two weeks, July 23–August 4, 2018. Permission of instructor required.
MTWThF 2pm-4pm

IMED 630a, Ethical Issues in Biomedical ResearchJoseph Craft

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.
T 3:30pm-5pm

IMED 635a, Directed Reading in Investigative MedicineStaff

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. Four sessions are required; dates/times by arrangement. Consent of instructor required.
HTBA

IMED 645a, Introduction to Biostatistics in Clinical InvestigationEugene Shapiro

The course provides an introduction to statistical concepts and techniques commonly encountered in medical research. Previous course work in statistics or experience with statistical packages is 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 incorporates lecture content into practical application by introducing the statistical software package SPSS to describe and analyze data. Two weeks, July 9–July 20, 2018. Consent of instructor required.
MTWThF 8:30am-11:15am

IMED 655b, Writing Your Career Development (K-type) GrantEugene Shapiro

In this term-long course, students 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 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 for a K-type mentored career development award. Attendance and active participation are required. There may be spaces to audit the course. Consent of instructor required.
W 1pm-3pm

IMED 660a, Methods in Clinical Research, Part IEugene Shapiro

This yearlong course (with IMED 661 and 662), 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 participatory research, and health policy. Consent of instructor required.
HTBA

IMED 661a, Methods in Clinical Research, Part IIEugene Shapiro

This yearlong course (with IMED 660 and 662), 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 participatory research, and health policy. Consent of instructor required.
HTBA

IMED 662b, Methods in Clinical Research, Part IIIEugene Shapiro

This yearlong course (with IMED 660 and 661), 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 participatory research, and health policy. Consent of instructor required.
HTBA

IMED 670b, Writing Your First Independent Investigator-Initiated (R-type) GrantEugene Shapiro

In this term-long course, students gain intensive, practical experience in evaluating and preparing grant proposals, including discussion of NIH study section format. The course is particularly designed to help investigators in the “K to R” transition period. The course is limited to students who plan to submit an R-type (e.g., R01 or R21) grant, as well as VA and foundation grant proposals. Attendance and active participation are required. Consent of instructor required.
W 3pm-5pm

IMED 680b / B&BS 680b, Topics in Human InvestigationJoseph Craft

The course teaches 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 according to the FDA approval process. The first component describes aspects of structure-based drug design and offers insight into how the drug discovery process is conducted in the pharmaceutical industry. The format includes background lectures with discussions, labs, and computer tutorials. The background lectures include a historical perspective on drug discovery, the current paradigm, and important considerations for future success. The second component of the course provides students with knowledge of the basic tools of clinical investigation and how new drugs are tested in humans. A series of lectures and discussions provides an overview of the objectives, research strategies, and methods of conducting patient-oriented research, with a focus on design of trials to test therapeutics. Each student is required to participate (as an observer) in an HIC review, in addition to active participation in class. Consent of instructor required.
Th 3pm-4:30pm

IMED 900a and IMED 901b, Independent ResearchStaff


HTBA