Graduate School of Arts and Sciences Bulletin of Yale University
 
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Investigative Medicine

Department of Medicine
Edward S. Harkness Building (ESH), basement 18–20, 785.6842
http://info.med.yale.edu/invmed/
Ph.D.

Director of Graduate Studies
Joseph Craft (invmed@info.med.yale.edu)

Deputy Director
Eugene Shapiro

Professors
Karen Anderson (Pharmacology), Henry Binder (Internal Medicine; Cellular & Molecular Physiology), Joseph Craft (Internal Medicine; Immunobiology), Thomas Gill (Internal Medicine; Epidemiology; Investigative Medicine), Fred Gorelick (Internal Medicine; Cell Biology), Jeffrey Gruen (Pediatrics; Genetics ;Investigative Medicine), Harlan Krumholz (Internal Medicine; Epidemiology; Investigative Medicine), Eugene Shapiro (Pediatrics, Epidemiology; Investigative Medicine), George Tellides (Surgery; Investigative Medicine), Mary Tinetti (Internal Medicine, Epidemiology; Investigative Medicine)

Affiliated Professors
James Dziura (Internal Medicine; Pediatrics), David Fiellin (Internal Medicine), William Philbrick (Internal Medicine)

Fields of Study

The Investigative Medicine Program offers a special 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:

  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 who 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 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.

Special Requirements for the Ph.D. Degree

The minimum overall course requirements for the doctorate program are nine (9) courses. Full-time 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. 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 which 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 required curriculum for each program of study is as follows:

Course Requirements for Laboratory-Based Patient-Oriented Research

1. IMED 615 Functional Genomics in Translational Research
2. IMED 625 Principles of Clinical Research
3. IMED 630 Ethical and Practical Issues in Clinical Investigation
4. IMED 635 Directed Reading in Investigative Medicine
5. IMED 645 Introduction to Biostatistics in Clinical Investigation
6. IMED 655 Grants, NIH, and Manuscripts
7. IMED 680 Topics in Human Investigation
8. CBIO 601 Molecular and Cellular Basis of Human Disease (spring and fall)
9. Elective

Course Requirements for Clinically Based Patient-Oriented Research

1. IMED 630 Ethical and Practical Issues in Clinical Investigation
2. IMED 635 Directed Reading in Investigative Medicine
3. IMED 655 Grants, NIH, and Manuscripts
4. IMED 660 Methods in Clinical Research (summer)
5. IMED 661 Methods in Clinical Research (fall)
6. IMED 662 Methods in Clinical Research (spring)
7. IMED 680 Topics in Human Investigation
8. Elective
9. Elective

Courses

IMED 615a, Functional Genomics in Translational Research.  Joseph Craft.
MTWThF 2–5
In this two-week course, students learn how to access and interpret the vast amounts of genetic and genomic data that are rapidly being accumulated from genome sequencing projects. This course takes an integrated approach exploring how genomes are mapped and sequenced, how various computational methods convert this raw data into biologically relevant information, and how this information can then be utilized to design experimental approaches to gene function. Lectures are supplemented with computer laboratory sessions to reinforce ideas and to provide practical experience. The course provides practical training in bioinformatics methods, including accessing the major public sequence databases, use of the BLAST tools to find and compare sequences, analysis of protein and nucleic acid sequence motifs, gene structure and promoter analysis, sequence alignment and comparative genomics. Experimental approaches covered include PCR, real-time quantitative PCR, primer design, microarray, inhibitory RNA, and the design of transgenic and knockout mouse models. Consent of instructor required. Two weeks, August 13–August 24.

IMED 625a, Principles of Clinical Research.  Eugene Shapiro.
MTWThF 2–4
The purpose of this intensive two-week course is to provide an overview of the objectives, research strategies, and methods of conducting 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 required. Two weeks, July 30–August 10.

IMED 630a, Ethical and Practical Issues in Clinical Investigation.  Henry Binder.
T 3.30–5
This term-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. Format consists of didactic presentation followed by discussion. Consent of instructor required.

IMED 635a or b, Directed Reading in Investigative Medicine.  Joseph Craft.
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.

IMED 645a, Introduction to Biostatistics in Clinical Investigation.  Henry Binder.
MTWThF 8.30–11
This 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 16–27.

IMED 650a, Seminars in Clinical Investigation.  Eugene Shapiro.
W 2–4
In this term-long seminar course a range of topics is covered in the format of an interactive seminar. Topics including detailed evaluation of study designs (cohort studies, case-control studies, and clinical trials), development and validation of indices, review of approaches to methodology and issues related to implementation of the methodology (assuring quality of the data, qualitative research methods, estimation of sample size and statistical power), and introduction to finding sources to fund grant proposals. The format for most of the seminars consists of a didactic presentation followed by intensive discussion of research articles and research protocols. Students lead the discussion in the critical analysis and evaluation of the articles. Attendance and active participation are required. Consent of instructor required.

IMED 655b, Grants, NIH, and Manuscripts.  Eugene Shapiro.
W 2–4
In this term-long course, students gain intensive, practical experience in evaluating and preparing grants, 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-23 or a K-08 grant). Attendance and active participation are required. Consent of instructor required.

IMED 660a, Methods in Clinical Research, Part I.  Eugene Shapiro.

IMED 661a, Methods in Clinical Research, Part II.  Eugene Shapiro.

IMED 662b, Methods in Clinical Research, Part III.  Eugene Shapiro.
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 health policy. Consent of instructor required.

IMED 680b Topics in Human Investigation.  Joseph Craft, Karen Anderson.
This 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. The latter section also includes a discussion of the FDA approval process.

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