SPRING 2010 COURSES

IMED 655  WRITING YOUR FIRST GRANT
January 13 - May 5, 2010                                                                                                  Course Fee $350
Wednesdays, 2:00 PM to 4:00 PM                                                            Registration Deadline: January 4
In this term-long course, students will 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.                                Course Director: Eugene Shapiro, M.D.    Course Co-Director: David Fiellin, M.D.

IMED 680 TOPICS IN HUMAN INVESTIGATION
January 13 - May 6, 2010                                                                                                 Course Fee: $350
Thursdays, 3:00 PM to 4:30 PM                                                                Registration Deadline: January 4
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. The 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.

SUMMER 2010 COURSES

IMED 645 INTRODUCTION TO BIOSTATISTICS+
July 2010 — Dates to be Announced                                                                                 Course Fee: $400
Lecture: Mon–Fri, 8:30 AM – 10:15 AM                            Computer Lab: Mon–Fri, 10:30 AM – 11:15 AM
This course provides an introduction to 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.   SPSS Software included in course fee.  +A personal laptop is required for this course. Consent of instructor is required. Course has limited enrollment. Early applicants receive top priority
Course Director: Henry Binder, M.D.    Instructor: James Dziura, Ph.D.

IMED 625  PRINCIPLES OF CLINICAL RESEARCH
July/August 2010 — Dates to be Announced                                                                    Course Fee: $350
Monday – Friday, 2:00 PM – 4:00 PM
The purpose of this two-week intensive 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 include lectures and discussion of readings distributed in advance. Consent of instructor is required.         Course Director: Eugene Shapiro, M.D.       Course Co-Director: David Fiellin, M.D.

FALL 2010 COURSES

IMED 630 ETHICAL & PRACTICAL ISSUES IN CLINICAL INVESTIGATION
September - December 2010                                                                        Tuesdays, 3:30 PM – 5:00 PM
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, 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.  This course also provides instruction in Responsible Conduct of Research required by the NIH. Format consists of didactic presentation followed by discussion. Consent of instructor is required.
Course Director: Henry Binder, M.D.

IMED 650  SEMINARS IN CLINICAL INVESTIGATION
September — December 2010                                                                 Wednesdays, 2:00 PM – 4:00 PM
In this term-long seminar course, a range of topics are 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 is required.
Course Director: Eugene Shapiro, M.D.    Course Co-Director: David Fiellin, M.D.