2008 — 2009 COURSES

IMED 645 INTRODUCTION TO BIOSTATISTICS+                                        Course Fee: $400
July 14 – July 25, 2008                                                                               Registration Deadline: June 20
Lecture, Monday – Friday, 8:30 AM – 10:15 AM
Computer Lab, Monday – Friday, 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 Director: Henry Binder, M.D.    Instructor: James Dziura, Ph.D.

IMED 625  PRINCIPLES OF CLINICAL RESEARCH                                         Course Fee: $350
July 28 – August 8, 2008                                                                              Registration Deadline: July 11
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.

IMED 615  FUNCTIONAL GENOMICS IN TRANSLATIONAL RESEARCH+     Course Fee: $350
August 11 – August 22, 2008                                                                       Registration Deadline: July 25
Monday – Friday, 2:00 PM – 5:00 PM
In this two-week course, students learn how to access and interpret the vast amounts of genetic and genomic data that is 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 will provide 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 & the design of transgenic & knockout mouse models.   + A personal laptop is required for this course. Consent of instructor is required.     Course Director: Joseph Craft, M.D.      Instructor: William Philbrick, Ph.D.

IMED 630 ETHICAL & PRACTICAL ISSUES IN CLINICAL INVESTIGATION     Course Fee: $350
September 2 — December 16, 2008                                                        Registration Deadline: August 15
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                               Course Fee: $350
September 10 — December 17, 2008                                                      Registration Deadline: August 22
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.

IMED 655  GRANTS, NIH AND MANUSCRIPTS                                                     Course Fee: $350
Spring 2009                                                                                                         Registration Deadline: TBA
Day and Time to be Announced
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 is required. Course Director: Eugene Shapiro, M.D.    Course Co-Director: David Fiellin, M.D.

IMED 680  TOPICS IN HUMAN INVESTIGATION                                                Course Fee: $350
Spring 2009                                                                                                        Registration Deadline: TBA
Day and Time to be Announced
This 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. The latter section will also include a discussion of the FDA approval process. Consent of instructor is required.   Course Directors: Karen Anderson, Ph.D. and Joseph Craft, M.D.