Recommended Class: BIOL W3995
http://www.columbia.edu/cu/biology/courses/w3995x/index.htm
David H. Newman, MD
Director of Clinical Research
Mt. Sinai Hospital
Department of Emergency Medicine
Course Description:
This course is designed to introduce students who are interested in medical careers to the goals, nomenclature, principles, and practical reality of clinical research, with an emphasis on the emergency department (ED) setting. The course will focus on terminology, data collection techniques, research design, and basic biostatistical principles. Understanding research and clinical emergency medicine as an avenue to understanding clinical studies and their implications will be emphasized. Group exercises will include design and implementation of two factitious hypothetical studies where funding, time scale, and resource availability will be considered. A mid-term examination will concentrate on terminology, data collection techniques, and a final examination will focus on research design. Basic didactic biostatistics material will be taught primarily for purposes of familiarization and interpretation of research and will be aimed at the non-mathematician (no Math or Statistics pre-requisites). Students will also be required to take part in the Academic Associates research assistant program at St. Luke’s/Roosevelt Hospital ED. This includes two 4-hour shifts per week of ED time in which students will learn how to assist in the execution of clinical research including performing consents, data collection, and database interaction. ED time will be arranged to fit in and around the student’s academic schedule as needed. Additionally, three to five evening practical sessions will cover ongoing individual ED projects in depth, and students will be shown and instructed on basic procedural skills in emergency medicine (lumbar puncture, endotracheal intubation, etc.) as well as shown dynamic and static invasive imaging including ultrasound, CT scans, and others.
Website: Courseworks will be utilized for posting of electronic materials.
Text: TBA. Most relevant reading materials will be handed out. A user-friendly medical dictionary will be helpful.
Reserve Readings: Copies of reading assignments will be handed out and put on reserve.
Lectures: See lecture schedule below. Sporadic evening sessions during the semester, in addition to lectures, will address specific research projects and their related anatomy, physiology, and research methodology, as well as practical and clinical skills. Sessions will be given by Dr. Newman and other emergency medicine and research faculty.
Clinical: Two shifts total per week as a research assistant in the St. Luke’s or Roosevelt Hospital Emergency Department are required. Shift attendance is mandatory. Orientation for shifts will occur early, occasionally during the first week of class; pre-registration is highly recommended.
Exams: Mid-term covering the first half of the course and a final exam emphasizing the final half.
Grading:
Mid-term - 35%
Final - 35%
Participation - 30%
Shift attend. - Variable (missed shift policy to be discussed in class)
Date |
Lecture |
Discussion |
Reading |
Lecture 1 |
Intro/Overview |
Purpose/goals of clinical research |
|
Lecture 2 |
Basic study nomeclature |
Terminology and precision |
Handout |
Lecture 3 |
Data collection techniques |
Research assistant role in the clinical setting |
Handout |
Lecture 4 |
Biostats 1 |
Review/discussion |
Handout |
Lecture 5 |
Institutional Review Board/Biostats 2 |
Federal regulation and subject protection |
Handout |
Lecture 6 |
Midterm |
-- |
-- |
Lecture 7 |
Research Design |
Case reports, surveys, cohort studies |
Handout |
Lecture 8 |
Research Design |
Case-control studies, Randomized controlled trials |
Handout |
Lecture 9 |
Research Design |
Group exercise - design of 2 fictitious studies |
Handout |
Lecture 10 |
Reading studies |
Understanding research (lay vs scientific press) |
Handout |
Lecture 11 |
Peer Review |
Intro to scientific journals, peer review |
Handout |
Lecture 12 |
Final Exam |
-- |
-- |
Class info:
BIOL W3995
with Dr. Newman
Spring 2012
Tuesday, 4:10-6:00 PM
Location TBA