Einstein-Montefiore Institute for Clinical and Translational Research
SYLLABUS
“Design and Conduct of Clinical Research”
Winter - Spring 2014- 2015
Time: Tuesdays and Thursdays (beginning December 2), 5:00-6:30 PM
Location:
Block Building (Mazer) Room 526 (unless otherwise noted)
Albert Einstein College of Medicine campus
Course Leaders:
Paul R. Marantz, MD, MPH; email: paul.marantz@einstein.yu.edu; Block/Mazer 517
Patricia Friedmann, MS; email: patricia.friedmann@einstein.yu.edu; Block/Mazer 613
Office hours: By appointment
Course Description
This seminar course aims to introduce students to clinical research with a focus on epidemiology and
study design. The course uses an introductory clinical research text, along with a critical assessment of
papers from the scientific (clinical and epidemiologic) literature, in order to learn about study designs:
their strengths and weaknesses and how such studies are conducted. Topics to be covered include: basic
epidemiology, measures of association, basic statistics, cohort studies, case control studies, clinical trials,
causal inference, and research ethics.
Course Overview
The course will be taught by a team of 2 faculty members. Some classes will involve computer-based
exercises, and will require students to bring their laptops to class. All classes will require advance
preparation and active participation.
Learning Objectives
At the end of the course, students will be able to:
Describe what makes a good research question.
List the major elements of a cohort (and retrospective cohort) study.
Critique a case-control study, and describe alternative designs.
Explain the advantages and disadvantages of specific study designs for specific research questions.
Interpret a randomized trial.
Explain the role of significance testing in clinical research.
Interpret the major measures of association used in epidemiologic research.
Describe the estimates and assumptions involved in sample size determination, and perform simple
calculations.
1
Identify ethical challenges in clinical investigation, and propose solutions to those challenges.
Distinguish between associations and causal connections in etiologic research.
Course Requirements & Grading
The course will be graded “Honors/Pass/Fail”. (As per graduate school regulations, a grade of
“incomplete” may be allowed if absolutely necessary at the discretion of the Professors) We plan to use
a criterion standard for grading: i.e., Honors > 90%, Pass 65-90%, Fail < 65%. However, we reserve the
right to ‘curve’ these cut-points if necessary.
The grade will be determined using the following formula:
 Final examination (in-class; short-answer/short-essay): 70%
 Class participation as determined by faculty (preparation, contribution to discussion): 30%
Final Exam
There will be an in-class final exam.
Angel
Angel will be used as the main platform for posting course materials and communicating with students.
Textbooks
Designing Clinical Research, Hulley SB, Cummings SR, Browner WS, Grady DG, Newman TB., 4th Ed.
Lippincott Williams & Wilkins; Philadelphia: 2013. ISBN-10: 1608318044 | ISBN-13: 978-1608318049
Course calendar; all classes 5:00-6:30 PM (Faculty Key: PF=Patricia Friedmann; PM=Paul Marantz):
All Chapters are from Hulley et al. Other reading assignments will be available on Angel. Other
readings (required and/or recommended) may be added as the course proceeds.
Month
Dec
Tues
2
9
Thurs Faculty Topic
PF/PM The Rise and Fall of
Hormone Therapy
4
Developing a research
question
PF
Sampling and
Recruitment
11
Measurement
16
PF
18
Jan
6
PM
8
13
Chapters 3 and 4
Hays J et al. The Women’s Health Initiative
Recruitment Methods and Results
Ann Epidemiol 2003; 13: S18–S77.
Hypothesis testing and Chapters 5 and 6
sample size estimation
Sample size and Power In-class exercise
Laboratory
NOTE: THIS LABORATORY CLASS WILL BE
HELD IN THE ‘TRAINING ROOM’ OF THE
EINSTEIN LIBRARY: FORCHHEIMER BUILDING,
ROOM 119N
Cross-sectional and
cohort studies
Case-control studies
PF
Reading Assignment
Gary Taubes, “Do we really know what makes us
healthy?”, Sunday NY Times Mag, Sept 2007
Chapters 1 and 2
Clinical Trials I
Chapter 7
Stampfer MJ, et al. A prospective study of
postmenopausal estrogen therapy and coronary heart
disease. N Engl J Med 1985; 313:1044-49
Chapter 8
Jick H, Dinan B, Rothman KJ. Noncontraceptive
Estrogens and Nonfatal Myocardial Infarction JAMA
1978; 239(14):1407-1408
Chapters 10 and 11
15
20
PM
22
27
3
5
WHI Investigators. Risks and Benefits of Estrogen
Plus Progestin in Healthy Postmenopausal Women.
JAMA 2002;288:321-333.
Research using
existing data
Chapter 13
Southern WN, Bellin EY, Arnsten JH. Longer lengths
of stay and higher risk of mortality among inpatients of
physicians with more years in practice. Am J Med.
2011; 124: 868-74.
Chapter 9
Causal inference
PM
Evaluating diagnostic
tests
Research ethics
PF/PM
Review session
FINAL EXAM
29
Feb
Clinical Trials II
Chapter 12
Readings TBN
Chapter 14
Freeman, et al. Use of placebo surgery. NEJM 1999;
341: 988-92.
Macklin R. Ethical problems with sham surgery. NEJM
1999; 341: 992-6.
3
Einstein-Montefiore Institute for Clinical and Translational Research
“Design
and Conduct in Clinical Research”
Time:
Tuesdays and Thursdays (beginning December 2, 2015) 5:00-6:30 PM
Location:
Mazer 526
Albert Einstein College of Medicine Campus
Course Leaders:
Paul R. Marantz, MD, MPH; email: paul.marantz@einstein.yu.edu; Block/Mazer 517
Patricia Friedmann, MS; email: patricia.friedmann@einstein.yu.edu; Block/Mazer 613
Office hours: By appointment
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What year did you complete CR101?
Please submit completed form to nancy.marte@einstein.yu.edu and Merrilly.Calabrese@einstein.yu.edu