A more in-depth Introduction to clinical research with a focus on epidemiology and study design, including basic epidemiology, measures of association, basic statistics, cohort studies, case control studies, clinical trials, causal inference, and research ethics.
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, cross-sectional studies, cohort studies, case control studies, clinical trials, causal inference, and research ethics.
IMPORTANT NOTE: All classes will require advance preparation and active participation. In general, this will mean careful reading and reflection on the assigned textbook chapters before coming to class. Classroom discussions will be designed to elucidate concepts covered in the reading, and the faculty will presuppose that the students are all prepared. Students should anticipate and plan for approximately 1-3 hours of reading/reflection each week. Some classes will involve computer-based exercises, and will require students to bring their laptops to class.
Learning Objectives and Other Course Information
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 (prospective and retrospective cohort) study. Critique a case-control study and describe alternative observational designs.
- Explain the advantages and disadvantages of specific study designs for specific research questions. Design, interpret, and critique a randomized clinical trial.
- Distinguish internal and external validity in research.
- Explain the role of significance testing and interpret P values and confidence intervals. Interpret the major measures of association used in epidemiologic research.
- Describe the estimates and assumptions involved in sample size determination and perform simple power calculations.
- 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 “Pass/Fail”. We plan to use a criterion standard for grading: i.e., Pass >65%, Fail < 65%. As per graduate school regulations, a grade of “incomplete” may be allowed if absolutely necessary at the discretion of the Professors.
The grade will be determined using the following rubric:
- Assignments and informal presentations: 40%
- Research proposal (submitted via course website): 20%
- Attendance and class participation (preparation, contribution to discussion): 40%
Readings
There will be assigned readings to be completed before each class. These will include chapters from the textbook, Hulley et al (below), as well as original source materials (journal articles, etc.). Some assignments are listed on the Course Calendar page of this Syllabus, but other readings may be assigned throughout the course. The textbook must be purchased (or rented or downloaded) prior to the start of class; non-textbook readings will be available on the course page established on the Canvas learning management system.
Textbook
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 May be available for download, at no cost, through the Einstein library.
Research Proposal
Each student will submit a series of assignments towards the goal of developing a research proposal. The assignments will be due throughout the course, discussed in small groups (which consist of similar research topics), and informally presented to the class. At the end of the course, each small group will select one research proposal to present, and defend, to the class and a panel of experts.
Canvas
Canvas will be used as the main platform for posting course materials and communicating with students. All students must have their Canvas credentials established, and access confirmed, prior to the start of classes.
To register for this course, email Nancy.Marte@einsteinmed.edu
Course Leaders