Design and Conduct of Clinical Research

Current Course Offerings:

Title: Design and Conduct of Clinical Research 
 

Time: Tuesdays and Thursdays (beginning December 6), 5:00-6:30 PM

Location: Forchheimer Educational Center

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 (prospective 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.  
  • 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 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 “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% 

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 well original source materials (journal articles, etc.). Some assignments are listed on the Course Calendar page of the Syllabus, but other readings may be assigned throughout the course. The textbook  must be purchased prior to December 1; non-textbook readings will be available on the course page established on the Canvas learning management system.

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

Final Exam 

There will be a take-home final exam, short answer/short essay format, to be submitted by February 16.

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 December 1.
 

Registration

For further information or to register, click here

Quicklinks

Design and Conduct of CR Syllabus 2016-17 (PDF) 

 For further information or to register, click here 

 
Click here to log in