PREP Course #19: Design of Randomized Clinical Trials

  • Recognize the need to understand fundamentals of study design when interpreting medical publications
  • Distinguish between observational and experimental study designs
  • Distinguish between cross-sectional, case-control, cohort designs and randomized clinical trials
  • Explain how a single research problem can be addressed by different designs
  • Identify sources of bias in proposed or published studies
  • Identify the essential tools that will assist them in the appropriate interpretation of study results
  • Describe characteristics of a well-designed randomized clinical trial


  • Class will be divided into 6 groups of 3 or more students each; there will be 3 paired groups: A1, A2; B1, B2; C1, C2.
  • Each pair will be assigned the same research problem requiring the design of a randomized clinical trial (RCT). The groups will confer (independently of one another) to propose an outline of a research design for their assigned problem. The designs will be presented to the class. The designs will be critiqued by the students and instructors. The concepts and terms (see list below) will be integrated into the critique session.
  • It is recognized that the students may not be well-versed in some of the clinical and medical aspects of a question. Accordingly, upon assigning a problem to a group, the instructors will provide some further background on the problem and will be available to answer questions during the design exercise.


Martin L Lesser, PhD, AVP, Biostatic Research

The Public Research Education Program (PREP) is a series of courses developed by various research support offices in conjunction with other health system offices. The courses offer CME credits and are designed to increase quality of research throughout the health system and streamline the process of conducting research.

PREP courses also aim to enhance and expand investigator capacity to conduct research. PREP courses are free and open to all Northwell Health employees, students, and volunteers. In addition, interested research collaborators and community partners are welcome to attend.

Light refreshments will be served at the courses held at the Goldman B Conference Room.

Don’t forget to check out select videos of PREP courses online.

For additional information, please visit:
Martin L Lesser, PhD, AVP, Biostatic Research
350 Community Drive
Manhasset, NY 11030