Randomized Trials

Learning Objectives

  1. Learn to apply the main features of designing a Randomized Trial .
    1. Formulate research hypotheses.
    2. Define eligibility criteria for study participants.
    3. Define exposure and outcomes .
  2. Learn the basic design features of a randomized trial.
    1. Describe the purpose of randomization .
    2. Describe the purpose of placebo control .
    3. Describe the purpose of blinding .
  3. Learn the main principles of analysis of a randomized trial.
    1. Describe the importance of " Intent-to-Treat " analysis.
    2. Calculate and interpret the incidence proportion (risk) , risk ratio (relative risk) , and risk difference .
  4. Learn the advantages and disadvantages of a randomized trial compared to other study designs.
    1. Describe some ethical considerations with respect to randomized trials.
    2. Describe the differences between observational and experimental studies.
    3. Describe the benefits and detriments of randomized trials with respect to internal validity , external validity (generalizability), cost-effectiveness and feasibility.