Experimental Design

In-depth consideration of experimental study designs, with a focus on the various design options for randomized controlled trials (RCT) for medical and behavioral interventions. The strengths and limitations of the various experimental study design options as well as experimental approaches in comparison with related observational epidemiologic studies is discussed. Specific topics to be discussed include sampling, intervention allocation options, hypotheses that might be tested (e.g. superiority versus non-inferiority), sample size and power considerations, adverse event monitoring, regulatory (FDA) considerations, and statistical analysis of trial data. Students apply the concepts discussed to analyze data from an RCT and prepare their findings in manuscript format.

Spring

028713