Clinical Trials Methodology

We will examine the modern clinical trial as a methodology for evaluating interventions related to treatment, rehabilitation, prevention and diagnosis. Topics include the history and rationale for clinical trials, ethical issues, study design, protocol development, sample size considerations, quality assurance, statistical analysis, systematic reviews and meta-analysis, and reporting of results. Extensively illustrated with examples from various fields of health care research. Recommended prerequisites: introductory epidemiology and statistics. Pre-requisites: (PHP 2120 or PHP 2150) and either PHP 2508, 2510, or 2520. Open to graduate students only.