Randomized Controlled Trials

3 units

This course provides a comprehensive introduction to randomized controlled clinical trials. Topics include types of clinical trials research (efficacy and effectiveness trials), study design, treatment allocation, randomization and stratification, quality control, analysis, sample size requirements, patient consent, data safety and monitoring plans, reporting standards, and interpretation of results. The role of randomized trials in comparative effectiveness research and the evaluation of prevention strategies is also addressed. Application of results of trials to inform practice is emphasized throughout. Evaluation: Students design a randomized controlled trial in their own field of interest, write a protocol for it, and critique recently published medical literature.