Clinical Trials and Intervention Studies

3 Units

Issues in the design, organization, and operation of randomized, controlled clinical trials and intervention studies. Emphasis on long-term multicenter trials. Topics include legal and ethical issues in the design; application of concepts of controls, masking, and randomization; steps required for quality data collection; monitoring for evidence of adverse or beneficial treatment effects; elements of organizational structure; sample size calculations and data analysis procedures; and common mistakes. Recommended preparation: PQHS 431 . Offered as PQHS 450 and MPHP 450 .