This course is designed to provide students with an understanding of the main concepts and issues in clinical trial design and interpretation. The course will concentrate on the design, conduct, analysis, interpretation, and dissemination of results in clinical trials research. Topics include bias control, random error control, randomization, blocking, masking, precision of estimation, power, sample size, accrual dynamics, types of trial designs, analysis of trial results and federal regulations. The overarching goal of the course is to familiarize students with the clinical trials process.
Upon completion of this course students will:
1. Understand clinical trials design including randomization, control of bias, blocking, and masking.
2. Be able to identify and speak competently on the most common study designs including: treatment trials, safety and efficacy trials, and comparative effectiveness trials.
3. Understand basic statistical concepts imperative to the conduct of clinical trials including: precision estimation, multiple comparisons, and power analysis.
4. Understand the relationship between study design and study analysis.