140.642.01 DESIGN OF CLINICAL EXPERIMENTS

Introduces the process for developing biomedical experiments from a statistical perspective. Stresses methods of controlling for bias and variability through outcome selection, design, sample size calculation, and analysis. Emphasizes clinical trials and other types of medical experiments likely to be encountered by biometric researchers. Discusses elements of analysis as related to the design principles.

Upon successful completion of this course, students will be able to: 1) understand basic clinical trial design principles including bias control, random error control, randomization, blocking, and masking; 2) have a working knowledge of quantitative properties of clinical trials including precision of estimation, power, sample size, and accrual dynamics; 3) have experience with specific types of designs of practical and historical interest including dose-finding, safety and efficacy, and comparative trials; 4) understand the importance of design and its relation to the analysis of clinical trials; 5) demonstrate knowledge of clinical trial methods by discussing specific design and/or analysis problems expertly.