140.633.11 BIOSTATISTICS IN MEDICAL PRODUCT REGULATION

Provides a broad understanding of the application of biostatistics in a regulatory context. Reviews the relevant regulations and guidance documents. Includes topics such as basic study design, target population, comparison groups, and endpoints. Addresses analysis issues with emphasis on the regulatory aspects, including issues of missing data and informative censoring. Discusses safety monitoring, interim analysis and early termination of trials with a focus on regulatory implications.

Upon successfully completing this course, students will be able to: 1) explain the relevance and application of statistics to the regulatory process; 2) differentiate between well-designed and conducted clinical research in the development and evaluation of new medical products; 3) locate internet sources for regulatory requirements, and regulatory review and evaluation information.