Course: Biostatistics for Medical Product Regulation
Biostatistics for Medical Product Regulation
Mary Foulkes and Simon Day
Originally Offered :
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.