Focusing on the pharmaceutical non-statistician working within a very strict regulatory environment, Statistical Thinking for Clinical Trials in Drug Regulation provides the concepts and statistical thinking behind medical studies with a direct connection to the regulatory environment so that readers can be clear where the statistical methodology fits in with industry requirements. Pharmaceutical-related examples are used throughout to set the information in context. The book provides a detailed overview of the statistical aspects of the design, conduct, analysis, and presentation of data from clinical trials within drug regulation.