Key Statistical Concepts in Clinical Trials for Pharma

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Focusing on the inferential analysis of data from pharmaceutical clinical trials, the book explores crucial statistical concepts essential for evaluating drug safety and efficacy. It addresses how these analyses inform decision-making at both the public health level, particularly by regulatory agencies, and the individual patient level, involving physicians and patients. Key topics include statistical significance, clinical significance, and the balance of benefits and risks associated with new drug approvals and prescriptions.