Understanding Serious Adverse Events in Clinical Trials

This chapter explores the impact of serious adverse events (SAEs) on long-term patient outcomes in clinical trials, particularly how hospitalizations can influence mortality rates. It discusses the evolution of statistical methodologies, including the introduction of win ratios and critiques traditional statistical measures like p-values and confidence intervals. The speakers emphasize the importance of accurate data interpretation and the challenges posed by biases inherent in using win ratios for trial event adjudication.