This episode focuses on the critical systems for monitoring, reporting, and managing adverse events in large, multicenter clinical trials. We define adverse events and discuss the challenges of accurately identifying and assessing them, especially in complex conditions like cancer. The importance of standardized reporting using tools like the NCI Common Toxicity Criteria (CTC) is highlighted. We explore the roles and responsibilities of various stakeholders, including research sponsors, investigators, and regulatory agencies like the FDA, in ensuring patient safety during trials. Join us as we unpack the complexities of managing risk in these large-scale studies.

This episode further examines the ongoing safety surveillance that occurs after a drug is approved and enters the market, often referred to as the post-market phase. We discuss how ...