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 healthcare professionals and patients themselves play a crucial role in reporting adverse events directly to national agencies like the FDA and EMA. The concept of active surveillance, using large electronic healthcare databases to proactively search for potential safety signals, is explored. We also discuss the importance of exclusion criteria in clinical trials to minimize risks by carefully selecting participants. Tune in for a comprehensive understanding of the multi-layered systems that work together to protect patient safety throughout the entire drug development process.