Post-Market Surveillance (PMS) in Oncology is vital for ensuring the safety and effectiveness of cancer therapies after market approval. Key objectives include safety monitoring (adverse events, RMPs), effectiveness evaluation (RWE, long-term outcomes), and regulatory compliance (PSURs).
Methods: PMS involves passive surveillance (spontaneous reporting), active surveillance (registries, EHRs), and sentinel systems (e.g., FDA’s Sentinel Initiative).
Challenges: Complex cancer treatments, data quality, and regulatory concerns complicate PMS efforts.
Future Directions: Advanced analytics, global collaboration, and patient engagement will enhance PMS through AI, international databases, and mHealth technologies.