Track 43: Post-Marketing Surveillance Studies

Overview: Post-Marketing Surveillance Studies

Post-Marketing Surveillance (PMS) studies—also known as Phase IV clinical trials—are conducted after a drug or medical device has been approved and launched into the market. These studies aim to monitor long-term safety, effectiveness, and real-world usage, which may not be fully captured during pre-approval trials due to limited sample size or duration. PMS plays a crucial role in identifying rare or delayed adverse effects, evaluating drug interactions, and studying medication use in broader patient populations, including those with comorbidities or from diverse demographics. Insights gained from PMS studies can lead to label updates, usage restrictions, or even product withdrawals if necessary.

Key Sub-Topics in Post-Marketing Surveillance Studies:

Phase IV Clinical Trials · Real-World Evidence (RWE) · Spontaneous Adverse Event Reporting · Risk Evaluation and Mitigation Strategies (REMS) · Long-Term Safety Monitoring · Drug Utilization Studies · Pharmacovigilance Systems · Patient Registries · Post-Authorization Safety Studies (PASS) · Label Expansion Studies · Effectiveness in Diverse Populations · Comparative Effectiveness Research · Off-Label Use Monitoring · Health Technology Assessment (HTA) · Regulatory Compliance and Reporting