PhaseIVStudien
Phase IV studies, sometimes referred to as Phase IV Studien, are research investigations conducted after a drug, biologic, or vaccine has received market authorization. They focus on safety, long‑term risks, and real‑world effectiveness, providing information beyond preauthorization trials.
They employ a range of designs, including observational studies, registries, cohort and case‑control studies, spontaneous adverse
Regulatory and practical context: authorities may require or encourage Phase IV work as part of risk‑management
Objectives and value: Phase IV studies help detect rare or long‑term adverse events, evaluate effectiveness in
Challenges: observational methods are susceptible to confounding and bias; data quality and completeness vary; access to