Post-marketing studies Phase

This is a post-marketing study, to establish the long-term safety of a drug, especially when a biopharmaceutical is intended for prolonged use. If unexpected adverse effects are observed the product can be withdrawn from the market. Some Phase III licenses are granted with the condition that an additional study phase should follow according to a predefined plan. 

Post-marketing studies, also called phase IV studies, often have several objectives ... 

Phase IV Drug Development Post-Marketing Studies... 

CH10 PHASE IV DRUG DEVELOPMENT POST-MARKETING STUDIES... 

Phase IV. post-licensing studies in the target population, with widening of entry criteria to broaden experience in clinical practice study objectives are typically surveillance for safety or further comparisons with other therapies. The results of such trials are more likely to be used for marketing purposes than in support of applications to regulatory authorities. 

Phase 4, post-marketing surveillance studies. Often organised by drug manufacturers, they can provide valuable additional information from large numbers of patients. 

Sawada M, Nakamura S, Yamada A, Kobayashi T, Okada S. Phase IV study and post-marketing surveillance of ofloxacin in Japan. Chemotherapy 1991 37(2) 134-42. 

Market research activities, post-marketing surveillance studies, clinical assessments and the like must not be disguised promotion. The use to which the statistics or information is put may be promotional. The two phases must be kept distinct. 

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