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European Medicines Agency Perspective on Oncology Study Design for Marketing Authorization and Beyond
Author(s) -
Jonsson B,
Martinalbo J,
Pignatti F
Publication year - 2017
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.612
Subject(s) - reimbursement , marketing authorization , authorization , agency (philosophy) , prior authorization , business , perspective (graphical) , marketing , regulatory agency , medicine , pharmacology , health care , political science , economics , public administration , computer science , bioinformatics , economic growth , philosophy , computer security , artificial intelligence , biology , epistemology
In the development of highly active anticancer drugs, the European situation may be viewed as paradoxical. Limited data may support marketing authorization, but may be insufficient for the health economic appraisal needed for reimbursement and market uptake. To achieve this, conventional confirmatory studies may be needed. For products of special interest, studies aimed at optimizing cost‐effectiveness may be warranted. Efficient designs of studies to meet these objectives constitute challenges to all stakeholders.