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Health Technology Assessment in the Context of Adaptive Pathways for Medicines in Europe: Challenges and Opportunities
Author(s) -
Bouvy JC,
Jonsson P,
Longson C,
Crabb N,
Garner S
Publication year - 2016
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.448
Subject(s) - scope (computer science) , context (archaeology) , perspective (graphical) , agency (philosophy) , health technology , adaptive learning , adaptive design , political science , risk analysis (engineering) , medicine , process management , knowledge management , management science , business , computer science , engineering , health care , sociology , biology , artificial intelligence , clinical trial , social science , paleontology , pathology , law , programming language
Adaptive pathways for medicines have gained momentum and, in Europe, adaptive pathways have recently been introduced into the European Medicines Agency (EMA) processes after a successful 2‐year pilot. Although the concept, as initially proposed, contained several elements that would have required regulatory reforms, the adaptive pathways program has developed a more pragmatic scope (Box 1) . In this article, we explore the main challenges and opportunities adaptive pathways pose from a European health technology assessment (HTA) perspective .