期刊
CLINICAL PHARMACOLOGY & THERAPEUTICS
卷 91, 期 3, 页码 426-437出版社
WILEY
DOI: 10.1038/clpt.2011.345
关键词
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资金
- Sloan Foundation
- Kauffman Foundation
- Merck Company Foundation
- Massachusetts Technology Collaborative
- Sanofi
- Alnylam
- Amgen
- Biogen-Idec
- Biomarin
- Bristol-Myers Squibb
- Genentech
- GlaxoSmithKline
- Inno Biologics
- Johnson Johnson
- LFB Biotechnologies
- Merrimack Pharmaceuticals
- Metabolix
- Millipore
- Novartis
- Pfizer
- Quintiles
- Sanofi Pasteur
- Burroughs Wellcome Foundation
Traditional drug licensing approaches are based on binary decisions. At the moment of licensing, an experimental therapy is presumptively transformed into a fully vetted, safe, efficacious therapy. By contrast, adaptive licensing (AL) approaches are based on stepwise learning under conditions of acknowledged uncertainty, with iterative phases of data gathering and regulatory evaluation. This approach allows approval to align more closely with patient needs for timely access to new technologies and for data to inform medical decisions. The concept of AL embraces a range of perspectives. Some see AL as an evolutionary step, extending elements that are now in place. Others envision a transformative framework that may require legislative action before implementation. This article summarizes recent AL proposals; discusses how proposals might be translated into practice, with illustrations in different therapeutic areas; and identifies unresolved issues to inform decisions on the design and implementation of AL.
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