Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval
| Autor: | Lynn G. Baird, E. V. Sigal, Jeffrey S. Brown, D. Tan, Robyn Lim, H. G. Eichler, Kenneth A. Oye, Vicki L. Seyfert-Margolis, E Pezalla, J Ferguson, Brian O'Rourke, Sarah Garner, J. Sobotka, John C W Lim, Chester L. Drum, Thomas F. Unger, P. Honig, Diane Shoda, Mathias Hukkelhoven, G. Neil, E. Abadie, M. M. Lumpkin, Gigi Hirsch |
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| Rok vydání: | 2012 |
| Předmět: |
Pharmacology
Health Services Needs and Demand Data collection business.industry Management science Emerging technologies Decision Making Legislature United States Transformative learning Action (philosophy) Experimental therapy Drug approval Animals Humans Medicine media_common.cataloged_instance Pharmacology (medical) European Union European union business Drug Approval Licensure media_common |
| Zdroj: | Clinical Pharmacology & Therapeutics. 91:426-437 |
| ISSN: | 1532-6535 0009-9236 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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