Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval

被引：194

作者：

Eichler, H-G ^{[1
,2
]}

Oye, K. ^{[1
,3
,4
]}

Baird, L. G. ^{[1
]}

Abadie, E. ^{[5
]}

Brown, J. ^{[6
]}

Drum, C. L. ^{[1
]}

Ferguson, J. ^{[7
]}

Garner, S. ^{[8
,9
]}

Honig, P. ^{[10
]}

Hukkelhoven, M. ^{[11
]}

Limn, J. C. W. ^{[12
]}

Lim, R. ^{[13
]}

Lumpkin, M. M. ^{[14
]}

Neil, G. ^{[15
]}

O'Rourke, B. ^{[16
]}

Pezalla, E. ^{[17
]}

Shoda, D. ^{[18
]}

Seyfert-Margolis, V. ^{[14
]}

Sigal, E. V. ^{[19
]}

Sobotka, J. ^{[20
]}

Tan, D. ^{[12
]}

Unger, T. F. ^{[18
]}

Hirsch, G. ^{[1
]}

机构：

[1] MIT, Ctr Biomed Innovat, Cambridge, MA 02139 USA

[2] European Med Agcy, London, England

[3] MIT, Dept Polit Sci, Cambridge, MA 02139 USA

[4] MIT, Div Engn Syst, Cambridge, MA 02139 USA

[5] Agence Francais Securite Sanit Prod Sante, St Denis, France

[6] Harvard Univ, Sch Med, Dept Populat Med, Boston, MA USA

[7] Novartis Vaccines & Diagnost, Cambridge, MA USA

[8] Natl Inst Hlth & Clin Excellence, London, England

[9] Commonwealth Fund, New York, NY USA

[10] AstraZeneca, London, England

[11] Bristol Myers Squibb Co, New York, NY 10154 USA

[12] Singapore Hlth Sci Author, Singapore, Singapore

[13] Hlth Canada, Ottawa, ON K1A 0L2, Canada

[14] US FDA, Silver Spring, MD USA

[15] Johnson & Johnson, New Brunswick, NJ USA

[16] Canadian Agcy Drugs & Technol Hlth, Ottawa, ON, Canada

[17] Aetna, Hartford, CT USA

[18] Pfizer, New York, NY USA

[19] Friends Canc Res, Washington, DC USA

[20] Ohio No Univ, Raabe Coll Pharm, Ada, OH 45810 USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2012年 / 91卷 / 03期

关键词：

ACCESS; MEDICINES;

D O I：

10.1038/clpt.2011.345

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

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.

引用

页码：426 / 437

页数：12

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