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Clinical development success rates for investigational drugs.

作者信息

Hay Michael, Thomas David W, Craighead John L, Economides Celia, Rosenthal Jesse

机构信息

BioMedTracker, Sagient Research Systems, San Diego, California, USA.

Biotechnology Industry Organization (BIO), Washington, DC, USA.

出版信息

Nat Biotechnol. 2014 Jan;32(1):40-51. doi: 10.1038/nbt.2786.

DOI:10.1038/nbt.2786

PMID:24406927

Abstract

摘要

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Pharmaceutical innovation in the 21st century: new drug approvals in the first decade, 2000-2009.

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Clin Pharmacol Ther. 2010 Mar;87(3):272-7. doi: 10.1038/clpt.2009.295. Epub 2010 Feb 3.

Productivity in pharmaceutical-biotechnology R&D: the role of experience and alliances.

J Health Econ. 2005 Mar;24(2):317-39. doi: 10.1016/j.jhealeco.2004.09.006. Epub 2005 Jan 25.

Macro trends in pharmaceutical innovation.

Nat Rev Drug Discov. 2005 Jan;4(1):78-84. doi: 10.1038/nrd1610.

Can the pharmaceutical industry reduce attrition rates?

Nat Rev Drug Discov. 2004 Aug;3(8):711-5. doi: 10.1038/nrd1470.

The price of innovation: new estimates of drug development costs.

J Health Econ. 2003 Mar;22(2):151-85. doi: 10.1016/S0167-6296(02)00126-1.

Scale and scope in drug development: unpacking the advantages of size in pharmaceutical research.

J Health Econ. 2001 Nov;20(6):1033-57. doi: 10.1016/s0167-6296(01)00108-4.

Risks in new drug development: approval success rates for investigational drugs.

Clin Pharmacol Ther. 2001 May;69(5):297-307. doi: 10.1067/mcp.2001.115446.

Scale, scope, and spillovers: the determinants of research productivity in drug discovery.

Rand J Econ. 1996 Spring;27(1):32-59.

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相似文献

Clinical development success rates for investigational drugs.

Nat Biotechnol. 2014 Jan;32(1):40-51. doi: 10.1038/nbt.2786.

The Federal Right to Try Act of 2017-A Wrong Turn for Access to Investigational Drugs and the Path Forward.

JAMA Intern Med. 2018 Mar 1;178(3):321-322. doi: 10.1001/jamainternmed.2017.8167.

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Nat Rev Drug Discov. 2015 Jul;14(7):450-1. doi: 10.1038/nrd4651. Epub 2015 May 22.

Regulatory watch: FDA guidance on co-developing investigational drugs.

Nat Rev Drug Discov. 2011 Feb;10(2):86. doi: 10.1038/nrd3363.

Experimental drugs on trial.

Sci Am. 2007 Oct;297(4):92-9. doi: 10.1038/scientificamerican1007-92.

New FDA breakthrough-drug category--implications for patients.

N Engl J Med. 2014 Mar 27;370(13):1252-8. doi: 10.1056/NEJMhle1311493.

Looking for a miracle.

New Sci. 2000 Jun 24;166(2244):16-7.

Right to try?

J Clin Oncol. 2015 May 1;33(13):1518. doi: 10.1200/JCO.2014.60.6004. Epub 2015 Mar 16.

Breakthrough-Therapy Designation - An FDA Perspective.

N Engl J Med. 2018 Apr 12;378(15):1457-1458. doi: 10.1056/NEJMc1801222.

Notification vs approval.

Ocul Surf. 2007 Jul;5(3):255-8. doi: 10.1016/s1542-0124(12)70616-x.

引用本文的文献

2‑Aminoimidazole-benzimidazole Conjugates Potentiate the Gram-Positive Selective Antibiotic Clarithromycin against .

ACS Med Chem Lett. 2025 Jul 1;16(8):1562-1568. doi: 10.1021/acsmedchemlett.5c00201. eCollection 2025 Aug 14.

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Cureus. 2025 Jun 4;17(6):e85380. doi: 10.7759/cureus.85380. eCollection 2025 Jun.

本文引用的文献

2012 FDA drug approvals.

Nat Rev Drug Discov. 2013 Feb;12(2):87-90. doi: 10.1038/nrd3946.

Pharmaceutical innovation in the 21st century: new drug approvals in the first decade, 2000-2009.

Clin Pharmacol Ther. 2011 Feb;89(2):183-8. doi: 10.1038/clpt.2010.286. Epub 2010 Dec 29.

Trends in risks associated with new drug development: success rates for investigational drugs.

Clin Pharmacol Ther. 2010 Mar;87(3):272-7. doi: 10.1038/clpt.2009.295. Epub 2010 Feb 3.

Productivity in pharmaceutical-biotechnology R&D: the role of experience and alliances.

J Health Econ. 2005 Mar;24(2):317-39. doi: 10.1016/j.jhealeco.2004.09.006. Epub 2005 Jan 25.

Macro trends in pharmaceutical innovation.

Nat Rev Drug Discov. 2005 Jan;4(1):78-84. doi: 10.1038/nrd1610.

Can the pharmaceutical industry reduce attrition rates?

Nat Rev Drug Discov. 2004 Aug;3(8):711-5. doi: 10.1038/nrd1470.

The price of innovation: new estimates of drug development costs.

J Health Econ. 2003 Mar;22(2):151-85. doi: 10.1016/S0167-6296(02)00126-1.

Scale and scope in drug development: unpacking the advantages of size in pharmaceutical research.

J Health Econ. 2001 Nov;20(6):1033-57. doi: 10.1016/s0167-6296(01)00108-4.

Risks in new drug development: approval success rates for investigational drugs.

Clin Pharmacol Ther. 2001 May;69(5):297-307. doi: 10.1067/mcp.2001.115446.

Scale, scope, and spillovers: the determinants of research productivity in drug discovery.

Rand J Econ. 1996 Spring;27(1):32-59.