Clinical Development Success Rates for Investigational Drugs

Overview

Journal Nat Biotechnol

Specialty Biotechnology

Date 2014 Jan 11

PMID 24406927

Citations 811

Authors

Michael Hay

David W Thomas

John L Craighead

Celia Economides

Jesse Rosenthal

Affiliations

Soon will be listed here.

Citing Articles

Summarizing attributable factors and evaluating risk of bias of Mendelian randomization studies for Alzheimer's dementia and cognitive status: a systematic review and meta-analysis.

Meng X, Li X, Cao M, Dong J, Wang H, Cao W Syst Rev. 2025; 14(1):61.

PMID: 40082927 PMC: 11905674. DOI: 10.1186/s13643-025-02792-5.

Old drugs, new challenges: reassigning drugs for cancer therapies.

Czechowicz P, Wiech-Walow A, Slawski J, Collawn J, Bartoszewski R Cell Mol Biol Lett. 2025; 30(1):27.

PMID: 40038587 PMC: 11881393. DOI: 10.1186/s11658-025-00710-0.

Computational analysis of Ayurvedic herbs to explore their potential role as anti-cervical cancer agents.

Dange S, Aggarwal N, Verma R, Sinha Y, Dadhiya S, Mittal G Mol Biol Res Commun. 2025; 14(2):129-141.

PMID: 40028476 PMC: 11865937. DOI: 10.22099/mbrc.2024.51173.2038.

Empowering High Throughput Screening of 3D Models: Automated Dispensing of Cervical and Endometrial Cancer Cells.

Seymour S, Cadena I, Johnson M, Thakkar R, Jenne M, Adem I Cell Mol Bioeng. 2025; 18(1):71-82.

PMID: 39949489 PMC: 11813830. DOI: 10.1007/s12195-024-00841-y.

"Lost in translation?" Animal research in the era of precision medicine.

Fruhwein H, Paul N J Transl Med. 2025; 23(1):152.

PMID: 39905446 PMC: 11796152. DOI: 10.1186/s12967-025-06084-3.

References

DiMasi J, Feldman L, Seckler A, Wilson A . Trends in risks associated with new drug development: success rates for investigational drugs. Clin Pharmacol Ther. 2010; 87(3):272-7. DOI: 10.1038/clpt.2009.295. View

Sheck L, Cox C, Davis H, Trimble A, Wardell W, Hansen R . Success rates in the United States drug development system. Clin Pharmacol Ther. 1984; 36(5):574-83. DOI: 10.1038/clpt.1984.224. View

Kola I, Landis J . Can the pharmaceutical industry reduce attrition rates?. Nat Rev Drug Discov. 2004; 3(8):711-5. DOI: 10.1038/nrd1470. View

Henderson R, Cockburn I . Scale, scope, and spillovers: the determinants of research productivity in drug discovery. Rand J Econ. 1997; 27(1):32-59. View

Mullard A . 2012 FDA drug approvals. Nat Rev Drug Discov. 2013; 12(2):87-90. DOI: 10.1038/nrd3946. View

DiMasi J . Success rates for new drugs entering clinical testing in the United States. Clin Pharmacol Ther. 1995; 58(1):1-14. DOI: 10.1016/0009-9236(95)90066-7. View

Danzon P, Nicholson S, Pereira N . Productivity in pharmaceutical-biotechnology R&D: the role of experience and alliances. J Health Econ. 2005; 24(2):317-39. DOI: 10.1016/j.jhealeco.2004.09.006. View

DiMasi J, Hansen R, Grabowski H . The price of innovation: new estimates of drug development costs. J Health Econ. 2003; 22(2):151-85. DOI: 10.1016/S0167-6296(02)00126-1. View

DiMasi J . Risks in new drug development: approval success rates for investigational drugs. Clin Pharmacol Ther. 2001; 69(5):297-307. DOI: 10.1067/mcp.2001.115446. View

10.

Kaitin K, DiMasi J . Pharmaceutical innovation in the 21st century: new drug approvals in the first decade, 2000-2009. Clin Pharmacol Ther. 2010; 89(2):183-8. DOI: 10.1038/clpt.2010.286. View

11.

Cockburn I, Henderson R . Scale and scope in drug development: unpacking the advantages of size in pharmaceutical research. J Health Econ. 2002; 20(6):1033-57. DOI: 10.1016/s0167-6296(01)00108-4. View

12.

Cohen F . Macro trends in pharmaceutical innovation. Nat Rev Drug Discov. 2005; 4(1):78-84. DOI: 10.1038/nrd1610. View