Clinical Development Success Rates, including likelihoods of approval (LoA)
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ABCDEFGHIJKLMNOPQRSTUVWXYZ
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YearStudySamplePhase I, LoA
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1991DiMasi et al. (1991).230
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2003DiMasi et al. (2003)First-in-humans, 1983-1994.215
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2003Gilbert et al (2003)2000-2002 (launch).080
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2006Adams and Brantner (2006)First-in-humans, 1989-2002, .24.240
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2007
DiMasi and Grabowski (2007)
First-in-humans, 1990-2003 (large molecule) .302
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2010Adams and Bratner (2010)Company R&D expenditures, 1985-2001.240
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2010Paul et. al. (2010)2007.117
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2012OHE (2012)In clinical development, 1997-1999,.107
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2014BIO (2014)Lead indications.153
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2014BIO (2014)All indications.102
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2016DiMasi et al. (2016)NME, 1990 to 2010.118
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2016BIO (2016)Oncology.051
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2016BIO (2016)Non Oncology.119
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2017Vinay and Malilankody (2017)NME, 9 of 10 Orphans.233
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2017Love (2017a)Orphan designations and approvals, 1990 to 2017.220
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2017Love (2017a)Orphan designations and approvals, 2010 to 2017.250
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Phase 1 LoA
DiMasi
BIO 2016
BIO 2014
Citations
 
 
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