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Trial watch

Phase II failures: 2008–2010

Nature Reviews Drug Discovery volume 10, pages 328–329 (2011)Cite this article

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Well-conducted Phase II clinical trials provide the data required to determine whether there is a case to be made, both scientifically and commercially, for progressing a drug candidate into Phase III trials. At present, however, Phase II success rates are lower than at any other phase of development. Analysis by the Centre for Medicines Research (CMR) of projects from a group of 16 companies (representing approximately 60% of global R&D spending) in the CMR International Global R&D database reveals that the Phase II success rates for new development projects have fallen from 28% (2006–2007) to 18% (2008–2009), although these success rates do vary between therapeutic areas and between small molecules and biologics. As the current likelihood of a drug successfully progressing through Phase III to launch is 50% (Nature Rev. Drug Discov. 10, 87; 2011), the overall attrition of late-stage drug development seems to be unsustainably high.

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Figure 1: Phase II failures: 2008–2010.

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  1. John Arrowsmith is a Scientific Director at Thomson Reuters, 77 Hatton Garden, London EC1N 8JS, UK. john.arrowsmith@thomsonreuters.com,

    John Arrowsmith

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Arrowsmith, J. Phase II failures: 2008–2010. Nat Rev Drug Discov 10, 328–329 (2011). https://doi.org/10.1038/nrd3439

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