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Clinical development success rates for investigational drugs

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The most comprehensive survey of clinical success rates across the drug industry to date shows productivity may be even lower than previous estimates.

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Figure 1: Phase success and LOA rates.
Figure 2: Phase success and LOA from phase 1 by disease for all indications.
Figure 3: NDA/BLA success rates.
Figure 4: Root-cause analysis for 359 phase 3 and 95 NDA/BLA suspended programs.

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Acknowledgements

This research was supported by Sagient Research Systems and the Biotechnology Industry Organization (BIO). The authors are indebted to the analysts at BioMedTracker who have collected these data. We would also like to thank our colleagues at BIO and BioMedTracker for their input and advice in the development of this study. The authors are solely responsible for the design, conduct and analysis of the study, and the conclusions that are drawn. The opinions expressed in this article are those of the authors and do not necessarily reflect the views of their employers.

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Correspondence to Michael Hay.

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M.H. and J.R. are employees of Sagient Research Systems, Inc. D.W.T. is an employee of Biotechnology Industry Organization. J.L.C. is the owner of Biotech Strategy & Analytics. C.E. is an employee of Prosensa Holding N.V.

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Hay, M., Thomas, D., Craighead, J. et al. Clinical development success rates for investigational drugs. Nat Biotechnol 32, 40–51 (2014). https://doi.org/10.1038/nbt.2786

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