Clinical development success rates for investigational drugs

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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  1. 1.

    , ed. Citeline Drug Intelligence. Pharma R&D Annual Review 2011. (Citeline Drug Intelligence, 2012).

  2. 2.

    EvaluatePharma. World Preview 2018: Embracing the Patent Cliff. (2012).

  3. 3.

    Pharmaceutical Research and Manufacturers of America. Annual Report 2011. (2011).

  4. 4.

    2012 FDA drug approvals. Nat. Rev. Drug Discov. 12, 87–90 (2013).

  5. 5.

    Macro trends in pharmaceutical innovation. Nat. Rev. Drug Discov. 4, 78–84 (2005).

  6. 6.

    , , & Trends in risks associated with new drug development: success rates for investigational drugs. Clin. Pharmacol. Ther. 87, 272–277 (2010).

  7. 7.

    & Pharmaceutical innovation in the 21st century: new drug approvals in the first decade, 2000–2009. Clin. Pharmacol. Ther. 89, 183–188 (2011).

  8. 8.

    & Can the pharmaceutical industry reduce attrition rates? Nat. Rev. Drug Discov. 3, 711–715 (2004).

  9. 9.

    , & Pharmaceutical Development Phases: A Duration Analysis. Working paper no. 274. (US Federal Trade Commission: Bureau of Economics, 2004).

  10. 10.

    & Scale, scope, and spillovers: the determinants of research productivity in drug discovery. Rand J. Econ. 27, 32–59 (1996).

  11. 11.

    & Scale and scope in drug development: unpacking the advantages of size in pharmaceutical research. J. Health Econ. 20, 1033–1057 (2001).

  12. 12.

    , & Productivity in pharmaceutical–biotechnology R&D: the role of experience and alliances. J. Health Econ. 24, 317–339 (2005).

  13. 13.

    , , & A breath of fresh air? Firm type, scale, scope, and selection effects in drug development. Manage. Sci. 55, 1638–1653 (2009).

  14. 14.

    et al. Success rates in the United States drug development system. Clin. Pharmacol. Ther. 36, 574–583 (1984).

  15. 15.

    , & The Outcome of Research on New Molecular Entities Commencing Clinical Research in the Years 1976–79 (OPE Study 77). (Office of Planning and Evaluation, US Food and Drug Administration, Rockville, MD, 1988).

  16. 16.

    Success rates for new drugs entering clinical testing in the United States. Clin. Pharmacol. Ther. 58, 1–14 (1995).

  17. 17.

    Risks in new drug development: approval success rates for investigational drugs. Clin. Pharmacol. Ther. 69, 297–307 (2001).

  18. 18.

    , & The price of innovation: new estimates of drug development costs. J. Health Econ. 22, 151–185 (2003).

  19. 19.

    & The cost of biopharmaceutical R&D: is biotech different? Manag. Decis. Econ. 28, 469–479 (2007).

  20. 20.

    in 2010 American Society of Clinical Oncology (ASCO) Annual Meeting (Chicago, IL; 2010).

  21. 21.

    FDA. Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics. (FDA, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, 2010).

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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.

Author information


  1. Michael Hay and Jesse Rosenthal are at BioMedTracker, Sagient Research Systems, San Diego, California, USA

    • Michael Hay
    •  & Jesse Rosenthal
  2. David W. Thomas and Celia Economides are at the Biotechnology Industry Organization (BIO), Washington, DC, USA

    • David W Thomas
    •  & Celia Economides
  3. John L. Craighead is at Biotech Strategy & Analytics, Rockville, Maryland, USA.

    • John L Craighead


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Competing interests

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.

Corresponding author

Correspondence to Michael Hay.

Supplementary information

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    Supplementary Figures and Supplementary Tables

    Supplementary Figures 1 and 2 and Supplementary Tables 1 and 2