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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.

References

  1. Lloyd, I., ed. Citeline Drug Intelligence. Pharma R&D Annual Review 2011. http://www.citeline.com/wp-content/uploads/Citleine-Pharma-RD-annual-review-20111.pdf (Citeline Drug Intelligence, 2012).

    Google Scholar 

  2. EvaluatePharma. World Preview 2018: Embracing the Patent Cliff. http://info.evaluatepharma.com/WP2018_ELS_LP.html (2012).

  3. Pharmaceutical Research and Manufacturers of America. Annual Report 2011. http://www.phrma.org/sites/default/files/159/phrma_2011_annual_report.pdf (2011).

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

    Article  Google Scholar 

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

    Article  CAS  Google Scholar 

  6. DiMasi, J.A., Feldman, L., Seckler, A. & Wilson, A. Trends in risks associated with new drug development: success rates for investigational drugs. Clin. Pharmacol. Ther. 87, 272–277 (2010).

    Article  CAS  Google Scholar 

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

    Article  CAS  Google Scholar 

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

    Article  CAS  Google Scholar 

  9. Abrantes-Metz, R., Adams, C. & Metz, A. Pharmaceutical Development Phases: A Duration Analysis. Working paper no. 274. http://www.ftc.gov/be/workpapers/wp274.pdf (US Federal Trade Commission: Bureau of Economics, 2004).

    Google Scholar 

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

    Article  CAS  Google Scholar 

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

    Article  CAS  Google Scholar 

  12. Danzon, P.M., Nicholson, S. & Pereira, N.S. Productivity in pharmaceutical–biotechnology R&D: the role of experience and alliances. J. Health Econ. 24, 317–339 (2005).

    Article  Google Scholar 

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

    Article  Google Scholar 

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

    Article  CAS  Google Scholar 

  15. Tucker, S.A., Blozan, C. & Coppinger, P. 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. DiMasi, J.A. Success rates for new drugs entering clinical testing in the United States. Clin. Pharmacol. Ther. 58, 1–14 (1995).

    Article  CAS  Google Scholar 

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

    Article  CAS  Google Scholar 

  18. DiMasi, J.A., Hansen, R.W. & Grabowski, H.G. The price of innovation: new estimates of drug development costs. J. Health Econ. 22, 151–185 (2003).

    Article  Google Scholar 

  19. DiMasi, J.A. & Grabowski, H.G. The cost of biopharmaceutical R&D: is biotech different? Manag. Decis. Econ. 28, 469–479 (2007).

    Article  Google Scholar 

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

    Google Scholar 

  21. FDA. Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm201790.pdf (FDA, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, 2010).

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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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Authors and Affiliations

  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

Authors
  1. Michael Hay
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  2. David W Thomas
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  3. John L Craighead
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  4. Celia Economides
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  5. Jesse Rosenthal
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Corresponding author

Correspondence to Michael Hay.

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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.

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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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