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  • FROM THE ANALYST'S COUCH

The failure to fail smartly

  1. Steven Galson

    1. Global Regulatory Affairs and Safety, Amgen, Thousand Oaks, CA, USA.

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  2. Christopher P. Austin

    1. National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD, USA.

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  3. Eeshan Khandekar

    1. The National Academies of Sciences, Engineering, and Medicine, Washington, DC, USA.

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  4. Lynn D. Hudson

    1. Critical Path Institute, Tucson, AZ, USA.

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  5. Joseph A. DiMasi

    1. Tufts Center for the Study of Drug Development, Tufts University, Boston, MA, USA.

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  6. Robert Califf

    1. Verily Life Sciences, Mountain View, CA, USA.

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  7. John A. Wagner

    1. Cygnal Therapeutics, Cambridge, MA, USA.

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New drug development is highly risky and costly. There have been improvements in the most expensive and patient-intensive parts of the clinical development process in recent years, with phase III to approval success rates increasing from 49% to 62% from 2012 to 2017 (Nat. Rev. Drug Discov. 18, 495–496; 2019) and the Center for Medical Research (CMR) International analysis suggesting a downward trend in the number of projects terminated in phase III (Fig. 1). However, even with such improvements, more than one-third of new drugs fail between phase III and launch, which can force sponsors to abandon programmes after investing hundreds of millions of dollars.

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Nature Reviews Drug Discovery 20, 259-260 (2021)

doi: https://doi.org/10.1038/d41573-020-00167-0

Acknowledgements

The authors thank the staff of the National Academies Forum on Drug Discovery, Development, and Translation, including C. Shore and A. Wagner Gee, for contributing to the development of the action collaborative and review of this manuscript. Additional thanks go to D. Bearss and J. Mendoza-Torres from the Research Center at the National Academies for providing research support. The authors also thank M.D. Mostats from Amgen for his insight and technical assistance on benchmarking data. They gratefully acknowledge leadership made by the collaborative participants (listed in the supplementary information) and input by the many experts who shared their experience and suggestions on how to improve drug development. Lastly, the authors thank the members of the Forum on Drug, Discovery, Development and Translation for their guidance on developing the action collaborative.

Disclaimer

The Improving the Drug Development Process through Examining Late-Stage Failures Action Collaborative is an ad hoc activity associated with the US National Academies’ Forum on Drug Discovery, Development, and Translation. It does not necessarily represent the views of any one organization, the Forum, or the National Academies and is not subjected to the review procedures of, nor is it a report or product of, the National Academies.

Supplementary Information

  1. Supplementary Box 1

Competing Interests

S.G. is an employee of Amgen. R.C. is an employee of Verily Life Sciences. J.A.W. is an employee of Cygnal Therapeutics. C.P.A and J.A.W. are members of the FNIH Biomarkers Consortium executive committee. E.K., L.D.H. and J.A.D. declare no competing interests.

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