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Two decades of new drug development for central nervous system disorders

Nature Reviews Drug Discovery volume 14, pages 815–816 (2015)Cite this article

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Analysis

We identified all compounds related to CNS conditions that entered Phase I trials between 1990 and 2012 from Pharmaprojects (see Supplementary information S1 (box) for details of data and analysis). Using methods we previously described (Science 344, 967–969; 2014), we extracted the major indication, start and end dates of each phase of clinical testing, date of regulatory approval (if applicable), and date and reason for discontinuation (for example, failure to demonstrate efficacy, safety concerns or commercial reasons). We tabulated all new Phase I, II and III trials for CNS drugs, as well as the proportion of new CNS and cancer drugs relative to all new clinical trials. We quantified the differential rates of survival of CNS drugs, defined as the probability of successfully proceeding from one clinical trial phase to the subsequent one, or to regulatory filing. Finally, we searched publicly available sources for mention of the discontinued compound and, if available, the stated reasons for discontinuation.

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Figure 1: Trends in drugs entering clinical trials for central nervous system disorders compared with other therapeutic areas: 1990–2012.
Figure 2: Drugs in clinical trials for central nervous system disorders: 1990–2012.

Acknowledgements

The authors would like to thank J. Karlawish, B. Hyman, M. Albers and A. Sarpatwari for their comments on an earlier draft.

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Authors and Affiliations

  1. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, 02120, Massachusetts, USA

    Aaron S. Kesselheim & Jessica M. Franklin

  2. Harvard University, Cambridge, Massachusetts, and Bain Capital, Boston, 02116, Massachusetts, USA

    Thomas J. Hwang

Authors
  1. Aaron S. Kesselheim
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  2. Thomas J. Hwang
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Corresponding author

Correspondence to Aaron S. Kesselheim.

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Competing interests

Since submission of this manuscript, T.J.H. has been employed by Bain Capital, which has invested in health care companies but had no involvement in the study. The authors' funders, grantors and employers had no role in the design and conduct of the study; collection, management, analysis and intepretation of the data; preparation, review and approval of the manuscript; and decision to submit the manuscript for publication.

Supplementary information

Supplementary information S1 (box)

Data, analysis methods and additional results (PDF 277 kb)

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Kesselheim, A., Hwang, T. & Franklin, J. Two decades of new drug development for central nervous system disorders. Nat Rev Drug Discov 14, 815–816 (2015). https://doi.org/10.1038/nrd4793

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