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Transition probabilities for clinical trials: investigating individual diseases

  1. Kathleen L. Miller

    1. Office of the Commissioner, US Food and Drug Administration, Maryland, USA.

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  2. Dina Rabinovitz

    1. Office of the Commissioner, US Food and Drug Administration, Maryland, USA.

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  3. Kirk W. Kerr

    1. Center for Drug Evaluation and Research, US Food and Drug Administration, Maryland, USA.

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Clinical trial transition probabilities, the probability that a drug product moves from one clinical phase to the next, are used to assess the efficiency of drug development and in the valuation of investigational drug projects. These rates are typically calculated at the level of therapeutic areas, but it is unclear whether the transition probabilities for therapeutic areas accurately predict the transition probabilities for individual diseases within those areas.

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Nature Reviews Drug Discovery 18, 658 (2019)

doi: https://doi.org/10.1038/d41573-019-00124-6

Disclaimer

The views expressed in this article are those of the authors and are not meant to represent the opinions of the US Food and Drug Administration (FDA). D.R. and K.W.K. completed this work while working for the FDA and have since moved to other organizations.

Supplementary Information

  1. Supplementary Box 1

Competing Interests

The authors declare no competing interests.

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