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Clinical forecasting in drug development

Nature Reviews Drug Discovery volume 6, pages 107–108 (2007)Cite this article

Obviously, clinical factors — drug efficacy and safety — have a major effect on attrition rates and the associated costs1,3. However, clinical forecasting to predict late-phase safety and efficacy based on earlier-phase clinical data with sufficient accuracy to facilitate early termination of eventual failures without stifling would-be successful drugs is a major challenge. Furthermore, although various market-forecasting approaches — which generally aim to assess the financial effect of future market share, competition and profitability — are established4, the working assumption of these approaches is that the drug in question will receive regulatory approval. Indeed, it has been noted that early-stage market-research efforts have almost always failed to predict blockbusters5, and so accurate clinical forecasts would also empower assumptions related to drug success that underlie market forecasts.

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Authors and Affiliations

  1. Division of Health Sciences and Technology, co-founders of Phorecaster and faculty members of the Children's Hospital Informatics Program at Harvard–MIT, 320 Longwood Avenue, Boston, 02115-5737, Massachusetts, USA

    Asher D. Schachter

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  1. Asher D. Schachter
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  2. Marco F. Ramoni
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Correspondence to Asher D. Schachter.

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Competing interests

The authors are co-founders of the company Phorecaster, which provides consulting services to model outcomes in drug development.

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Schachter, A., Ramoni, M. Clinical forecasting in drug development. Nat Rev Drug Discov 6, 107–108 (2007). https://doi.org/10.1038/nrd2246

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