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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.

With these issues in mind, here, we briefly discuss evidence related to the ability of clinical forecasting strategies to significantly reduce failure rates without impeding innovation, and highlight issues that need to be addressed to allow the widespread implementation of such strategies.

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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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