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The risks of methodology aversion in drug regulation

Nature Reviews Drug Discovery volume 13, pages 317–318 (2014)Cite this article

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Decisions made by drug regulatory agencies require a high level of expertise in statistical methodologies. Without urgent efforts to enhance the level of such expertise in European regulatory agencies, there is a risk that they will not be able to meet emerging challenges such as quantitative modelling of benefit–risk profiles, wider use of innovative trial designs and greater public transparency of clinical trial data.

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Authors and Affiliations

  1. Center for Medical Statistics, Informatics, and Intelligent Systems, Section for Medical Statistics, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria

    Peter Bauer & Franz König

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  1. Peter Bauer
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  2. Franz König
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Correspondence to Peter Bauer or Franz König.

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The authors declare no competing financial interests.

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FURTHER INFORMATION

European Medicines Agency — Benefit–risk methodology project

European Medicines Agency — Concept paper on extrapolation of efficacy and safety in medicine development

European Medicines Agency — Publication and access to clinical-trial data

PROTECT Consortium — Review of methodologies for benefit and risk assessment of medication

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Bauer, P., König, F. The risks of methodology aversion in drug regulation. Nat Rev Drug Discov 13, 317–318 (2014). https://doi.org/10.1038/nrd4319

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