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The Role of Statistics in Regulatory Decision Making

  • Special Issue on Statistics
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Abstract

The number of statistical challenges facing regulators remains high, as does the importance of statistical thinking in the regulatory decision-making process. Statisticians in the Office of Biostatistics at the US Food and Drug Administration review hundreds of new drug and therapeutic biologic applications each year and advise sponsors on protocols numbering in the thousands. In addition to remaining up to date on the newest statistical methods, statisticians are often called upon for innovative approaches to difficult regulatory problems. This article presents the author’s view of the important role that statisticians play in regulatory decision making, beginning with a broad overview of current office initiatives, including the development of guidance documents and a recent push for open and transparent collaboration with industry on methods development. Several recent examples are provided to illustrate the impact that statisticians can have on regulatory decisions through the use of strategic quantitative thinking. Also discussed are areas where it is believed that innovative statistical solutions or greater clarity on existing approaches is still needed.

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Authors and Affiliations

  1. Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Building 21, Room 3554, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA

    Lisa M. LaVange PhD

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  1. Lisa M. LaVange PhD
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Correspondence to Lisa M. LaVange PhD.

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Author Notes

Portions of this manuscript were presented at the DIA China Quantitative Science Forum, October 20–21, 2013, Beijing, China.

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LaVange, L.M. The Role of Statistics in Regulatory Decision Making. Ther Innov Regul Sci 48, 10–19 (2014). https://doi.org/10.1177/2168479013514418

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