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Safety in Early Phase Studies

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Statistical Methods in Biomarker and Early Clinical Development

Abstract

Detecting safety signals in early phase studies is difficult, because many safety events are rare and sample size in early phase studies is generally small. To a large extent, the field of statistics has ignored the issue of safety in early development. In our view, there are several areas where statisticians can add value, by focusing on analyses which increase precision.

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Authors and Affiliations

  1. Novartis Institutes for Biomedical Research, Boston, MA, USA

    Laurence Colin & Brian Smith

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  1. Laurence Colin
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  2. Brian Smith
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Correspondence to Laurence Colin .

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Editors and Affiliations

  1. MyoKardia Inc., South San Francisco, CA, USA

    Liang Fang

  2. BioMarin Pharmaceutical Inc., San Rafael, CA, USA

    Cheng Su

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Colin, L., Smith, B. (2019). Safety in Early Phase Studies. In: Fang, L., Su, C. (eds) Statistical Methods in Biomarker and Early Clinical Development. Springer, Cham. https://doi.org/10.1007/978-3-030-31503-0_12

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