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Safety in Early Phase Studies

In: Statistical Methods in Biomarker and Early Clinical Development

Author

Listed:
  • Laurence Colin

    (Novartis Institutes for Biomedical Research)

  • Brian Smith

    (Novartis Institutes for Biomedical Research)

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.

Suggested Citation

  • Laurence Colin & Brian Smith, 2019. "Safety in Early Phase Studies," Springer Books, in: Liang Fang & Cheng Su (ed.), Statistical Methods in Biomarker and Early Clinical Development, pages 247-274, Springer.
    • Handle: RePEc:spr:sprchp:978-3-030-31503-0_12
    DOI: 10.1007/978-3-030-31503-0_12
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