Safety in Early Phase Studies

Laurence Colin () and Brian Smith
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Laurence Colin: Novartis Institutes for Biomedical Research
Brian Smith: Novartis Institutes for Biomedical Research

A chapter in Statistical Methods in Biomarker and Early Clinical Development, 2019, pp 247-274 from Springer

Abstract: 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.

Date: 2019
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DOI: 10.1007/978-3-030-31503-0_12

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