An Overview of Statistical Considerations for Cardiovascular Biomarker Tests
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*Arkendra De, FDA/CDRH 

Keywords: measurement validation, clinical evaluation, cardiovascular

The aim of this presentation is to provide an overview of considerations that impact the statistical evaluation of cardiovascular biomarker tests. Considerations for measurement validation and clinical evaluation studies will be discussed. This presentation is based on De, A et al (2013) Journal of Cardiovascular Translational Research, Volume 6, Issue 4, pages 449-457.