This text provides an overview of the key issues in designing and analyzing observational biomarker studies. The failure to properly design and analyze such studies has led to falsely optimistic expectations regarding biomarker utility. The challenge in presenting relevant material is that the topics, although already published individually, are spread over a wide range of articles and textbooks in epidemiology, statistics and clinical research. This text pulls together all major concepts and presents the material in a non-mathematical fashion.
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