ED04 - Biomarker Studies: Study Design and Statistical Considerations

DESCRIPTION

Simulcast viewing available in AACR Session Central, Hall B.

Biomarkers are playing an increasing important role in early diagnosis, prognosis, treatment selection, and population risk assessment. However, initial biomarker discovery studies often fail to validate in larger retrospective or prospective studies or demonstrate clinical utility. There is a significant knowledge gap in statistical evaluation from discovery to validation and clinical translation in biomarker development. This educational session will provide an overview of the design and statistical considerations of biomarker studies from discovery, validation, and clinical utility for early detection, precision medicine, and population risk assessment. The attendees will be introduced to the different phases of biomarker studies, objectives and endpoints, common study designs and statistical methods in settings of early detection, prognosis, treatment, and cancer risk assessment.