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Qualification Versus Validation Of Biomarkers, Jenny Doust

Jenny Doust

The phases of research used to evaluate new drugs provide a useful reference point for determining the studies that need to be conducted to evaluate new biomarkers. However, biomarkers do not have a single pathway for changing health outcomes and may be used for a variety of purposes, such as improving diagnostic criteria, improving prognosis, improving the monitoring of disease or as a measurement of health outcomes. The impact on health outcomes is also less direct and is dependent on the sequence of actions taken as a consequence of the test results. The different purposes of biomarkers and the less …