All Times EDT
Keywords: biomarker, medical test, prognosis, therapy selection, monitoring, clinical utility
Biomarker-based tests play an important role in medicine for disease risk determination, detection, diagnostic confirmation, prognosis, therapy selection, treatment response assessment, and monitoring. Clinical use and complexity of biomarker-based tests has increased dramatically with more widespread implementation of precision medicine approaches. Translation of interesting research findings suggesting associations between biomarkers and various clinical conditions or endpoints to clinically useful tests requires a rigorous evidentiary process that includes establishment of analytical validity of the measurement system, clinical validity of the biomarker, and ultimately clinical utility of a biomarker test. This process requires engagement of a diverse research team including expertise in clinical and laboratory science, and biostatistics, as well as bioinformaticians and computational scientists when high complexity omics data are involved. Statistical and practical considerations along with illustrative examples focusing particularly on tests for prognosis, therapy selection, and monitoring, are discussed in the context of the recommended evidentiary framework.