Towards validation of statistically reliable biomarkers

摘要

Biomarkers play an increasing role in the development of new cancer treatments. A biomarker can be formally defined as 'a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention' [1]. Biomarkers can include biochemical markers, cellular markers, cytokines, genetic markers, gene expression profiles, imaging markers, or physiological markers [2]. They can be measured once before a treatment is administered, or repeatedly before, during and after the treatment is administered, in which case interest focuses on changes in the biomarkers over time. In contrast to biomarkers, clinical endpoints directly measure 'how a patient feels, functions or survives' [3].