Biomarker Development, Methodological Challenges

Biomarker development is a common endeavor in medical research. The purpose to find indicators of disease occurrence or prognostic markers for response. process biomarkers often starts with showing mean differences between responders and non-responders those condition versus without. However, these statistically significant differences, while necessary are not sufficient validate biomarker. Sensitivity, specificity, positive negative predictive value at least as important the relative increase performance using biomarker over usual clinical variables should be demonstrated. This paper discusses various assessments context use biomarker, need characteristics addition importance independent validation putative biomarkers. Lastly, it hoped that thoroughness considered recognition task best difficult task.