Methodological and Statistical Issues in the Use of Biomarkers in Clinical and Research Studies

The study of biomarkers has great promise for advancing knowledge in clinical practice and research in mental health. Biomarkers have the potential to improve our ability to diagnose individuals with a psy chiatric disorder, to screen populations at risk of devel oping disorders, to provide prognostic information to those who manifest prodromal signs or to those who already have a disorder, and to help individuals make decisions about the most appropriate treatments (treat ment response). However, there are many methodologi cal and statistical issues that must be kept in mind as biomarkers are validated in research studies and before they can be considered useful for clinical practice.