The Handbook of Neuropsychiatric Biomarkers, Endophenotypes and Genes 2009
DOI: 10.1007/978-1-4020-9464-4_2
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Methodological and Statistical Issues in the Use of Biomarkers in Clinical and Research Studies

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“…Finally, when a biomarker displays adequate sensitivity, specificity and predictive value in the validation phase, its effect on diagnostic or prognostic outcomes or its cost-effectiveness can be determined in the context of a randomized controlled trial (RCT) (Step 5). The lack of RCTs in psychiatric research, therefore, reflects the newness of the development of biomarkers in mental illness (Van Lieshout and Szatmari, 2009). It is important to keep in mind, however, that while the methodological rigor increases from cross-sectional and case–control studies to longitudinal cohorts with RCTs, in some circumstances cross-sectional studies can provide highly valuable information about the accuracy of a test (Schunemann et al, 2008).…”
Section: Introductionmentioning
confidence: 99%
“…Finally, when a biomarker displays adequate sensitivity, specificity and predictive value in the validation phase, its effect on diagnostic or prognostic outcomes or its cost-effectiveness can be determined in the context of a randomized controlled trial (RCT) (Step 5). The lack of RCTs in psychiatric research, therefore, reflects the newness of the development of biomarkers in mental illness (Van Lieshout and Szatmari, 2009). It is important to keep in mind, however, that while the methodological rigor increases from cross-sectional and case–control studies to longitudinal cohorts with RCTs, in some circumstances cross-sectional studies can provide highly valuable information about the accuracy of a test (Schunemann et al, 2008).…”
Section: Introductionmentioning
confidence: 99%