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Challenges in planning and conducting diagnostic studies with molecular biomarkers.
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- Author(s): Ziegler A;Ziegler A; König IR; Schulz-Knappe P
- Source:
Deutsche medizinische Wochenschrift (1946) [Dtsch Med Wochenschr] 2013 May; Vol. 138 (19), pp. e2-24. Date of Electronic Publication: 2013 Apr 30.- Publication Type:
Journal Article; Review- Language:
English; German - Source:
- Additional Information
- Source: Publisher: G. Thieme Country of Publication: Germany NLM ID: 0006723 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1439-4413 (Electronic) Linking ISSN: 00120472 NLM ISO Abbreviation: Dtsch Med Wochenschr Subsets: MEDLINE
- Publication Information: Original Publication: Stuttgart [etc.] : G. Thieme, 1946-
- Subject Terms: Biomarkers/*analysis ; Molecular Diagnostic Techniques/*methods; Bias ; Evidence-Based Medicine/methods ; Evidence-Based Medicine/statistics & numerical data ; Humans ; Molecular Diagnostic Techniques/statistics & numerical data ; Patient Selection ; Predictive Value of Tests ; Prognosis ; Prospective Studies ; Reference Values ; Retrospective Studies
- Abstract: Biomarkers are of increasing importance for personalized medicine in many areas of application, such as diagnosis, prognosis, or the selection of targeted therapies. In many molecular biomarker studies, intensity values are obtained from large scale ‑omics experiments. These intensity values, such as protein concentrations, are often compared between at least two groups of subjects to determine the diagnostic ability of the molecular biomarker. Various prospective or retrospective study designs are available for molecular biomarker studies, and the biomarker used may be univariate or may even consist in a multimarker rule. In this work, several challenges are discussed for the planning and conduct of biomarker studies. The phases of diagnostic biomarker studies are closely related to levels of evidence in diagnosis, and they are therefore discussed upfront. Different study designs for molecular biomarker studies are discussed, and they primarily differ in the way subjects are selected. Using two systematic reviews from the literature, common sources of bias of molecular diagnostic studies are illustrated. The extreme selection of patients and controls and verification bias are specifically discussed. The pre-analytical and technical variability of biomarker measurements is usually expressed in terms of the coefficient of variation, and is of great importance for subsequent validation studies for molecular biomarkers. It is finally shown that the required sample size for biomarker validation quadratically increases with the coefficient of variation, and the effect is illustrated using real data from different laboratory technologies.
(© Georg Thieme Verlag KG Stuttgart · New York.) - Comments: Comment in: Dtsch Med Wochenschr. 2013 May;138(19):987-8. (PMID: 23633276)
- Accession Number: 0 (Biomarkers)
- Publication Date: Date Created: 20130502 Date Completed: 20130625 Latest Revision: 20171116
- Publication Date: 20221213
- Accession Number: 10.1055/s-0032-1327406
- Accession Number: 23633283
- Source:
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