학술논문

Shortcomings in the evaluation of biomarkers in ovarian cancer: a systematic review
Document Type
review-article
Source
Clinical Chemistry and Laboratory Medicine (CCLM). 58(1):3-10
Subject
biomarkers
biomarker development
clinical evaluations
ovarian cancer
study designs
Review
Language
English
ISSN
1437-4331
1434-6621
Abstract
Background Shortcomings in study design have been hinted at as one of the possible causes of failures in the translation of discovered biomarkers into the care of ovarian cancer patients, but systematic assessments of biomarker studies are scarce. We aimed to document study design features of recently reported evaluations of biomarkers in ovarian cancer. Methods We performed a systematic search in PubMed (MEDLINE) for reports of studies evaluating the clinical performance of putative biomarkers in ovarian cancer. We extracted data on study designs and characteristics. Results Our search resulted in 1026 studies; 329 (32%) were found eligible after screening, of which we evaluated the first 200. Of these, 93 (47%) were single center studies. Few studies reported eligibility criteria (17%), sampling methods (10%) or a sample size justification or power calculation (3%). Studies often used disjoint groups of patients, sometimes with extreme phenotypic contrasts; 46 studies included healthy controls (23%), but only five (3%) had exclusively included advanced stage cases. Conclusions Our findings confirm the presence of suboptimal features in clinical evaluations of ovarian cancer biomarkers. This may lead to premature claims about the clinical value of these markers or, alternatively, the risk of discarding potential biomarkers that are urgently needed.