Inadequate Reporting of Analytical Characteristics of Biomarkers Used in Clinical Research: A Threat to Interpretation and Replication of Study Findings

• Published in: Clinical chemistry (Baltimore, Md.) Md.), 2019-12, Vol.65 (12), p.1554-1562
• Main Authors: Sun, Qian, Welsh, Kerry J, Bruns, David E, Sacks, David B, Zhao, Zhen
• Format: Article
• Language: English
• Subjects: Accuracy; Archives & records; Biomarkers; Biomarkers - analysis; Clinical trials; Data Analysis; FDA approval; Humans; Internal medicine; Mathematical analysis; Measurement methods; Medicine; Methods; Patients; Publishing - trends; Reproducibility of Results; Studies
• ISSN: 0009-9147; 1530-8561
• DOI: 10.1373/clinchem.2019.309575

Analytical characteristics of methods to measure biomarkers determine how well the methods measure what they claim to measure. Transparent reporting of analytical characteristics allows readers to assess the validity and generalizability of clinical studies in which biomarkers are used. Our aims were to assess the reporting of analytical characteristics of biomarkers used in clinical research and to evaluate the extent of reported characterization procedures for assay precision. We searched 5 medical journals ( , , , , and ) over a 10-year period for the term "biomarker" in the full-text field. We included studies in which biomarkers were used for inclusion/exclusion of study participants, for patient classification, or as a study outcome. We tabulated the frequencies of reporting of 11 key analytical characteristics (such as analytical accuracy of test results) in the included studies. A total of 544 studies and 1299 biomarker uses met the inclusion criteria. No information on analytical characteristics was reported for 67% of the biomarkers. For 65 biomarkers (3%), ≥4 characteristics were reported (range, 4-8). The manufacturer of the measurement procedure could not be determined for 688 (53%) of the 1299 biomarkers. The extent of assessments of assay imprecision, when reported, did not meet expectations for clinical use of biomarkers. Reporting of the analytical performance of biomarker measurements is variable and often absent from published clinical studies. We suggest that readers need fuller reporting of analytical characteristics to interpret study results, assess generalizability of conclusions, and compare results among clinical studies.