Publication of Tumor Marker Research Results: The Necessity for Complete and Transparent Reporting

被引:139
作者
McShane, Lisa M. [1 ,2 ]
Hayes, Daniel F. [3 ]
机构
[1] NCI, Biometr Res Branch, Bethesda, MD 20892 USA
[2] NCI, Canc Diag Program, Bethesda, MD 20892 USA
[3] Univ Michigan, Breast Oncol Program, Ctr Comprehens Canc, Ann Arbor, MI 48109 USA
关键词
CELL LUNG-CANCER; CONSORT STATEMENT; AMERICAN SOCIETY; CLINICAL-TRIALS; BREAST-CANCER; REVISED RECOMMENDATIONS; ADJUVANT CHEMOTHERAPY; PROGNOSTIC-FACTORS; RANDOMIZED TRIALS; QUALITY;
D O I
10.1200/JCO.2012.42.6858
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Clinical management decisions for patients with cancer are increasingly being guided by prognostic and predictive markers. Use of these markers should be based on a sufficiently comprehensive body of unbiased evidence to establish that benefits to patients outweigh harms and to justify expenditure of health care dollars. Careful assessments of the clinical utility of markers by using comparative effectiveness research methods are urgently needed to more rigorously summarize and evaluate the evidence, but multiple factors have made such assessments difficult. The literature on tumor markers is plagued by nonpublication bias, selective reporting, and incomplete reporting. Several measures to address these problems are discussed, including development of a tumor marker study registry, greater attention to assay analytic performance and specimen quality, use of more rigorous study designs and analysis plans to establish clinical utility, and adherence to higher standards for reporting tumor marker studies. More complete and transparent reporting by adhering to criteria such as BRISQ [Biospecimen Reporting for Improved Study Quality] criteria for reporting details about specimens and REMARK [Reporting Recommendations for Tumor Marker Prognostic Studies] criteria for reporting a multitude of aspects relating to study design, analysis, and results, is essential for reliable assessment of study quality, detection of potential biases, and proper interpretation of study findings. Adopting these measures will improve the quality of the body of evidence available for comparative effectiveness research and enhance the ability to establish the clinical utility of prognostic and predictive tumor markers. J Clin Oncol 30:4223-4232. (C) 2012 by American Society of Clinical Oncology
引用
收藏
页码:4223 / 4232
页数:10
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