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

Abstract

A B S T R A C TClinical 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.

Genomic Predictors of Outcome in Prostate Cancer

“…Approved principles of study design include blinded marker analyses and randomly selected cases (in retrospective studies) [55]. Study reporting may be negatively affected by several potential biases, and therefore adherence to standard criteria, such as Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK), is essential for providing evidence on the clinical utility of biomarkers in oncology [56]. The biomarkers to be included in clinical decision making have to provide additional independent prognostic information or additive value together with established clinical and pathologic variables in a multivariate setting like the Memorial Sloan Kettering Cancer Center or Cleveland Clinic nomograms or Cancer of the Prostate Risk Assessment Postsurgical (CAPRA-S) risk stratification for PCa.…”

Generating and evaluating evidence of the clinical utility of molecular diagnostic tests in oncology

“…Greater transparency will enable others to more easily assess these claims. [6][7][8][9] Although specific methodological recommendations related to AV were excluded from the scope of this guidance document, ensuring AV before the final assessment of CV is critical to improving the evidence base for MDx tests in oncology.…”

Appropriate use of tumour biomarkers for treatment with innovative drugs: A retrospective study

“…More recent investigations have shown that the presence of anaplastic lymphoma receptor tyrosine kinase translocations in lung cancer and the absence of Kirsten rat sarcoma viral oncogene homolog (KRAS) mutations in colorectal cancer can predict the benefit of crizotinib and anti-epidermal growth factor receptor antibodies, respectively. Considering the critical importance of prognostic and predictive tumour markers in making clinical decisions, they should be subject to the same evidence-based standards of medicine, including cost/utility analyses, as other medical interventions and practices (1).…”