Published guidelines on study design and reporting may be helpful to investigators conducting studies. Please inform us of additional documents containing guidelines that may be useful.

Reporting Standards

The STARD Initiative aims to improve the accuracy and completeness of reporting of studies of diagnostic accuracy in order to allow readers to assess the potential for bias in a study and to evaluate the generalisability of its results.

Development Process

The EDRN Data Monitoring and Coordinating Center published a commentary, The Journal of the National Cancer Institute, outlining a formal structure to guide the process of biomarker development for early detection of cancer. (Pepe MS, Etzioni R, Feng Z, et al. Phases of Biomarker Development for Early Detection of Cancer JNCI 2001 93:1054-1061).

Study Design

The EDRN Data Monitoring and Coordinating Center published guidelines for design of biomarker evaluation studies. These guidelines should be employed in discovery research too. The PRoBE guidelines are in Pepe MS, Feng Z, Janes H, et al. Pivotal evaluation of the accuracy of a biomarker used for classification or prediction: Standards for study design JNCI 2008 100:1432-1438; 2008 PMCID: PMC2567415

Pipeline Improvement

From the National Cancer Institute: Baker SG. Improving the biomarker pipeline to develop and evaluate cancer screening tests.  JNCI 2009, 101:1116-1119.