The Diagnostic and Biomarkers Statistical (DABS) Center

Guidelines

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

Pepe et al. published a commentary in JNCI outlining a formal structure to guide the process of biomarker development.

Key issues in design of a definitive validation study. These slides are adapted from a presentation to the FDA at a joint meeting of FDA/NCI February 15, 2007.

Pepe MS, Feng Z, Janes H, Bossuyt P and Potter J. Pivotal evaluation of the accuracy of a biomarker used for classification or prediction: Standards for study design Journal of the National Cancer Institute 100(20):1432-1438; 2008 PCMID: PMC2567415