background in the golestan cohort study that was launched to investigate the causes of esophageal cancer, a complete biospecimen bank was established for storage of collected blood, urine, hair, and nail samples. the objective of this study was to evaluate the feasibility of nail samples as a biomarker of selected trace elements status. methods thirty toenail samples were selected randomly from...

How can we encourage the application of novel genomic biomarkers in drug development? A major step in this direction would be a consensus on how to interpret results from measurements of these biomarkers in regulatory submissions. A transparent process for genomic biomarker validation would be of value both for the pharmaceutical industry as well as for regulatory agencies associated with it. A...

The introduction of new anticancer drugs into the clinic is often hampered by a lack of qualified biomarkers. Method validation is indispensable to successful biomarker qualification and is also a regulatory requirement. Recently, the fit-for-purpose approach has been developed to promote flexible yet rigorous biomarker method validation, although its full implications are often overlooked. Thi...

The developmental pathway from discovery to clinical practice for biomarkers and biomarker-directed therapies is complex. While several issues need careful consideration, two critical issues that surround the validation of biomarkers are the choice of clinical trial design (which is based on the strength of the preliminary evidence and marker prevalence) and the biomarker assay related issues s...

The role of biomarkers in drug discovery and development has gained precedence over the years. As biomarkers become integrated into drug development and clinical trials, quality assurance and, in particular, assay validation become essential with the need to establish standardized guidelines for analytic methods used in biomarker measurements. New biomarkers can revolutionize both the developme...

This review discusses data analysis strategies for the discovery of biomarkers in clinical proteomics. Proteomics studies produce large amounts of data, characterized by few samples of which many variables are measured. A wealth of classification methods exists for extracting information from the data. Feature selection plays an important role in reducing the dimensionality of the data prior to...

Currently available biomarkers, such as those used to diagnose myocardial infarction (e.g., cardiac troponins), were identified in the course of targeted physiologic studies. Similarly, basic investigation of diseases has largely been characterized by studies of isolated molecules in cellular systems. Advances in genomics technologies, however, are beginning to permit characterization of global...

A tumour biomarker is a characteristic that is objectively measured and evaluated in tumour samples as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. The development of a biomarker contemplates distinct phases, including discovery by hypothesis-generating preclinical or exploratory studies, development and qualificati...