Using these biomarker validation steps, features including high-grade prostatic intraepithelial neoplasia (HGPIN), PSA level, apoptosis and proliferation may be considered as surrogate endpoint biomarkers of PCa . In addition, Brown et al suggested that bone-related peptides like N- and C-terminal peptide fragments of type I collagen, and bone-specific alkaline phosphatase can be used as endpoint biomarkers in PCa . Despite the fact that the drug development pipeline is well established, biomarker validation pipeline is still a controversial subject among biomarker researchers. Through the efforts of the EDRN, Pepe et al have developed a 5-phased biomarker validation pathway [97, 102] that extends the ideas of Prensner et al : The first stage is the preclinical exploratory phase where promising potential biomarkers are identified; Phase II involves clinical assay and validation to identify disease establishment; Phase III is a retrospective longitudinal study for preclinical detection of disease; Phase IV involves a prospective screening of the characteristics and extent of disease; and Phase V is aims at cancer control by assessing the effect of screening with biomarker on the burden of disease in the population (Table 2). Several standard guidelines for reporting and evaluating biomarker studies have emerged: reporting recommendation for tumour markers (REMARK); biospecimen reporting for improved study quality (BRISQ); minimum information about a microarray experiment (MIAME); standard for reporting diagnostic accuracy (STARD); and the level of evidence (LoE) based tumor marker guideline (TMUG) proposed by the American Society of Clinical Oncology (ASCO) in 1996 . These guidelines have promoted transparency and rigour in the way biomarker discovery is being reported and evaluated; albeit most are yet to be implemented in African cancer biomarker studies.