Adeoye, John, Wan, Chi Ching Joan, and Thomson, Peter (2020) An appraisal of pivotal evaluation designs in validating noninvasive biomarkers for head and neck cancer detection. Acta Oncologica, 59 (12). pp. 1500-1502.

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Abstract

[Extract] Obtaining consensual molecular markers for contemporary clinical practice to diagnose head and neck cancer subtypes remains an all-important cause in diagnostic oncology. Biofluid specimens obtained noninvasively have seemed the more likely of the lot for clinical application with major advantages that centers on repeatable collection and representativeness of the diverse phenotypic profile of head and neck tumors [Citation1,Citation2]. With many promising biofluid markers being proffered in scientific reports [Citation3–5], concerns exist regarding the scientific rigor utilized in these biomarker validation endeavors as conventional case–control and retrospective methods are laden with systematic biases that reports’ validity. In 2008, the Early Detection Research Network (EDRN) proposed the prospective-specimen-collection retrospective-blinded evaluation (PRoBE) method for pivotal evaluation of biomarker classification accuracy [Citation6,Citation7]. This modality, which may well represent the most-thorough biomarker validation design available (that mimics real-world application), incorporates a nested case–control approach that proposes biofluid sampling before undertaking confirmatory diagnostic tests. Furthermore, the design requires the evaluation of disease-specific or preferential indicators without knowledge of cancer status or otherwise [Citation7]. In essence, evaluating the current practice of the PRoBE method will be tantamount to assessing the state of bedside readiness for the many biofluid markers suggested for head and neck cancer diagnosis. Hence, this brief report aims at mapping the utilization of the PRoBE protocol for research endeavors involving head and neck cancer biomarkers in noninvasive samples.

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