Revisiting the Standard Blueprint for Biomarker Development to Address Emerging Cancer Early Detection Technologies
Cet article présente les différentes phases de développement des biomarqueurs du réseau "Early Detection Research Network" piloté par le "National Cancer Institute", analyse comment adapter ces phases de développement pour évaluer rigoureusement les nouveaux biomarqueurs de détection précoce des cancers, identifie les dangers et les opportunités qui découlent d'une évaluation accélérée des biomarqueurs puis examine la manière dont les modélisations informatiques peuvent être exploitées pour mieux connaître les effets du dépistage et répondre aux besoins du moment
Novel liquid biopsy technologies are creating a watershed moment in cancer early detection. While evidence supporting population screening is nascent, a rush to market the new tests is prompting cancer early detection researchers to revisit the standard blueprint established by the Early Detection Research Network (EDRN) for evaluating novel screening biomarkers. In this commentary, we review the EDRN’s Phases of Biomarker Development (PBD) for rigorous evaluation of novel early detection biomarkers and discuss both hazards and opportunities involved in expedited evaluation. According to the PBD, for a biomarker-based test to be considered for population screening: (1) test sensitivity in a prospective screening setting must be adequate, (2) the shift to early curable stages must be meaningful, and (3) any stage shift must translate into clinically significant mortality benefit. In the past, determining mortality benefit has required lengthy randomized screening trials, but interest is growing in expedited trial designs with shorter-term endpoints. Whether and how best to use such endpoints in a manner that retains the rigor of the PBD remains to be determined. We discuss how computational disease modeling may be harnessed to learn about screening impact and meet the needs of the moment.
Journal of the National Cancer Institute , article en libre accès, 2022