Improving Precision Oncology through Better Designs and Reporting of Biomarker-Driven Randomized Clinical Trials
A partir d'une revue de la littérature publiée entre 2011 et 2020, cette étude identifie des essais cliniques de phase III comportant des études de validation de biomarqueurs prédictifs (45 essais cliniques), analyse leur conception puis examine la façon dont sont présentés et utilisés les résultats obtenus
Considerable progress in understanding cancer biology and advances in technology bring us closer to making precision oncology a reality, as is demonstrated by the volume of novel molecularly-targeted and immune-modulating agents entering clinical development. However, integrating these agents into clinical practice requires validation of companion diagnostic (predictive) markers that can accurately separate patients into a biomarker-positive subgroup with a favorable benefit-risk profile and a biomarker-negative subgroup where the benefit-risk profile is unfavorable.
Journal of the National Cancer Institute , éditorial en libre accès, 2021