Phase III Clinical Trials That Integrate Treatment and Biomarker Evaluation
Cet article analyse les biais d'interprétation des résultats d'essais cliniques de phase III intégrant l'évaluation d'un traitement anticancéreux et d'un biomarqueur
Many new anticancer agents are molecularly targeted and thereforemayonly benefit a subgroup of a histologically defined population. Development of these agents relies on biomarkers that identify a sensitive subpopulation (ie, the assumption is made that a binary biomarker can classify patients into two subgroups so that the agent works in one subgroup but not in the other)...
Journal of Clinical Oncology , résumé, 2013