Biomarker enrichment strategies: matching trial design to biomarker credentials

摘要: The use of biomarkers to identify patients who can benefit from treatment with a specific anticancer agent has the potential both improve patient care and accelerate drug development. development targeted agents their accompanying frequently occurs contemporaneously, confidence in putative biomarker's performance might, therefore, be insufficient restrict definitive testing new subgroup biomarker-positive patients. This Review considers which clinical trial designs analysis strategies are appropriate for phase III, biomarker-driven, randomized trials, on basis pre-existing evidence that biomarker successfully will respond question. types interim monitoring these trials also discussed. In addition, enrichment based prognostic separate population into subgroups better worse outcomes, regardless treatment, described. Finally, possibility formally using during II development, select what type biomarker-driven strategy should used III trial, is