Integrating predictive biomarkers and classifiers into oncology clinical development programs: an adaptive, evidence-based approach.

摘要

The future of oncology drug development lies in using predictive biomarkers to identify subsets of patients who will benefit from particular therapies. These technologies offer hope of enhancing the value of cancer medicines, and reducing size, cost, and failure rates in clinical trials. However, examples of failure of predictive biomarkers also exist. In these cases the use of biomarkers add cost and time, and increase complexity and narrow the treated population unnecessarily. A notable setback was the failure of using epidermal growth factor receptor (EGFR) expression to predict efficacy of EGFR directed antibodies.