Biomarkers that predict a patient's responsiveness to anticancer therapies are of increasing importance during drug development and in clinical trials, as well as in the clinic. In this Review, the major challenges to biomarker development and standardization are discussed, and the considerations for validation of the pre-analytical, analytical and post-analytical protocols involved in biomarker assays are highlighted.
- Armand de Gramont
- Sarah Watson
- Stanley R. Hamilton
