Strategies to design clinical studies to identify predictive biomarkers in cancer research

Even though personalized oncology is widely perceived as an imminent reality, few anticancer drugs are currently prescribed based upon predictive biomarkers.[1] Moreover, despite outstanding advances in molecular biology, the clinical development of most anticancer drugs is still based on conventional randomized studies that aim to detect statistically significant clinical benefits in unselected patients. Several factors underlie this fact, including the complexity of cancer, but probably one major cause is the lack of a robust methodology to discover candidate biomarkers.

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