Impact of biomarkers on clinical trial risk.

The last decade has witnessed the cost of drug development rise dramatically; concurrently, the number of new drug approvals has declined. Clinical trial failure rates have contributed significantly to this 'innovation' crisis and are directly related to clinical trial risk. One strategy that is often touted to resolve this challenge depends on embracing a personalized medicine approach where treatment is tailored to a patient's unique genetic background. We highlight a new risk-based paradigm of clinical trial risk that evaluates the utility of biomarkers in drug development and their risk mitigation benefits. Furthermore, examples elucidating the current state of biomarker integration during clinical trials and the potential risks posed by doing so will be discussed.