Exploiting the success and failure of cancer therapies: Investing now in accurate biomarker data to improve outcomes later

ED01-01

Most therapeutic clinical trials of anti-neoplastic agents are not designed to anticipate or exploit the most likely outcome: failure to meet the primary endpoint. In the vast majority of these trials, the reason for failure is poorly understood. Unfortunately, clinical studies are rarely structured for iterative analyses of cause-and-effect, a core principle of scientific investigation. However, several recent studies demonstrate the power and importance of recognizing tumor and host subtypes, and measuring drug effects at the target level. The advent of new tools for assessing biomarkers of tumor and host heterogeneity and drug response have provided unprecedented opportunities for refining concepts of success and failure in clinical trials. This presentation will highlight key advances and discuss issues in the accurate assessment of biomarkers in the context of the complexities of normal human variation and disease phenotypes.