Research collaborative formed to explore biomarker use

The American Association for Cancer Research (AACR) has announced the formation of the AACR-FDA-NCI Cancer Biomarkers Collaborative to facilitate the use of validated biomarkers in clinical trials and, ultimately, their use in evidence-based oncology and cancer medicine. The collaborative includes researchers from academia, government, and industry, as well as patient advocacy groups.

“Major advances in cancer biology over the last quarter-century have provided us with a better fundamental understanding of cancer in all of its forms, yet the translation of this knowledge into medical practice remains painstakingly slow,” said William N. Hait, MD, PhD, president of AACR. “Therefore, we are joining forces with our partners to find new ways of exploring the use of biomarkers in cancer detection and treatment without sacrificing high standards for safety and efficacy.”

At its formation in November 2006, the group laid the groundwork for the collaborative and identified four priority areas of research: biospecimens, bioinformatics, assay validation, and information sharing. This summer, they will begin to develop guidelines for integrating predictive biomarkers into clinical trials. These guidelines will inform policies that are a part of the Critical Path Initiative, the FDA's effort to modernize the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery or “proof of concept” into a medical product.