American Association for Cancer Research

AACR-FDA-NCI Cancer Biomarkers Collaborative

The AACR, in partnership with the Food and Drug Administration (FDA) and National Cancer Institute (NCI), formed the AACR-FDA-NCI Cancer Biomarkers Collaborative (CBC) to accelerate the translation of cancer therapeutics into the clinic by shaping the processes for the effective development of validated biomarkers and their use in clinical trials for maximum patient benefit.   

Paramount to the success of the CBC is that it seeks input from and develops consensus among distinguished experts and key stakeholders—academia, pharmaceutical and diagnostics industries, government agencies, regulators, and patient advocates—worldwide. The CBC currently consists of more than 120 experts in all areas of cancer biomarker research working in four committees to address the priority areas of biospecimens, assay validation, bioinformatics, and information sharing.

This stakeholder-driven effort will inform and accelerate the FDA’s Critical Path Initiative and the work of the broader cancer community. Through its work, the CBC has brought to the forefront many key issues with regard to biomarker development that need to be addressed. It has convened stakeholders from around the world to develop consensus on these important issues and continues to seek U.S. and international input. Furthermore, the CBC serves as a catalyst to initiate collaborative projects to implement solutions to improve biomarker validation and integration into clinical trials and, ultimately, into clinical use. Collectively, these efforts should not only improve the treatment of cancer, but also lead to advances in the treatment of other diseases in which biomarkers increasingly play important roles.

The CBC will rely on the ongoing, active participation of a broad spectrum of stakeholders to continue its work to accelerate progress along the critical path in oncology drug development and will leverage and complement the ongoing efforts of numerous other groups. 

 

SPOTLIGHT

AACR-FDA-NCI Cancer Biomarkers Collaborative Consensus Report: Advancing the Use of Biomarkers in Cancer Drug DevelopmentCBC consensus report cover

The AACR, together with the FDA and NCI, published its cancer biomarkers collaborative consensus report in the July 1st issue of Clinical Cancer Research. The report identifies eight critical areas for biomarker development—biospecimens, analytical performance, standardization and harmonization, bioinformatics, collaboration and data sharing, regulations, stakeholder education and communication, and science policy—and details 27 strategies to accelerate the translation of cancer therapeutics into the clinic by shaping the processes for the effective development of validated biomarkers and their use in clinical trials for maximum patient benefit.   

Read the full AACR-FDA-NCI Cancer Biomarkers Collaborative Consensus report.