Report identifies critical areas for biomarker development & strategies to accelerate the translation of cancer therapies to patients
Biological markers that indicate normal, or abnormal, processes in the body, or biomarkers, are central to the detection, diagnosis and management of cancer and hold vast potential for the development of effective new personalized cancer therapies. Unfortunately, the rate at which biomarkers are discovered far outpaces the rate at which that information is translated to patient benefit.
This challenge has been a primary focus of the Cancer Biomarkers Collaborative (CBC), a stakeholder-driven effort established by the AACR, in partnership with the U.S. Food and Drug Administration (FDA) and National Cancer Institute (NCI) in 2007 to facilitate the effective and efficient use of biomarkers during cancer therapy.
On July 1, the CBC published the "AACR-FDA-NCI Cancer Biomarkers Collaborative Consensus Report: Advancing the Use of Biomarkers in Cancer Drug Development," in Clinical Cancer Research. The report identifies eight critical areas for biomarker development 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.
This report is intended to inform and accelerate the Critical Path Initiative, an FDA effort to modernize the scientific processes and methods used to evaluate the safety, efficacy and quality of medical products, and the work of the cancer research community.
Additionally, the AACR recently submitted the CBC Consensus Report to the National Institutes of Health-FDA Joint Leadership Council as a model for interagency and community cooperation on identifying barriers, developing recommendations and creating action plans to align efforts and speed research for patient benefit. The council is overseeing a new collaborative initiative between the two agencies and recently sought public input on how to accelerate scientific innovation into effective treatments for patients.
More from the July Edition of the AACR Cancer Policy Monitor