LOS ANGELES –The American Association for Cancer Research, together with the Food and Drug Administration and National Cancer Institute, today announces the formation of the AACR-FDA-NCI Cancer Biomarkers Collaborative (CBC) to facilitate the use of validated biomarkers in clinical trials and ultimately in evidence-based oncology and cancer medicine.
The Collaborative brings together leaders from academia, government, industry, and patient advocacy groups to develop a set of guidelines for effectively integrating predictive biomarkers into clinical trials.
"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, M.D., Ph.D., President of the American Association for Cancer Research. "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."
"The FDA's Critical Path is an important initiative that aims to modernize the processes and methods used to evaluate the safety, efficacy and quality of medical products as they move from product selection and design to mass manufacture," said Samir Khleif, M.D., of the NCI and Special Assistant to the FDA Commissioner.
The Collaborative evolved from a special "Think Tank" session of academic, industry and government researchers and patient advocacy groups held at AACR's headquarters in Philadelphia in November, 2006. Think Tank participants laid the groundwork for the new collaborative and identified four priority areas of research to focus on: biospecimens, bioinformatics, assay validation, and information sharing.
This summer, the Collaborative will meet again in Philadelphia to discuss various aspects of these four areas as they relate to biomarker validation and to 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.
"We believe that the CBC will address the mission of the AACR, the goals of the NCI, and the FDA's Critical Path Initiative and will make a major contribution to the success of a new generation of clinical trials and to progress in cancer drug development, " said James H. Doroshow, M.D., Director of NCI's Division of Cancer Treatment and Diagnosis.
The mission of the American Association for Cancer Research is to prevent and cure cancer. Founded in 1907, AACR is the world's oldest and largest professional organization dedicated to advancing cancer research. The membership includes more than 25,000 basic, translational, and clinical researchers; health care professionals; and cancer survivors and advocates in the United States and more than 70 other countries.
AACR marshals the full spectrum of expertise from the cancer community to accelerate progress in the prevention, diagnosis and treatment of cancer through high-quality scientific and educational programs. It funds innovative, meritorious research grants. The AACR Annual Meeting attracts more than 17,000 participants who share the latest discoveries and developments in the field. Special Conferences throughout the year present novel data across a wide variety of topics in cancer research, treatment, and patient care.
AACR publishes five major peer-reviewed journals: Cancer Research; Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular Cancer Research; and Cancer Epidemiology, Biomarkers & Prevention. Its most recent publication, CR, is a magazine for cancer survivors, patient advocates, their families, physicians, and scientists. It provides a forum for sharing essential, evidence-based information and perspectives on progress in cancer research, survivorship, and advocacy.