The Cancer Biomarkers Collaborative (CBC), a joint project of the American Association for Cancer Research, the FDA and the National Cancer Institute (NCI), is one of a number of collaborations designed to integrate biomarkers into drug development. The CBC will draft guideline recommendations for the FDA’s Critical Path Initiative in the following areas: collecting biospecimens and integrating them into clinical trials, identifying and validating biomarker assays for clinical trials, developing a model for precompetitive information sharing, and making use of information technology to improve the integration of biomarkers into clinical trials. Other needs indicated by experts are FDA guidance for companion diagnostics—when a specific biomarker assay is used to determine the efficacy or toxicity of a drug—and a pathway towards the simultaneous development of biomarkers and new drugs. Other organizations engaged in similar activities include the NCI’s Early Detection Research Network and the Severe Adverse Event Consortium.

Source: Clinical Laboratory News

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