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NCI, FDA, AACR Plan to Create Cancer Biomarker Guidelines

NEW YORK (GenomeWeb News) — Researchers working with biomarkers may soon see a new set of guidelines that will cover how biomarkers should be used in clinical trials, the America Association for Cancer Research said last week.
The guidelines will be co-developed by the National Cancer Institute, the US Food and Drug Administration, the AACR, and a group of representatives from academia, industry, and patient advocates, as part of a group dubbed the Cancer Biomarker's Collaborative.
AACR President William Hait said the translation of knowledge about cancer to "medical practice remains painstakingly slow." He said the AACR “is 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 guidelines, which will become part of the FDA's Critical Path Initiative, will focus on biospecimens, bioinformatics, assay validation, and information sharing. It could also include standardized procedures for processing and handling tissues, and a standardized bioinformatics platform to allow for greater data sharing.
The CBC "evolved" from a think-tank meeting of different groups that took place last November. The CBS’s four subcommittees, one for each area of focus, plan to meet independently this summer in Philadelphia to develop the guidelines, said Kimberly Sabelko, senior program administrator in the AACR’s executive office.
The entire CBC will meet again in the fall “to build a consensus on these four issues and hopefully to begin to draft a guidance document that will facilitate the use of validated biomarkers in clinical trials,” Sabelko wrote to GenomeWeb Daily News in an e-mail.
Sabelko said that some issues, including information sharing, IP, and clinical trial design, that are “extremely complex” and “may require” more than one subcommittee meeting to resolve.”
James Doroshow, director of NCI's Division of Cancer Treatment and Diagnosis, said the CBC will address the missions of all the federal bodies, and will make a "major contribution to the success of a new generation of clinical trials and to progress in cancer drug development."
“We have all this technology, we have the biomarkers and drug targets, but right now we’re not able to bring them all together,” Sabelko added in her e-mail.

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