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Biomarker Standardization to Play Role in NCI s Plan to Revamp Cancer Clincial Trials

NEW YORK, June 8 (GenomeWeb News) - In its ongoing effort to "revamp" its clinical trial program, the National Cancer Institute approved suggestions to develop methods to standardize the way biomarker data are measured, analyzed, and reported, according to the institute.


The effort is part of a broader announcement by the NCI stating that its National Cancer Advisory Board had accepted 22 proposals friom the Clinical Trials Working Group outlining steps the NCI can take to improve the institute's cancer clinical trials system. The CTWG's proposal also includes a five-year plan to accomplish the changes.

Among the proposed changes, the CTWG suggests that the NCI should "develop a standards-setting process for the measurement, analysis, and reporting of biomarker data in association with clinical trials to enhance data comparisons, reduce duplication, and facilitate data submission for regulatory approval," according to a statement released by the institute yesterday.

"Advances in molecular medicine are the driving force behind the Clinical Trials Working Group recommendations," the NCI said in the statement. "These advances offer enormous potential to improve cancer clinical practice by advancing beyond the toxic treatments of the past, but also create new challenges for the design and conduct of cancer clinical trials."
The CTWG's report, which can be found here, includes an implementation plan with a timeline and budget for each of the 22 initiatives.

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