The Biomarkers Consortium Launches I-SPY 2 Breast Cancer Clinical Trial
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THE BIOMARKERS CONSORTIUM LAUNCHES I-SPY 2 BREAST CANCER CLINICAL TRIAL
Highly Anticipated Multi-Agent Trial Opens at Major U.S. Medical Sites
Groundbreaking Public-Private Collaboration Combines Personalized Medicine and Novel Trial Design to Develop Potentially Life Saving New Breast Cancer Drugs
BETHESDA, MD – March 17, 2010 – The Biomarkers Consortium, a unique public-private partnership that includes the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH), and major pharmaceutical companies, led by the Foundation for the National Institutes of Health (FNIH), today announced the launch of a highly anticipated clinical trial to help screen promising new drugs being developed for women with high risk, fast-growing breast cancers—women for whom an improvement over standard treatment could dramatically change the odds of survival.
The I-SPY 2 trial will employ a groundbreaking clinical trial model that uses genetic or biological markers (“biomarkers”) from individual patients’ tumors to screen promising new treatments, identifying which treatments are most effective in specific types of patients. In addition, an innovative adaptive trial design will enable researchers to use early data from one set of patients to guide decisions about which treatments might be more useful for patients later in the trial, and eliminate ineffective treatments more quickly.
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http://www.biomarkerconsortium.org/
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