DOI: 10.1097/01.COT.0000294583.93196.8e
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Issn Print: 0276-2234
Publication Date: 2006/04/10
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Excerpt
“We are excited about this effort to speed development and delivery of new cancer treatments,” said HHS Secretary Mike Leavitt. “By bringing together the scientific, regulatory, and delivery expertise of these three agencies, we can bring targeted, more personalized cancer diagnostics, treatments, and prevention to patients more rapidly.”
The initiative will address how biomarkers can be used to assess the effect of therapy and better match treatment to patients. For example:
The goal is to validate particular biomarkers so they can be used to evaluate new, promising technologies in a manner that will shorten clinical trials, reduce the time and resources spent during drug development, improve the linkage between drug approval and drug coverage, and increase the safety and appropriateness of drug choices for cancer patients.
“Almost four years ago, NIH set out to create a roadmap for 21st century medical research. Programs like OBQI will be central to that vision, not only because they will lead to vital discoveries about the biology of disease, but because they will be models for scientific collaboration,” said NIH Director, Elias A. Zerhouni, MD.
Andrew C. von Eschenbach, MD, FDA Acting Commissioner, agreed. “An enhanced understanding of clinical biomarkers will help make development of diagnostics and treatments more targeted, one of our most pressing goals.”
The biomarker research will focus on four key areas:
The first project will validate and standardize use of fluorodeoxyglucose (FDG)-positron emission tomography (PET) scanning to characterize biochemical changes in a cancer—this time non-Hodgkin's lymphoma with FDG-PET as a predictor of tumor response.
