Three Department of Health and Human Services agencies are working together for the first time to find biologic markers that could help improve cancer treatments.
In February 2006, the Food and Drug Administration; the National Cancer Institute (NCI), part of the National Institutes of Health (NIH); and the Centers for Medicare & Medicaid Services (CMS) announced the Oncology Biomarker Qualification Initiative (OBQI)--an agreement to collaborate on biomarker development and evaluation.
Biomarkers are biologic indicators of disease or therapeutic effects, which can be measured through dynamic imaging tests and tests on blood, tissue, and other biologic samples.
"An enhanced understanding of clinical biomarkers will help make the development of diagnostics and treatments more targeted, one of our most pressing goals under the Critical Path Initiative, FDA's program to modernize the medical product development process," says Acting FDA Commissioner Andrew C. von Eschenbach, M.D. "We believe partnerships that help us standardize the use of new technologies are essential to refining the drug development process so we can bring personalized medicines to patients more quickly and ultimately improve outcomes."
The collaboration will develop scientific understanding of how biomarkers can be used to assess the impact of therapies and better match therapies to patients. For instance, OBQI will address questions such as how particular biomarkers can be used to
- assess after one or two treatments whether a patient's tumor is responding to treatment
- determine more definitively whether a tumor is dying, even if it is not shrinking
- identify which cancer patients are at high risk of their tumor coming back after therapy
- determine whether a patient's tumor is likely to respond at all to a specific treatment
- efficiently evaluate whether an investigational therapy is effective for tumor treatment.
The goal of OBQI is to validate particular biomarkers so that they can be used to evaluate new, promising technologies in a manner that will shorten clinical trials, reduce the time and resources spent during the drug development process, 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," says NIH Director Elias A. Zerhouni, M.D. "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."
Under OBQI, biomarker research will be focused in four key areas: standardizing and evaluating imaging technologies to see in more detail how treatments are working, developing scientific bases for diagnostic assays to enable personalized treatments, instituting new trial designs to use biomarkers, and pooling data to ensure that key lessons are shared from one trial to another. By working with academic and industry scientists, as well as with professional organizations, the OBQI teams can foster the development of key information on biomarkers through clinical trials.
"By identifying biomarkers for specific cancers and clinically evaluating them, researchers will have an evidence base for their use in targeted drug development and to determine which therapies are likely to work for patients before treatment selection," says NCI Deputy Director Anna D. Barker, Ph.D. "Rather than waiting weeks to months to determine if a specific drug works for a patient, biomarkers could be used to monitor real-time treatment responses."
The first OBQI project will serve to validate and standardize the use of Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) scanning. PET scans are used to characterize biochemical changes in a cancer. Under the collaboration, researchers will use FDG-PET imaging technology in trials of patients being treated for non-Hodgkin's lymphoma to determine whether FDG-PET is a predictor of tumor response. Data resulting from this type of evidence-based study will help both the FDA and the CMS work with drug developers based on a common understanding of the roles of these types of assessments.
"There are many steps between a novel scientific idea with tremendous promise and a new drug reliably benefiting patients," says CMS Administrator Mark B. McClellan, M.D., Ph.D. "This collaboration will produce evidence that will help people with Medicare and Medicaid get better care more quickly, as a result of better-targeted treatment decisions for cancer patients."
Over the next several months, the OBQI team will design a number of initiatives to identify and clinically qualify other cancer biomarkers. The new initiatives will bring together scientists from many sources and will address agency priorities identified through the FDA's Critical Path and the NIH's Roadmap Initiatives.
OBQI also represents the work of the NCI-FDA Interagency Oncology Task Force (IOTF). The IOTF is a collaboration between the NCI and the FDA to enhance the efficiency of clinical research and the scientific evaluation of new cancer treatments.
The FDA's Critical Path
Critical Path is the FDA's premier initiative to identify and prioritize the most pressing medical product development problems and the greatest opportunities for rapid improvement in public health benefits. Its primary purpose is to ensure that basic scientific discoveries translate more rapidly into new and better medical treatments. New tools will lead to answers about how the safety and effectiveness of medical products can be demonstrated in faster timeframes with more certainty and at lower costs. Visit www.fda.gov/oc/initiatives/criticalpath/ for more information on the FDA's Critical Path.
The NIH Roadmap
The NIH Roadmap is a series of new initiatives designed to pursue major opportunities and gaps in biomedical research that no single NIH institute could tackle alone, but which the agency as a whole can address. The goals include making the biggest impact possible on the progress of medical research, and catalyzing changes that will transform new scientific knowledge into tangible benefits for public health. See www.nihroadmap.nih.gov for more on the NIH Roadmap.
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