The Food and Drug Administration (FDA), the National Cancer Institute (NCI), part of the National Institutes of Health, and the Centers for Medicare & Medicaid Services (CMS) today announced the Oncology Biomarker Qualification Initiative (OBQI) -- an agreement to collaborate on improving the development of cancer therapies and the outcomes for cancer patients through biomarker development and evaluation.

Biomarkers are biologic indicators of disease or therapeutic effects, which can be measured through dynamic imaging tests, as well as tests on blood, tissue and other biologic samples. This initiative is the first time these three Department of Health and Human Services (HHS) agencies have focused together on biomarkers as a way of speeding the development and evaluation of cancer therapies.

"We are excited about this effort to speed the development and delivery of new cancer treatments for patients," said Secretary of Health and Human Services 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 preventions to patients more rapidly."
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 if a patient's tumor is responding to treatment
* Determine more definitively if 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 if 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. 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, M.D.

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