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NCI, FDA Announce Two New Initiatives As Part of Strategic Partnership

At a Friends of Cancer Research meeting, National Cancer Institute (NCI) Director Andrew C. von Eschenbach, M.D., and Food and Drug Administration (FDA) Commissioner Mark McClellan, M.D., Ph.D, announced two new collaborative initiatives to facilitate the development and use of better cancer treatments. The initiatives include a new system for submitting investigational new drug (IND) applications electronically under the "Cancer Biomedical Informatics Grid (caBIG) project" (http://cabig.nci.nih.gov)

"In taking these important concrete steps, we are moving the NCI-FDA partnership from an idea to a working reality that will make a difference for patients," said von Eschenbach. "Our goal is to reduce the burden of cancer for all Americans through the improved development and delivery of safe, more effective therapies."

McClellan said, "We are working to get safe and effective cancer therapies to patients as quickly and inexpensively as possible. Using modern information technologies to make our processes more efficient is a key approach to achieving this goal."

Specifically, the new initiatives will:

  • Link cancer researchers around the U.S. electronically to the FDA, thereby reducing the time it takes for promising new drugs to be reviewed for testing in clinical trials. It is anticipated that electronic submission of data will allow patients to benefit from earlier access to clinical trials as a result of shorter FDA processing time of IND applications, which FDA must review before new drugs may be studied in humans. FDA currently reviews IND applications in 30 days or less.

  • Initiate Cancer Fellowship Training Programs aimed at developing a corps of physicians and scientists, expert in clinical research, the regulatory approval process, and translation of research breakthroughs to clinical practice.

These initiatives result from ongoing work from the two organizations' Interagency Oncology Task Force. The task force was established in May 2003 to improve the efficiency of all aspects of cancer drug development and regulatory review.

The FDA has agreed to work with NCI to develop clinical trial management software that makes it easier for cancer research groups and the FDA to work collaboratively. As a first step, NCI and FDA will work together to build tools that facilitate electronic interaction, focusing in particular on IND applications. The two organizations will work together to coordinate standards and develop tools to streamline regulatory interactions and accelerate the overall regulatory review process for new cancer drugs. These activities will become part of the NCI's cancer Biomedical Informatics Grid, in which the FDA has agreed to participate.

Under the new Fellowship Training Programs initiative, fellows will work in clinical oncology programs at NCI, where cutting-edge therapies are evaluated in patients. They will also work in the technical and regulatory review programs at the FDA, which reviews new drugs and diagnostics. As a result, fellows will bring state-of-the-art knowledge and technology to bear on the design, conduct, and review of clinical trials. These model programs will inform and harmonize all phases of cancer drug discovery, development, and regulatory review for the benefit of cancer patients.

The meeting, held at the Woodrow Wilson International Center for Scholars in Washington, D.C., features keynote addresses from Drs. McClellan and von Eschenbach on this new collaboration. NCI is part of the National Institutes of Health (NIH) and NIH and FDA are part of the Department of Health and Human Services.


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