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
- 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
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.