NCI Annual Report for 2003

The National Cancer Institute and the Food and Drug Administration are sharing expertise and resources to streamline cancer drug development and bring safe, better medications and diagnostics to cancer patients more quickly.

The NCI/FDA Oncology Task Force, a group of senior staff from both agencies, will oversee implementation of the partnership, which announced two initiatives in November 2003:

Cancer fellowship training programs to develop a corps of physicians and scientists who are expert in clinical research and the regulatory approval process. Fellows will work in clinical oncology programs at NCI as well as in the technical and regulatory review programs at the FDA. Fellows will bring state-of-the-art knowledge to bear on the design, conduct, and review of clinical trials.

A new system for submitting investigational new drug (IND) applications electronically. The FDA must review IND applications before new drugs can be studied in humans. Electronic submission will lead to shorter FDA processing time, thereby giving cancer patients earlier access to clinical trials of new drugs. The system will be run through another new NCI program called caBIG (Cancer Biomedical Informatics Grid). caBIG will build a biomedical informatics network to connect teams of cancer investigators, their data, and their research tools. Fifty NCI-designated Cancer Centers are participating in a feasibility test of caBIG. This platform will allow research groups to tap into the rich collection of emerging cancer research data while supporting their individual investigations as well.

"The FDA is committed to finding better ways to get safe and effective treatments to patients with life-threatening diseases as quickly as possible," said former FDA Commissioner Mark McClellan, M.D., Ph.D. "At a time when the opportunities to reduce the burden of cancer are greater than ever, sharing tools and resources with our colleagues at the National Cancer Institute will help us fulfill that mission."

"The collaboration will help the two agencies take full advantage of their combined knowledge base at a time when many new kinds of anti-cancer agents are in the pipeline," said NCI Director Andrew von Eschenbach, M.D. "Molecularly targeted drugs and other novel agents offer great promise, but they also present new challenges that require more collaboration between those involved in their discovery and development."

< Previous | Next >