Expanded Access to Trials, 5/02

National Institutes of Health

FOR IMMEDIATE RELEASE May 13, 2002 NCI Press Office (301) 496-6641

NCI Expands Treatment Trial Access to Patients and Oncologists Nationwide

The National Cancer Institute (NCI) today announced it is expanding access to its clinical trials to more oncologists around the country.

The new policy allows cancer patients anywhere in the United States to participate more easily in advanced (Phase III) treatment trials.

Under the new system, oncologists can become credentialed as investigators and then can enroll patients in trials through NCI's Cancer Trials Support Unit (CTSU).

Until now, the CTSU has been open only to members of NCI's Cooperative Groups. The CTSU makes it easier for oncologists and patients to take part in important trials that define the standard of care for lung, breast, prostate, colorectal, and other cancers.

"This expansion allows every practicing oncologist in the country the opportunity to take part in some of the most advanced cancer treatment research," said Jeffrey S. Abrams, M.D., NCI project officer. "Soon, patients who seek the new treatments available in clinical trials, whether they live in the largest metropolis or the smallest rural community, will not be forced to travel long distances to receive critical care."

Through the Web-based CTSU, oncologists are able to download protocols, case report forms, and other documents associated with trials.

Participating oncologists are reimbursed for research costs and their staffs can benefit from on-line educational opportunities developed by the CTSU for which continuing education credit (CEU) is available.

"Since July of 2000, the U.S. Cooperative Groups have been working with the CTSU to develop and test systems ultimately designed to streamline the clinical trials process for group physicians and their patients," said Robert L. Comis, M.D., president of the Coalition of National Cancer Cooperative Groups, which has worked with NCI to develop the CTSU.

"Expanding the opportunity for participation of interested physicians outside the Group structure through the CTSU is a bold, new strategy to broaden access, which will hopefully lead to more rapid trial completion while maintaining the high quality of care associated with clinical trial participation."

Interested physicians will undergo a two-phase application and credentialing process, including a site visit, to ensure their capability to meet all regulatory requirements and to collect research data successfully.

The CTSU will launch its new program May 18, 2002, to coincide with the American Society of Clinical Oncology (ASCO) annual meeting in Orlando, Fla.

For more information on the CTSU or to learn more about participating in the program, please visit www.ctsu.org or call 1-888-823-5923.

# # # For more information about cancer in general, please visit NCI's Web site at http://www.cancer.gov.

Remember we are NOT Doctors and have NO medical training.

This site is like an Encyclopedia - there are many pages, many links on many topics.

Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.