The National Cancer Institute (NCI) announced recently that it is expanding access to its clinical trials to more oncologists around the country. This new policy will allow 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 the 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 participate 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, MD, 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."
Streamlining the Clinical Trials Process
Through the Web-based CTSU, oncologists are able to download protocols, case report forms, and other documents associated with trials. In addition, 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 is available.
"Since July of 2000, the US 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, md, president of the Coalition of National Cancer Cooperative Groups, which has worked with the 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 ability to meet all regulatory requirements and collect research data successfully.