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)
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
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.