Oncologists who belong to the National Cancer Institute's (NCI's) Cooperative Groups can now register online for selected phase III studies in a pilot project intended to streamline and simplify many of the tasks associated with clinical trials. The online component of NCI's new Cancer Trial Support Unit (CTSU), http://www.ctsu.org, is now open, allowing Cooperative Group members to:

• Register for any CTSU trial that is sponsored by a Group other than their own (and which is not an Intergroup trial).

• Receive accrual credits for the Group to which they belong, regardless of trial sponsorship.

• Download protocols, case report forms, and other documents associated with trials.

• Receive updates as new trials are added to the system.

• Receive reimbursement for research costs via the CTSU.

Membership in and use of the CTSU is free of charge.

A menu of phase III trials is now accessible via the CTSU Web site, including important trials in prostate, breast, non-small cell lung, and colorectal cancer. More will be added regularly. Eventually, the CTSU will handle not only physician registration, but also online patient enrollment, data reporting, credentialing of new NCI investigators, training, and some auditing and regulatory matters through the developing online system.

"For investigators, the new CTSU means enhanced access to clinical trials and fewer redundant activities among the NCI-sponsored Cooperative Clinical Trials Groups," said Robert Comis, M.D., chair of the Coalition of National Cancer Cooperative Groups, Philadelphia.

The ultimate goal is to make it easier for a wide range of physicians to participate in NCI-sponsored trials. Depending on the outcome of the pilot project, the CTSU could open to physicians outside the Cooperative Groups in 2001.

"Bringing the CTSU online is a milestone in revamping NCI's clinical trials system," said Jeff Abrams, M.D., who is coordinating this and other components of the new framework. The restructured system is designed to make NCI-sponsored trials more streamlined, accessible, and open to innovation.

Besides the CTSU, other major components of the clinical trials framework include:

• State-of-the-Science workshops, with online information at http://www.conference-cast.com/webtie/sots/sots.htm , designed to stimulate ideas for phase III trials from a broad range of participants, including scientists from academia and industry, patient advocates, and other cancer care professionals.

• Concept Evaluation Panels for phase III trials by peer reviewers from both inside and outside the Cooperative Groups and NCI.

• National Network of Physician Partners, which, when operational, will enable qualified physicians in academic and community setting to enter patients on phase III trials via the CTSU.

More information on the new system and its components is available on the Web at http://www.cancer.gov/clinicaltrials/conducting/new-national-system.

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