NEWS

NCI Overhauls Clinical Trials System

The National Cancer Institute will launch its new clinical trials system this year, giving researchers their first encounters with a framework that changes dramatically the way NCI's large, multicenter treatment trials are proposed, reviewed, and coordinated. The innovations will begin with pilot programs in genitourinary and lung cancers, said Jeff Abrams, M.D., who is overseeing implementation of the new system.

The changes grew out of NCI's scrutiny of its entire treatment trials program, according to Michaele Christian, M.D., who introduced the innovations to the National Cancer Advisory Board in December. Christian said the fundamental reasons for the scrutiny were recent rapid advances in biomedicine and trends in health care, both of which are challenging the clinical research establishment to make trials more efficient, open to innovation, and accessible.

To design the new system, NCI formed a Cancer Clinical Trials Review Group with 30 experts, all from outside NCI, who made nearly four dozen recommendations. Robert Wittes, M.D., director of NCI's Division of Cancer Treatment and Diagnosis, then charged a Clinical Trials Implementation Group, whose members came from both inside and outside the Institute, to create an action plan. Major elements of this plan include:

More information on the new clinical trials system is available on the NCI Web site for clinical trials, http://cancertrials. nci.nih.gov. A brochure describing the system is also available by calling NCI's Cancer Information Service at 1-800-4-CANCER.



             
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