© 1999 by Oxford University Press
Journal of the National Cancer Institute, Vol. 91, No. 4, 312,
February 17, 1999
© 1999 Oxford University Press
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:
- State-of-the-science meetings to stimulate ideas for multicenter (phase III) trials; these meetings will include not only investigators from NCI's Clinical Trials Cooperative Groups — the traditional source of ideas — but also clinical and basic scientists from academia and industry, patient advocates, and others. The first state-of-the-science meeting will take place in mid-1999.
- Disease-specific Concept Review Committees, which will approve or disapprove proposals for phase III trials. Any researcher may submit an idea, regardless of affiliation. A third of each Committee's members will be from NCI, a third from the Cooperative Groups, and a third from the advocacy community and investigators outside the Groups. Up to now, review has been centralized largely within NCI. The first Committee, for genitourinary and lung cancers, will meet in spring 1999.
- A national Network of physicians, who will be able, eventually, to enroll patients on any trial approved by the Concept Review Committees. This is in contrast to the current system where investigators are limited to their Group's trials. The Network will be piloted with genitourinary, lung, breast, and gastrointestinal cancers and adult leukemia. Initially only members of Cooperative Groups will belong to the Network, but, as the new system becomes established, others will be able to join.
- A Cancer Trials Support Unit (CTSU) to provide a uniform system of patient registration and data collection for all Network trials. A CTSU contract will be awarded through open competition this year to an organization equipped to provide state-of-the-art clinical trials communications and data management.
- A common informatics system, which will link Network physicians with the CTSU. The online system will include common forms, common data elements, and electronic interfaces between data centers and sponsors for easy updating and reporting.
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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