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June 8, 2004 • Volume 1 / Number 23 E-Mail This Document  |  Download PDF  |  Bulletin Archive/Search  |  Subscribe

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Special ReportSpecial Report

Working Group to Refine NCI Clinical Trials Process

NCI has formed the Clinical Trials Working Group (CTWG) to advise the National Cancer Advisory Board (NCAB) on issues related to the institute's cancer clinical trials program. The CTWG is chaired by Dr. James Doroshow, director of NCI's Division of Cancer Treatment and Diagnosis; and is co-chaired by Dr. Howard Fine, chief of the Neuro Oncology Branch of NCI's intramural program, and Dr. Kenneth Buetow, director of NCI's Center for Bioinformatics. The CTWG's members include representatives from a broad range of oncology perspectives including the NCI intramural and extramural programs in cancer therapy and prevention, cancer centers, SPOREs, the clinical cancer cooperative groups, CCOPs, cancer patient advocacy groups, the pharmaceutical industry, the U.S. Food and Drug Administration, the Center for Medicare & Medicaid Services, and a variety of other clinical oncology disciplines.

The working group was charged by NCI Director Dr. Andrew C. von Eschenbach to advise the NCAB and its Subcommittee on Clinical Investigations on the development, conduct, infrastructure, and support necessary for the optimal coordination and future progress of NCI extramural and intramural clinical research trials including diagnosis, treatment, and prevention studies.

"Clinical trials are essential for the improvement of the quality of life of our patients and are a critical part of the research process," says Dr. Doroshow. "They allow basic scientific observations to progress from the laboratory to become the standard of care." There has never been a group specifically charged with the oversight of the clinical trials process throughout NCI. Using as its starting point the recommendations of NCI's Armitage Report and NCAB's P30/P50 Working Group Report, the CTWG will take on this task and will also develop a blueprint for a cancer clinical trials system of the future."

The goals of the CTWG include: establishing a process for the ongoing oversight of NCI-supported clinical trials; enhancing mechanisms for prioritizing clinical trial development; increasing the coordination of clinical trial activities across the entire spectrum of clinical trial venues supported by NCI in conjunction with the FDA, other governmental agencies, and the pharmaceutical industry; improving the timeliness of clinical trial completion, including regulatory issues that affect the rate at which studies can be implemented; and providing a blueprint for a clinical trials system for the future.

"A primary challenge in clinical cancer research is to effectively integrate experimental and clinical data, generated from different types of technologies, into a single system with a common language that cancer researchers can easily access," says Dr. Doroshow.

"To achieve this goal, clinical trial researchers must use a consistent, common language for managing and organizing information across the entire spectrum of clinical investigation, from early therapeutic studies to cancer prevention trials," Dr. Doroshow continues. "NCI's ability to develop informatics infrastructures linking investigators across the country and internationally is crucial to this working group's success. To that end, the CTWG will play an important advisory role in the development of caBIG. Major changes in bioinformatics will provide the enabling technology that will allow both patients and their physicians to participate in clinical trials more efficiently and with enhanced access. Thus, this technology really is the basis for considering how clinical trials of the future will be conducted."

CTWG will regularly communicate its mission, goals, and progress to the NCAB, its Subcommittee on Clinical Investigations, and other constituencies. These include NCI and other appropriate federal agencies; community oncologists; research institutions; cancer advocacy, voluntary, and professional organizations; clinical trial participants and patients; and the general public.

"Through these clinical trial constituencies, the CTWG will work to open intramural and extramural lines of communication," says Dr. Doroshow. "This will bring together a more diverse research community to improve the procedures and outcomes of clinical research."

For additional information on the CTWG and its activities, go to