NCI Cancer Bulletin: A Trusted Source for Cancer Research NewsNCI Cancer Bulletin: A Trusted Source for Cancer Research News
June 7, 2005 • Volume 2 / Number 23 E-Mail This Document  |  Download PDF  |  Bulletin Archive/Search  |  Subscribe

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NCAB Approves Redesign of NCI Clinical Trials System

The National Cancer Advisory Board (NCAB) today formally accepted 22 strategic recommendations designed to reshape and enhance the National Cancer Institute's (NCI) clinical trials system.


NCI announces the formation of the Translational Research Working Group. See story.

The recommendations are included in a report, "Restructuring the National Cancer Institute Clinical Trials Enterprise." The report was developed by the Clinical Trials Working Group (CTWG), a panel of 40 stakeholders established by NCI Director Dr. Andrew C. von Eschenbach in 2004. NCAB's vote to accept the report sets in motion several major steps to implement the recommendations that were first presented to NCAB in February. The result is a series of initiatives that includes an implementation plan and budget.

CTWG Chair Dr. James H. Doroshow, director of NCI's Division of Cancer Treatment and Diagnosis (DCTD), presented the report to NCAB. "With these steps, we hope to integrate the best of NCI's current clinical trial system into a cross-disciplinary enterprise," said Dr. Doroshow. (See Spotlight for a detailed description of the CTWG recommendations or go to http://integratedtrials.nci.nih.gov.)

The recommendations emerged from a series of inclusive deliberations. CTWG gathered information for almost 18 months, accepting public comment and considering various ideas and suggestions on the key issues. On the CTWG Web site, 27 questions were posted to help frame and articulate the emerging issues. More than 2,200 replies were received from hundreds of clinical trial stakeholders, including academic clinical investigators; community medical oncologists; patient advocates; and representatives from government agencies, industry, and professional groups.

"Many NCI staff have worked on this effort," said Dr. John E. Niederhuber, NCAB chair. "This has been one of the largest undertakings I've ever been associated with in terms of the variety of people and organizations actively involved in the process. The process of developing this report was transparent and open to input from everyone with an interest in cancer clinical trials. The NCAB is extremely appreciative and very proud to approve this report. The Board looks forward to working with NCI to implement these initiatives."

The CTWG recommendations call for two significant structural changes in how NCI currently conducts and manages clinical trials. First, senior leadership from all NCI divisions will decide how best to marshal the resources from their scientists to contribute to more efficient clinical trials management within the institute.

Second, a permanent group - the Clinical Trials Oversight Subcommittee - will be established under NCAB to guide development of the new trials structure and evaluate the clinical trials enterprise. This group also will advise the NCI director about emerging clinical trials issues.

"Clinical oncology is entering a new age, driven by technology and basic molecular discoveries unimaginable a generation ago," said Dr. von Eschenbach. "NCI and the cancer research community must determine the best way to adapt clinical trials to meet these new challenges and opportunities. This report and its implementation plan represent a critical step to reaching the NCI goal of ending the suffering and death due to cancer by 2015."

Dr. von Eschenbach noted that research advances, particularly in molecular medicine, are beginning to transform the face of clinical oncology not only in the lab but also in the clinic. "What we have learned about the fundamental mechanisms of cancer is having a dramatic impact on the delivery end of the continuum," he said. "Targeted therapies represent a major step beyond the toxic treatments of the past, and in many cases might be matched to an individual patient's biological profile. These recommendations will help us fulfill that promise."

By Addison Greenwood