Clinical Trial Program Restructuring Advancing Quickly

A new NCI organizational structure, designed to oversee the institute's entire clinical trials enterprise, was unveiled today at the NCAB meeting.

The reorganization is the direct result of recommendations issued last June by the Clinical Trials Working Group (CTWG). At the NCAB meeting, Dr. James Doroshow, director of the Division of Cancer Treatment and Diagnosis and co-chair of CTWG, described the structural components that will support this effort, which include the Clinical Trials Advisory Committee (CTAC), Clinical Trials Operations Committee (CTOC), and the Coordinating Center for Clinical Trials (CCCT).

CTAC is an external oversight committee, governed by the provisions of the Federal Advisory Committee Act, that will advise the NCI Director on the institute's Clinical Trials Program and will include members of NCAB as well as other NCI advisory boards and additional cancer clinical trials experts. CTAC will oversee implementation of CTWG initiatives, including a review of the system to evaluate and measure the effects of the implementation. CTAC also will provide advice on the use of "correlative science funds," additional funding allotted to specific clinical trials for correlative science and quality-of-life studies.

CTOC is an internal NCI committee, chaired by the Deputy Director for Clinical and Translational Sciences, that includes the directors of every NCI division, branch, or center involved in clinical trials. Based in the NCI Director's Office, CTOC will coordinate clinical trials programs across NCI and will make recommendations to improve the cost-effectiveness and reduce duplication and overlap among NCI components involved in clinical trials. CTOC will also evaluate new Requests for Applications and Program Announcements for clinical trials prior to review by the NCI Executive Committee

Project management for the implementation of all CTWG initiatives will be provided by the Coordinating Center for Clinical Trials (CCCT). CCCT will support a number of significant activities, including coordinating new disease-specific steering committees for prioritization of phase III trials, the investigational drug steering committee for phase I and II trials, and working groups that will develop critical new tools for clinical investigators, as well as measures to improve clinical trial operational efficiency.

Two disease-specific cancer steering committees have begun to take shape. On January 26, the gastrointestinal steering committee met for the first time at the American Society of Clinical Oncology Gastrointestinal Cancer Symposium. The second steering committee, for gynecologic malignancies, began discussions at last month's Gynecologic Oncology Group meeting.

The CTWG implementation plan will help to integrate successful, but functionally diverse, elements of the current clinical trials enterprise. By embracing this restructuring, NCI and the cancer community will be positioned to ensure that advances in our understanding of the biological basis of cancer are rapidly translated into improved patient outcomes.