The National Cancer Advisory Board (NCAB), within the last 4 years, has convened two broad-based panels to examine early and late translational research at NCI. The Clinical Trials Working Group (CTWG; http://integratedtrials.nci.nih.gov/ict/CTWG_report_June2005.pdf) reported its findings to the NCAB in 2005 and the Translational Research Working Group (TRWG; http://www.cancer.gov/aboutnci/trwg/finalreport.pdf) put forth its recommendations in 2007. The NCAB approved the findings of both groups, and important progress is being made in the implementation of these recommendations.
The CTWG focused on late translational studies, primarily phase III clinical trials, and the TRWG addressed early translational research, chiefly work done to move basic research discoveries into phase I and phase II clinical studies. The CTWG report recommended extensive changes to the NCI-supported clinical trials system that included establishing several committees that now play an important role in how NCI clinical trials are prioritized and initiated. This new infrastructure paved the way for the implementation of two of the TRWG recommendations.
Under the auspices of CTWG, NCI established the internal Clinical Trials Operating Committee (CTOC), which the TRWG recommended be expanded to include translational research. That change has occurred and the committee is now known as the Clinical and Translational Research Operations Committee, or CTROC. This committee is designed to coordinate clinical trials and translational programs across the institute and to make recommendations to improve cost-effectiveness and reduce duplication and overlap among NCI components. CTROC will also evaluate new Requests for Applications and Program Announcements in these research areas prior to review by the NCI Executive Committee.
The CTWG report recommended the formation of a Clinical Trials Advisory Committee (CTAC), an external oversight committee that oversees the implementation of CTWG initiatives, including the system to evaluate and measure the effects of the implementation. Following the recommendations of the TRWG, NCI has now expanded this committee to include oversight of translational research and the implementation of the TRWG recommendations. CTAC retains its acronym but now stands for the Clinical and Translational Advisory Committee.
The TRWG report, along with the CTWG changes, have expanded the role of the recently created Coordinating Center for Clinical Trials (CCCT) (http://ccct.nci.nih.gov/). The center now includes a Translational Research Support Office. CCCT is managing the implementation of all CTWG and TRWG initiatives.
Progress continues in other areas affected by the recommendations of both working groups. The CTWG called for the development of disease-specific scientific steering committees. To date, steering committees have been established in the following areas: gastrointestinal cancer; gynecologic cancer; genitourinary cancer; head and neck cancer; patient advocacy; and symptom management and health-related quality of life. The lung cancer steering committee is currently in development. These steering committees prioritize phase III concepts for therapeutic clinical trials and convene State-of-the-Science meetings to prioritize strategies for NCI-supported clinical trials.
Another major initiative recommended in the CTWG report was the development of a comprehensive database of NCI-supported clinical trials. The pilot phase of the project will begin in summer 2008. The development of this database is being spearheaded by the NCI Center for Biomedical Informatics and Information Technology, in collaboration with DCTD, CCCT, as well as NCI’s Division of Cancer Prevention, Office of Communications and Education, and the Cancer Centers Program.