Overview

Clinical Trials Working Group

National Cancer Institute

The Clinical Trials Working Group was established in January, 2004, by Dr. Andrew von Eschenbach to advise the National Cancer Advisory Board’s Clinical Investigations Subcommittee on issues concerning NCI-supported cancer clinical trials. Dr. von Eschenbach’s formal charge to the working group requests advice on the development, conduct, infrastructure, and support necessary for the optimal coordination and future progress of the entire range of intramural and extramural clinical research trials supported by the National Cancer Institute, including diagnosis, treatment, and prevention studies.

The CTWG is broadly constituted with experts from academic research institutions; the pharmaceutical industry; cancer patient advocacy groups; NCI, NIH and other government agencies such as FDA and CMS; and leaders from major grant and cooperative-agreement programs supported by the NCI including the Cooperative Groups; specialized programs of research excellence (SPOREs); the Cancer Community Oncology Program (CCOP); and NCI-designated Cancer Centers.

The Clinical Trials Working Group began in January, 2004 with a review of the 1996 Armitage Committee Report and subsequent efforts by the NCI to carry out its recommendations. The CTWG used these earlier efforts to inform its discussions of questions and issues in clinical trials research. Using monthly conference calls, and quarterly face-to-face meetings, the CTWG has continued to identify and describe the most critical issues that affect the conduct of clinical studies, and to search for and develop possible models for making major improvements in the system. Above all, a primary objective of the CTWG is to ensure that the actions and processes necessary to improve the clinical trials system are carried out.

Progress of the CTWG is reported by the chairman, Dr. James Doroshow, to the National Cancer Advisory Board Clinical Investigations Subcommittee and to the full NCAB during its main meeting sessions that are open to the public. Content of open sessions is posted on the website of the Division of Extramural Activities, NCI. Information about the CTWG is published on the NCI’s Integrated Trials website [https://webarchive.library.unt.edu/eot2008/20090131052606/http://integratedtrials.nci.nih.gov]. This site contains Dr. von Eschenbach’s charge to the CTWG, the list of members, NCI articles on the CTWG, NCAB slide presentations, and tapes of actual presentations to the NCAB.

The Clinical Trials Working Group will complete its responsibilities as an advisory group to the NCAB Clinical Investigations Subcommittee by June 2005. The NCI plans to continue the work of the CTWG as a continuous, ongoing effort through a subcommittee to be established with outside representatives and rotating membership. Specifics of this subcommittee are yet to be determined.