Multi-Center Phase III Clinical Trials and NCI Cooperative Groups. Workshop Summary


Note: Proceedings contain the opinion of the presenters, but do NOT reflect the conclusions of the Health and Medicine Division or the National Academies. Learn more about the differences between Reports and Proceedings.

The National Cancer Institute's (NCI) Cooperative Group Program is one of the primary venues for the conduct of cancer clinical trials. The cooperative groups collectively recruit roughly 22,000 patients in more than 1,700 institutions to participate in multi-center clinical trials each year. Compared to industry clinical trials, the Cooperative Group Program conducts more trials focused on the best management of disease rather than on specific agents, and includes trials on cancer prevention, early detection, and comparative effectiveness.

The NCI-sponsored cooperative groups have made important contributions to improving treatment for many types of cancer, including breast, ovarian, colorectal, and childhood cancers. Cooperative group research has been instrumental in establishing innovative treatments that improve outcomes and quality of life. Despite these successes, the Cooperative Group Program has faced a number of challenges that threaten its effectiveness, including cumbersome, complex processes that have created inefficiencies, flat budgetary allocations, and lagging patient and physician participation.    

To address this problem, the National Cancer Policy Forum (NCPF) convened a workshop titled "Multi-Center Phase III Clinical Trials and NCI Cooperative Groups" in Washington, DC, on July 1-2, 2008. The purpose of the workshop was to outline the challenges that the public clinical cancer research enterprise faces, and to identify possible solutions to these challenges.

The proceedings of this workshop will serve as an input to an IOM committee examining the role of the NCI cooperative groups in the conduct of cancer clinical trials. That committee's consensus report is scheduled for release in spring 2010.