The enormous potential for more "personalized" cancer treatment, coupled with the complexity of evaluating new, highly specific therapeutic agents and diagnostic tests, demands a national clinical trials enterprise that integrates the knowledge, insights, and skills of multiple fields into a new kind of cross-disciplinary, scientifically-driven, cooperative research endeavor. Creating such an endeavor, endorsed by cancer centers across the U.S., will require greater integration of the successful, but functionally diverse, elements of the current clinical trials system supported by NCI.
To address this goal, the Clinical Trials Working Group (CTWG) of the National Cancer Advisory Board (NCAB) developed a detailed blueprint for "Restructuring the National Cancer Clinical Trials Enterprise." The strategy developed by the CTWG focuses on leveraging the unique strengths of the entire current NCI-supported clinical trials enterprise to bring about a system that is more effective, efficient, and facile.
This strategy specifically recognizes the role of NCI-designated Cancer Centers as a key institutional home for a large number of cancer clinical investigators, the strength of Specialized Programs of Research Excellence (SPOREs) in disease-oriented translational studies, the stable clinical trials infrastructure provided by the Cooperative Groups, and the ability of Community Clinical Oncology Programs (CCOPs) and other community oncologists to provide clinical trials in a local environment. The proposed restructuring preserves and strengthens all of the existing components of the NCI clinical trials system and enhances their ability to work together in fundamentally different ways.
The strategy developed by the CTWG addresses four important goals:Implementing the recommendations of the CTWG will require considerable effort by all stakeholders as well as financial investment on the part of NCI. This renewed commitment and the associated resources required are crucial for ensuring that the large, ongoing national investment in cancer clinical trials is effective and efficient in bringing effective new therapies to patients. By embracing this restructuring, NCI, cancer centers, and the oncology research community will be positioned to ensure that the advances in understanding the biological basis of cancer, generated by the past 40 years of research, are harnessed effectively to bring measurable, meaningful benefits to patients today and in the future.
Building on the plans outlined by the CTWG, NCI recently completed a two-year examination of early translational research and the opportunities and barriers that exist. The Translational Research Working Group (TRWG), a working group of the NCAB, was established to conduct a discussion with the broader cancer research community to develop recommendations about how NCI can best organize its investment to further translational research. The recommendations of this group were received by NCI in June, 2007, and the Institute is working on an implementation plan that integrates these activities with the infrastructure and support being created to support the CTWG.