The Nation's Investment in Cancer Research

Empowering Cancer Research

Translating Research into Clinical Practice: Redefining Clinical Trials

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.

• Enhance coordination and cooperation by ensuring that comprehensive information on cancer clinical trials is readily available for all, that collaborative team science as well as individual achievements are rewarded, and that NCI clinical trials are effectively coordinated with federal regulatory systems.
• Enhance scientific quality and prioritization so that NCI supports the best-designed trials that address the most important questions, thereby leveraging significant scientific advances.
• Enhance standardization of tools and procedures for trial design, data capture, data sharing, and administrative functions to decrease effort and minimize duplication.
• Enhance operational efficiency by increasing the rate of patient accrual and reducing operational barriers so that trials can be conducted in a timely, cost-effective manner. In order to oversee implementation of the recommendations of the CTWG, an extramural advisory committee, the Clinical Trials Advisory Committee (CTAC), has been chartered. In addition, NCI has developed a coordinated, internal organizational structure to manage the entire clinical trials enterprise supported by the Institute. The Clinical Trials Operations Committee (CTOC) provides strategic oversight of the NCI's clinical trials enterprise while the Coordinating Center for Clinical Trials (CCCT) manages the implementation of the CTWG initiatives.

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.

NCI-Designated Cancer Centers

The NCI's Cancer Centers Program is a critical component of the Institute's effort to provide infrastructure and manpower support for NCI-sponsored extramural science. The Cancer Centers Program supports 63 NCI-designated Cancer Centers nationwide that are actively engaged in transdisciplinary research to reduce cancer incidence, morbidity, and mortality. The NCI-designated Cancer Centers are a major source of discovery of the fundamental nature of cancer and serve as a key mechanism for translating those discoveries to patient care. These Centers, as well as other cancer centers throughout the country, deliver medical advances to patients and their families, educate healthcare professionals and the public, and reach out to underserved populations.

The NCI-designated Cancer Centers are directed by some of the finest leaders in the cancer community. The Cancer Center Directors have spent much of the last year examining the opportunities that exist to further the fields of cancer prevention, early detection, cancer treatment, and survivorship. They have identified areas for collaboration and areas of particular need. Their recommendations are outlined in the report, "Accelerating Successes Against Cancer" and serve as a valuable resource to the cancer research community and the NCI. Their recommendations have been incorporated into our overall strategic plan and are reflected in our need to expand certain areas of research.

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