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Summary Vision

Enhance the best of all the components of the NCI-supported clinical trials system to develop a cooperative enterprise built on a strong scientific infrastructure and a broadly engaged coalition of critical stakeholders.

The enormous potential for more specific cancer treatment, coupled with the complexity of evaluating new, highly specific agents, requires 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 will require integration of the successful, but functionally diverse, elements of the current clinical trials system supported by the National Cancer Institute (NCI). The strength of the current system is that it involves many institutions across the public, private, and academic sectors as well as a broad cross-section of clinical investigators and other healthcare professionals. The challenge is to bring these diverse institutions and individuals together into an integrated and efficient, but innovative and responsive, enterprise for moving therapies to patients.

Restructuring the national clinical trials enterprise founded on the best science requires the achievement of four important goals.

  • Enhance coordination and cooperation by ensuring that comprehensive information on cancer clinical trials is readily available for all stakeholders, that collaborative team science, as well as individual achievement, is 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, there by leveraging the most 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.

To address these goals, the Clinical Trials Working Group (CTWG) of the National Cancer Advisory Board (NCAB) has 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 current clinical trials enterprise. It is a strategy that specifically recognizes the role of NCI-designated Cancer Centers as the primary 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 critical need for investigator-initiated clinical trials supported by Program Project (P01) and R01 grants, 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 these existing components of the NCI clinical trials system, but asks them to work together in fundamentally different ways.

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 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 these changes will require considerable effort by all stakeholders as well as new financial investment. But this renewed commitment and the associated resources are crucial for ensuring that the large, ongoing national investment in cancer clinical trials achieves the goal of bringing effective new therapies to patients. By embracing this restructuring, NCI and the oncology 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.

last modified 2007-05-22 12:44
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