enroll more than 25,000 patients in clinical trials each year. The results of Cooperative Group trials have steadily improved the care of patients with cancer in the United States and worldwide for more than 50 years.

One of the Program’s strengths is the extensive involvement of physicians and patients from the community setting. Participation by the diverse patient populations treated in the community setting helps to ensure that the results of clinical trials are meaningful to a broad segment of the U.S. population and provides these patients with access to promising, innovative therapies as they are developed and tested. The clinical trials conducted by the Cooperative Groups also provide a valuable mechanism for the training of clinical investigators.

However, despite these important contributions and a long record of accomplishments, the Cooperative Group Program is at a critical juncture. Numerous challenges threaten its ability to conduct the timely, large-scale, innovative clinical trials needed to improve patient care. With many iterative layers of oversight, the complex trials system has become inefficient and cumbersome. The average time required to design, approve, and activate a trial is 2 years and many of the trials undertaken are not completed. Furthermore, since 2002 funding for the Cooperative Group Program has decreased by 20 percent, whereas new knowledge of the molecular changes underpinning cancer and the use of predictive biomarkers in cancer therapy not only increase the potential impact of trials but also add to their complexity and cost.

The director of NCI asked the Institute of Medicine (IOM) to conduct a consensus study of cancer clinical trials and the Cooperative Group Program and to develop recommendations on how to improve the system. To address the charge, the IOM appointed a 17-member committee with a broad range of expertise and experience.

The committee concluded that a robust, standing cancer clinical trials network is essential to effectively translate discoveries into clinical benefits for patients. There are hundreds of cancer therapies in development and a continuous need for design and implementation of new clinical trials, so it would be highly inefficient to fund and develop infrastructures and research teams separately for each new trial. Thus, it is imperative to preserve and strengthen the unique capabilities of the Cooperative Group Program as a vital component in NCI’s translational continuum.

However, the current structure and processes of the entire clinical trials system need to be redesigned to improve value by reducing redundancy and improving the effectiveness and efficiency of trials. Numerous changes are needed, including an evaluation and justification of the unique contribution of each Cooperative Group and a shift in the primary focus of NCI from oversight to the facilitation of Cooperative Group trials. The Program



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