• combine novel therapies developed by different sponsors,

  • develop therapies for rare diseases,

  • determine optimal duration and dose of treatment with drugs in clinical use,

  • test multimodality therapies, such as radiation therapy, surgery, or devices in combination with drugs,

  • study screening and prevention strategies, or

  • focus on rehabilitation and quality of life following therapy.

Publication of negative research findings about the therapies used in practice, which are underreported in the literature but which are essential in setting the standard of care, is also an important aspect of publicly funded research.

To address these needs, the National Cancer Institute (NCI) supports the largest U.S. network of clinical trials of any type through several different funding mechanisms. The largest component of that network is the Clinical Trials Cooperative Group Program (informally known as the Cooperative Group Program), which comprises 10 Groups that involve more than 3,100 institutions and 14,000 investigators who enroll more than 25,000 patients in clinical trials each year. Most Cooperative Group trials are either moderate-scale Phase II or large-scale Phase III clinical trials that may have practice-changing implications directly relevant to patient care. In contrast, many single-institution, investigator-sponsored trials are relatively small, nonrandomized Phase II trials that are less likely to have a major impact on the standard of care.

Since its inception in the 1950s, the Clinical Trials Cooperative Group Program has been instrumental in establishing the standards for cancer patient care and clinical research methods. The research undertaken by the Cooperative Groups has contributed to significant advances in cancer treatment and prevention, including the introduction of new treatments or new drug indications that have led to improved survival and increased cure rates, particularly for pediatric cancers and some early-stage cancers in adults. Furthermore, the role of the Cooperative Group Program is growing in importance as industry trials are increasingly being conducted outside of the United States. The Cooperative Group Program provides a primary mechanism by which the value of therapeutic agents can be assessed within the medical milieu of the U.S. health care system.

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. In addition, Cooperative

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