ORGANIZATION OF THE COOPERATIVE GROUP PROGRAM

The Cancer Therapy Evaluation Program (CTEP), which is part of the Division of Cancer Treatment and Diagnosis (DCTD) of NCI, administers the Cooperative Group Program, which represents a major component of DCTD’s extramural research activities. The NCI Cooperative Groups were originally organized by geographic area or, in some cases, by type of disease or therapeutic modality. Each Cooperative Group includes a large network of physicians, statisticians, nurses, clinical research associates, pharmacists, patient advocates, and other affiliated investigators. The Groups operate independently and have their own administrative structures, operating procedures, and committees. Each Group has an operations office and statistical center overseen by the Group chair and Group statistician, respectively. To be involved with a Cooperative Group, institutions must apply for membership and meet that Group’s eligibility criteria, including accrual potential and the ability to comply with Group standards and federal requirements. Each institution participating in a Cooperative Group is represented by a principal investigator, who manages the institution’s activities within the Group (Mauer et al., 2007).

Institutions participate in the Cooperative Groups as main member institutions, affiliates of a main member institution, or members of participating Community Clinical Oncology Programs (CCOPs). The main member institutions are generally academic medical centers or other major medical centers that are centrally involved in Cooperative Group activities. Main member institutions enroll a significant number of patients in clinical trials and also contribute scientific expertise and other resources to Group activities. Affiliate members, designated by the main member institutions, include community-based organizations and physicians’ practices and have lower patient accrual rates.

Created in 1983, “the CCOP network allows patients and physicians to participate in state-of-the-art clinical trials for cancer prevention and treatment while in their local communities,” according to NCI (2009b). The CCOP network can include hospitals, clinics, health maintenance organizations, groups of practicing physicians, or a consortium that agrees to work with a principal investigator through a single administrative unit (Mauer et al., 2007). Each CCOP chooses to join one or more CCOP Research Bases, which are NCI-designated Cancer Centers or Cooperative Groups that design, develop, and conduct clinical trials (NCI, 2009b).

OVERSIGHT OF CLINICAL TRIALS

Cancer clinical trials are highly regulated activities. Multiple agencies of the U.S. Department of Health and Human Services (HHS) review and



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