The Clinical Trials Review Group was asked to recommend changes to the current system that would (1) take advantage of the most promising opportunities in therapy and diagnosis; (2) prioritize the most important research questions so that they can be explored in the fastest possible time; (3) improve the organization, funding, review, and cooperation in the Cooperative Group Program; and (4) attract both patients and researchers to participate in clinical trials.

The review committee met six times over an 11-month period and included experts from academic research institutions, cancer centers, community oncology practices, cancer patient advocacy groups, and the National Institutes of Health. The committee released its findings, known as the Armitage report, after its chair, James Armitage, in 1997 (NCI, 1997). The report made the recommendations regarding review, funding, design, oversight, and administration of the NCI clinical trials system. A subsequent implementation committee report was completed in 1998.

Clinical Trials Working Group Report

In 2004, the NCI director established the CTWG to advise the National Cancer Advisory Board on the development, conduct, infrastructure, support, and coordination of cancer clinical trials across NCI. The CTWG was asked to develop recommendations to (1) optimize the NCI-supported clinical trials system by improving coordination and research infrastructure, (2) remove institutional and regulatory barriers that inhibit collaboration in clinical trials research, and (3) envision how clinical trials should use the tools of contemporary bioinformatics and molecular medicine.

The review committee conducted 7 face-to-face meetings and 10 group conference calls over a 16-month period and included experts from academic research institutions, community oncology practices, the pharmaceutical and biotechnology industries, cancer patient advocacy groups, NCI, the Food and Drug Administration (FDA), and the Centers for Medicare & Medicaid Services (CMS). The committee released its findings in 2005 (NCI, 2005b).

The committee proposed 22 recommendations to achieve four major goals for designing a more efficient national system for clinical trials conducted or supported by NCI, as follows: (1) better coordination, (2) prioritization based on solid science and the needs of patients, (3) standardized tools and procedures, and (4) improved operational efficiency (NCI, 2005b).

Recommendations

While the Armitage report had a broader focus than the CTWG report, including a focus on issues such as organization, prioritization,



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