recommendations as to how to improve the current system. In April 2010, the consensus committee’s report, entitled A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program (IOM, 2010) was released to the public.1 The report’s recommendations are summarized in Box 1.

The authoring committee of the report concluded (IOM, 2010):

Collectively, the implementation of [the committee’s] recommendations would reinvigorate the Clinical Trials Cooperative Group Program for the 21st century and strengthen its position as a critical component of the translational pathway from scientific discovery to improved treatment outcomes for patients with cancer. Modifying any particular element of the Program or the clinical trials process will not suffice; changes across the board are urgently needed. All participants and stakeholders, including physicians, patients, and health care insurers, as well as NCI, other federal agencies, academia, foundations, and industry, must reevaluate their current roles and responsibilities in cancer clinical trials and work together to develop a more effective and efficient multidisciplinary trials system.

To discuss how best to achieve the aims underlying the recommendations in the IOM consensus report and to summarize progress to date toward addressing these recommendations, the IOM’s National Cancer Policy Forum and the American Society of Clinical Oncology (ASCO) convened a workshop on March 21, 2011, in Washington, DC. The goals of the workshops were to

1. Establish a venue to promote a collaborative approach by all stakeholders to implement recommended changes;

2. Provide a forum to ensure public involvement;

3. Document changes that take place; and

4. Facilitate progress toward the IOM committee’s goal of ensuring the continued viability and increased productivity of an NCI-funded clinical trials system with widespread academic involvement and community outreach.

This workshop included four panel discussions, which focused on (1) the roles of NCI and the Cooperative Groups; (2) the role of payors; (3) interactions between industry, the Food and Drug Administration, and the publicly funded cancer clinical trials system; and (4) the role of clinical

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1 The Executive Summary from the Institute of Medicine consensus report appears in Appendix B of this workshop summary.



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