the NCI Cooperative Group Program (IOM, 2010b). Recognizing the recent transformative advances in cancer research that necessitate modernization in how cancer clinical trials are run, as well as inefficiencies and other challenges impeding the national cancer clinical trials program, the NCI asked the IOM to develop a set of recommendations (summarized in Appendix B) to improve the federally funded cancer clinical trials system. These recommendations were published in the 2010 report. In early 2011, the NCPF and the American Society of Clinical Oncology (ASCO) held a workshop in which stakeholders discussed the changes they planned to implement in response to the IOM goals and recommendations (IOM, 2011).

Two years later, on February 11-12, 2013, in Washington, DC, the NCPF and ASCO reconvened stakeholders to report on the changes they have made thus far to address the IOM recommendations.1 At this workshop, representatives from the NCI, the NCTN, comprehensive cancer centers, patient advocacy groups, the Food and Drug Administration (FDA), industry, and other stakeholders highlighted the progress that has been made in achieving the goals for a reinvigorated national cancer clinical trials system, and discussed additional strategies to further improve the system.

This report is a summary of that workshop. An overview of key accomplishments since 2010 is shown in Box 1, and a summary of suggestions from individual participants for further improvements is provided in Box 2. A summary of NCI progress to date toward implementation of the IOM recommendations was presented by James Doroshow, director of the Division of Cancer Treatment and Diagnosis at the NCI, as shown in Table 1. The workshop agenda and statement of task can be found in Appendix A. The speakers’ biographies and presentations (as PDF and audio files) have been archived at


1 This workshop was organized by an independent planning committee whose role was limited to the identification of topics and speakers. This workshop summary was prepared by the rapporteurs as a factual summary of the presentations and discussions that took place at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants, are not necessarily endorsed or verified by the Institute of Medicine, the National Cancer Policy Forum, or the American Society of Clinical Oncology, and should not be construed as reflecting any group consensus.

The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement