139th National Cancer Advisory Board
harmonized. In addition to disclosure for highest level officers and staff members, the policy has specific provisions about ownership and financial interactions, and it applies to guidelines and to the ASCO Journal of Clinical Oncology (JCO). Dr. Hortobagyi stated that ASCO believes that the prospect for translational research advances in coming years requires a revisiting and restructuring of clinical trials and the development of creative endpoints to expedite and streamline the process of drug discovery. To that end, ASCO is working with the FDA and other professional societies to organize workshops for the consideration of optimal endpoint selection for the approval of cancer drugs. Results of the workshops are periodically presented to the Oncology Drug Advisory Committee, FDA, and other relevant organizations to enhance the process of drug development.
Dr. Hortobagyi noted that ASCO for several years has supported the concept of central review of clinical trials, particularly for multicenter or cooperative group trials. The ASCO Cancer Research Committee has discussed what the barriers for full utilization of the central IRB are and how they could be overcome and believes this is an area where ASCO could interact effectively with the NCI to identify barriers and work through the process of eliminating them. To address the low level of participation in clinical trials in comparison with some European countries, ASCO has developed a Clinical Trials Participation Award to reward community practices that make effective contributions to clinical trials. A final initiative in the area of clinical trials as a research priority is ASCO’s involvement in the issue of Medicare coverage of routine patient care costs. At the request of CMS, the issue has been considered by ASCO and recommendations have been sent for consideration by CMS in its review of the 2000 national coverage decision for clinical trials for Medicare participants. In addition, ASCO’s government policy component has communicated a number of other thoughts to the CMS.
Dr. Hortobagyi reported that ASCO supports a number of grant awards through the ASCO Foundation. These include the Advanced Clinical Research Award (ACRA), Young Investigator Award (YIAs) for last-year fellows and first-year junior faculty, and the Career Development Award (CDAs) for individuals in their second, third, and fourth years of faculty positions at an academic institution. Acting out of concern that young investigators be competitive in writing applications, ASCO has expanded a previous initiative and will hold a 5-hour course on writing effective grant applications at the next annual meeting. Plans are to invite CDA and YIA awardees to present the results of their grant-supported research for the benefit of future applicants.
Dr. Hortobagyi noted that, in gratitude for the work of the NCI and the cancer research enterprise during the past 40 years, ASCO membership intends to highlight their accomplishments over the coming year to raise awareness within the public, the group of political representatives, and other medicine specialties. For this purpose, the ASCO Clinical Cancer Advances Report was published in 2005 as a review of the most significant clinical research presented or published across the area of cancer. ASCO has used the Report to inform Congress and other organizations and is working on strategies to highlight the report and spread the information throughout the medical and scientific communities at large. Dr. Hortobagyi stated that ASCO believes continued funding for the NIH and NCI is critical and has supported the process by contacting members of Congress and continuing to interact with advocacy and other professional organizations. In another area of legislative advocacy, ASCO concern about the NIH reauthorization legislation has led to contact with Chairman Joe Barton (R-TX) and House Energy and Commerce Committee staff regarding the first two drafts. This legislative advocacy will continue in the hope that NCI’s authorities and responsibilities will be preserved in the reauthorization process.
Dr. Hortobagyi noted that quality of cancer care and quality of cancer research are important ASCO priorities and that a number of initiatives have driven this area of interest. The National Initiative on Cancer Care Quality (NICCQ) was based on the 1999 report of the National Cancer Policy Board entitled “Ensuring Quality Care.” The NICCQ initiative was the retrospective cohort study of incident