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139th National Cancer Advisory Board

Dr. Hortobagyi then summarized the areas where there is potential for ASCO and NCI collaborations. These include: (1) enhancing the visibility of federally funded cancer research and advocating for continued support; (2) working to ensure that conflict-of-interest policies are effective yet fair and equitable; (3) promoting the central review of clinical trials and working to understand and remove obstacles if possible; (4) understanding the consequences of HIPAA and ensuring that the research process is efficient and devoid of obstacles and yet protects the individual’s right to confidentiality; and (5) working toward expanded Medicare coverage of clinical trials. In terms of the future, Dr. Hortobagyi expressed the view that cancer research is beginning to harvest the tangible results of 40 years of intensive research and that the momentum must be maintained. He stated, therefore, that collaborations in research, access to care and high-quality research, and training for the next generation of investigators are paramount and will be a critical focus of ASCO future effort.

Questions and Answers

Dr. Coffey asked for specific issues included in the informative review of ASCO activities to which the Board can contribute. Dr. Hortobagyi replied that the intent of his presentation was to provide information to NCAB members who are not aware of the extent of ASCO activities, but he identified access to high-quality clinical trials and high-quality care as areas where ASCO and the NCI can work together. Another area for emphasis would be interaction among the NCI, FDA, and ASCO on translational research to make drug development and the clinical trials process more effective. Dr. Runowicz agreed that areas where collaboration is critical to success in solving the cancer problem are improving discovery, prevention, access to care, and training for the next generation of researchers. Dr. Hortobagyi observed that several hundred new drugs are being discovered throughout industry and that the NCI systems and the current rate of accrual to clinical trials will preclude developing those drugs effectively. He cited insurance reimbursement and issues related to various regulatory activities as two of a number of obstacles to clinical trials accrual that must be worked through collaboratively and eliminated.

From the patient perspective, Ms. Giusti expressed the view that synergies are needed between community centers, which are gateways to care for many people, and the academic centers, where many of the trials are initiated, to create feeder systems that would be beneficial in both clinical trial accrual and tissue acquisition. Dr. Chabner recommended central review for clinical trials as an area where ASCO and the NCI should collaborate and reach consensus on the kind of review necessary for clinical protocols. He cited the conflicting messages that Cancer Centers receive, and he observed that trials could be activated earlier and questions answered more quickly for FDA review purposes. Dr. Doroshow cited the issue of so many trials and so few patients as one to be addressed, and he noted that work is proceeding on a prioritization process for all NCI-supported trials. The process brings together all stakeholders to focus available resources and enhance the system. He expressed the view that the rate of accrual is the issue rather than total accrual so that trials can be finished earlier and the next question addressed. Dr. T.J. Patel, Program Director, Oncology and Kidney Diseases, Veterans Health Administration (VHA), discussed the recent charge received at the VHA to write a policy on colorectal cancer screening, with timelines for moving through the various tests to biopsy then to surgery or radiation or chemotherapy. A search for a model ended at the National Health Service in the United Kingdom. He expressed the view that guidelines and timelines for cancer would enhance the quality of cancer care and that the NCI should take the lead in creating different timelines and sets of standards and performance measures.


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