Director's Update: March 23, 2004
On March 17, the Clinical Trials Cooperative Group Chairs came to NCI to continue an ongoing dialogue about re-engineering the cancer clinical trials infrastructure to improve the publicly funded cancer clinical research system.
The cooperative groups have played an integral part in the many accomplishments of our cancer clinical trials infrastructure, but we all agree we must commit to a process of continuous improvement and must adapt to the challenge of the future of molecular oncology.
For almost a year, the Cooperative Group Chairs worked together under the aegis of the Coalition of National Cancer Cooperative Groups to develop recommendations to improve the nation's multicentered cancer clinical cooperative groups research system. Based on what the Chairs see as influencing the future of the system - unprecedented opportunities in cancer treatment and prevention; more complex clinical trials that incorporate molecular profiling, pharmacogenetics, and advanced imaging; regulatory challenges; and the existing clinical trial programs that could function more efficiently and effectively as an integrated, public system - they outlined three main categories for discussion:
- Reducing structural barriers. To remove structural barriers the Chairs proposed 1) harmonizing guidelines to allow trial participation regardless of institutional affiliation, 2) encouraging collaboration through modification of peer-review mechanisms, 3) providing opportunities for cancer centers and SPOREs to function as central laboratories for trials, 4) establishing an inventory of repositories and their capabilities, 5) developing an integrated informatics platform, and 6) rewarding leadership and finding incentives for collaboration.
- Adjusting NCI pilot programs and oversight role. To accelerate the pace of cancer clinical research, the Group Chairs recommended establishing expedited study review and activation processes, eliminating redundancy in the review system, and strengthening the NCI programs that facilitate trials across centers and groups.
- Encouraging public-private partnerships. The Group Chairs proposed increased support for public-private partnerships that encourage industry participation in clinical research by recognizing industry-sponsored trials in the peer-review process and by facilitating regulatory review of industry-sponsored trials.
NCI recently established a Clinical Trials Working Group as a subcommittee of the National Cancer Advisory Board. The subcommittee, led by Drs. James Doroshow and Howard Fine, will develop an architectural blueprint of a national clinical trials system led by NCI. The discussions between NCI leadership and the Group Chairs covered many overlapping topics that addressed the efficient management of the clinical research enterprise. After NCI leadership and the Clinical Trials Working Group have an opportunity to examine the issues raised at the March 17 meeting in the context of the overall NCI clinical research program, I will strategically focus on each of the specific issues and work with the cooperative groups to fully assess opportunities for streamlining infrastructure. I will meet with the representatives of the Group Chairs in three months to update progress.
I am grateful to the Chairs for the thought and effort they put into their recommendations. I am also committed to work with them and other groups, including the Community Clinical Oncology Program, cancer centers, SPOREs, and the Intramural Research Program, to promote broader coordination and redefine the nation's cancer clinical research program to serve the needs of oncology in 2015.
Andrew C. von Eschenbach, M.D.
Director, National Cancer Institute
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