Philadelphia, PA and Washington, DC (PRWEB) May 20, 2011
The Coalition of Cancer Cooperative Groups today released a set of guiding principles for the successful overhaul of the National Cancer Institute (NCI) sponsored Clinical Trials Cooperative Group Program. Prepared by the cooperative group chairs (the Coalition Board), the principles are aimed at ensuring that upcoming changes to the federal funding guidelines under which they operate lead to a strengthening of group-generated science that improves the outcomes for patients with cancer.
The Clinical Trials Cooperative Group Program is the main publicly funded vehicle for the design and conduct of Phase III and large Phase II cancer clinical trials in the United States, and, is therefore crucial to defining the standards of care for cancer patients.
Until July 2011, the NCI and National Institutes of Health are eliciting public comment regarding the upcoming changes to the Funding Opportunity Announcement (FOA) by which the cooperative groups apply for multi-year grant awards from the NCI.
“Optimally, the new federal grant guidelines will strengthen our scientific programs, and optimize patient and physician access to publicly funded cancer clinical trials of the utmost scientific integrity and innovation,” said Robert L. Comis, M.D., president and chairman of the Coalition. “We believe that the principles we’ve outlined will provide greater clarity for stakeholders during these final days of the public comment period.”
The first principle from the group chairs is that the best interests of patients are served by having strong scientific programs. Together the set of eight principles discuss: the groups as an integrated hub for large Phase II, and Phase III studies; the need for flexibility in the funding guidelines to allow groups to be diverse in their make-up so as to retain their areas of scientific expertise; preservation of the groups’ strong membership culture; ways in which the study review process should incentivize scientific innovation; the viability of the cooperative groups relative to their critical resource requirements; and the multi-sector involvement that supports and supplements NCI-approved clinical studies. The principles conclude with a definition of certain Essential Characteristics that applicants for cooperative group funding should possess in order to produce excellence in science and ensure groups remain focused on improving the outcomes for patients with cancer. The full set of guidelines is available at the Coalition’s web site http://www.CancerTrialsHelp.org.
The group chairs previously gave their endorsement to a set of recommendations made by the Institute of Medicine (IOM) in April 2010, that the Cooperative Groups be restructured to optimize scientific innovation, improve efficiency, provide adequate financial support to clinical trials, and incentivize physician and patient participation in clinical trials.
Relative to public funding, the NCI announced last November that it will support up to five cooperative groups under the new guidelines: the Children’s Oncology Group, which studies cancers in children, as it stands, and up to four cooperative groups addressing cancers among adult patients. Some cooperative groups are now in the midst of voluntary consolidation to strengthen their science and improve efficiencies (one of the IOM’s recommendations).
About the Coalition
The Coalition of Cancer Cooperative Groups is an independent non-profit 501(c)3 service organization working to improve physician and patient access to cancer clinical trials through education, outreach, advocacy and research. The Coalition promotes the pivotal role of cancer clinical trials in the discovery of prevention and treatment advancements, and advocates to ensure adequate funding for a robust public cancer clinical trials system towards that goal.