PHILADELPHIA,
PA, D.C., May 19, 2011
via PRWeb – 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 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.
###