Philadelphia, PA: Robert L.
Comis, MD, President and Chair of the Coalition of National Cancer Cooperative
Groups, Group Chair of the Eastern Cooperative Oncology Group (ECOG), and
Professor of Medicine, Drexel University College of Medicine, testified
recently before the House Government Reform Committee to Examine Cancer
Clinical Trial Participation Rates. Dr. Comis was one of several cancer experts
to testify. The purpose of the hearing was "to examine the status of efforts to
bring innovative cancer treatments to the public and to discuss how to change
the face of cancer into a more chronic and treatable disease." The hearing
considered low participation of adults in cancer clinical trials and reviewed
the efforts to increase participation levels. Read the entire testimony
here.
Only 50,000 people - three to five percent of
eligible adult cancer patients - participate in cancer clinical trials each
year. Half of those (25,000) are treated by the physicians who comprise the
cooperative groups. (Cooperative groups are NCIsponsored networks of
researchers and physicians who conduct cancer clinical trials.)
In his testimony, Dr. Comis discussed various
pressures on the cancer research system including low accrual, lack of
awareness on the part of patients that treatment on a clinical trial is an
option, public misconceptions about how clinical research is performed, quality
of care while on a clinical trial, the regulatory burden on researchers, and
funding. “The cooperative groups have been, and remain, chronically under
funded at 60 percent of the recommended level. And this funding has been flat
for the last three years," Comis said. "This stifles innovation, destabilizes
key functions such as our tissue banks, data management and informatics
platforms and acts as a disincentive to both academic and community physician
participation."
Increasing regulations are another barrier to
increasing the number of patients on cancer clinical trials. Dr. Comis said,
"It is estimated that about 30 percent of the clinical trials research dollar
now goes toward ensuring regulatory compliance. Our studies are overseen by
about 1600 Institutional Review Boards (IRBs); HIPAA compliance also
complicates scientific work." He continued, "Current discussions about
off-label drug use in oncology could have a huge impact on our studies which
try to explore new indications and uses for targeted agents as they become
available. The ability for both academic and community sites to continue to do
government-sponsored work will be increasingly challenged, particularly when
the full effect of the Medicare Modernization Act of 2003 takes place in 2005."
Cooperative Group Recommendations for
Improving the System The Cooperative Group Chairs and the
Coalition’s Patient Advisory Board, under the aegis of the Coalition, have
developed a set of proposals to restructure and improve the clinical trial
process in a document called, "Harnessing the Science – Advancing Care: A
Proposal to Improve the Publicly-Funded Cancer Clinical Research System." This
document was presented as part of Dr. Comis’ testimony. "The overall goal of
our recommendations is to reduce the time it takes to activate new trials and
increase the number of completed, high-quality trials," said Dr. Comis. "With
the support of the NCI, we are confident that these recommendations will give
the system renewed vigor to achieve its mission of reducing the burden of
cancer."
"Harnessing the Science – Advancing Care" contains 25
recommendations which address streamlining the system, establishing scientific
priorities, accelerating protocol development and improving funding.
About the Coalition
The mission of the Coalition of National Cancer Cooperative Groups is to
improve the quality of life and survival of cancer patients by increasing
participation in cancer clinical trials. The Coalition’s programs and services
are constructed to achieve this mission through the execution of the following
strategic imperatives: providing leadership, increasing awareness, involving
doctors, and improving the clinical trial system for our nationwide network of
8,000 medical, surgical, and radiation oncologists, and researchers. Thirty-six
patient advocacy organizations are associate members of the Coalition. For
additional information on clinical trials, visit
www.CancerTrialsHelp.org .