CHICAGOThe new Childrens Oncology Group, which will
include and replace four major pediatric cancer research groups, is
expected to be up and running soon after the end of the year. The new
cooperative group will include most researchers working on pediatric
cancers and will initially comprise those currently associated with
the Pediatric Oncology Group (POG), Childrens Cancer Group
(CCG), National Wilms Tumor Study Group, and Intergroup
Rhabdomyosarcoma Study Group.
Vita J. Land, MD, executive officer of POG, told ONI in an interview
that the merger was a response to both internal and external pressures.
The urge to merge is partly the price of our success, Dr.
Land said. The pediatric cancer cooperative trial groups have been
widely admired for their ability to achieve full accrual and complete
clinical trials in a timely manner. The cure rates in some pediatric
cancers are now so high that quite large numbers of patients will be
required for studies to show additional improvement with new
therapies. These include acute lymphocytic leukemia, with a cure rate
of 70% to 75%, and Wilms tumor, with a cure rate of 90%.
This problem has been addressed through international, intergroup
studies, but Dr. Land said that a simpler collaborative process is
needed, and merging the clinical trials groups would help achieve
The external pressure is pediatric researchers awareness of
growing demands from Congress and various oversight bodies for
greater efficiency in how clinical trials are conducted. A major
recommendation has been that cooperative groups combine their
We realized that we should initiate this merger ourselves,
based on good science, rather than waiting for others to recommend
it, Dr. Land said. We had a window of opportunity to be
proactive, and we had very strong collaboration with and support from
the National Cancer Institute in doing so. We are designing our own
systems and Clinical Trials Support Unit with the help of additional
federal funding and industry support.
To help smooth the transition, for example, the NCI adjusted
deadlines on a number of expiring grants and extended some so that it
will be easier for the merged groups to handle the grant application
Savings in Time and Energy
Dr. Land expects the merger to achieve considerable savings in the
time and energy that has been needed to run intergroup studies.
Savings can be achieved by simplifying administrative procedures and
the levels of approval needed. Also, the merger will eliminate the
need to coordinate two or more operations offices, including
monitoring patient registration at two operations offices and
obtaining multiple institutional review board approvals.
Our mandate is to ensure that all children with cancer in
Canada and the United States have access to the best treatment,
either from or supervised by a member institution of the CCG or
POG, Dr. Land said. We are currently deliberating on
criteria for membership in the Childrens Oncology Group. We
expect that in early 2000, all current POG and CCG institutions and
researchers will be grandfathered in. Then, over the following 3
years, all 230 institutions will have to undergo the same review as
new applicant institutions.
Among the criteria expected to be adopted by the Childrens
Oncology Group to maintain membership are that a research team must
see at least 12 new pediatric cancer cases per year and must register
at least 50% of eligible patients on approved clinical trials, or a
minimum of 35 patients, whichever is less.
Integrating the information systems of the four groups has been a
major challenge. That task includes preserving and maintaining access
to the extremely valuable information in each groups existing
database. Dr. Land said that this work is being overseen by a
transition committee that includes the chairs of all four groups.
Since the new group will include most of the pediatric oncology
researchers in the United States and Canada, questions have arisen
about who will be left to review grant proposals from Childrens
Oncology Group researchers.
Dr. Land believes that peer review will not be a problem because
grant proposals are already subjected to extensive internal peer
review within all four current groups, and this process is expected
to continue in the new cooperative group.