2012 EDUCATIONAL BOOK - American Society of Clinical Oncology

The New National Cancer Institute National
Clinical Trials Network
Overview: The National Cancer Institute (NCI) Cooperative
Group Program has been reviewed by three published studies
in the last 7 years evaluating the efficiency and effectiveness
of this national oncology clinical trials system. The recommendations
for improvement from these reports have
prompted NCI to transform the Cooperative Group Program
THE NCI Cooperative Group Program has been an
essential contributor to the discovery of new cancer
therapies over the last 50 years. The program comprises
networks of cancer centers and community oncology practices
that develop and conduct large-scale multicenter
clinical trials and promote discovery of correlative cancer
science. The cooperative groups have established the therapies
now routinely used to diagnose, prevent, and treat
cancers.
In 2007, the NCI director requested the Institute of
Medicine (IOM) conduct a consensus study of clinical trials
and the NCI Cooperative Group Program and provide recommendations
to improve the system. This evaluation was
preceded by an NCI review of the system by the Clinical
Trials Working Group (CTWG) in June 2005. The IOM
convened a 17-member committee representing a broad
range of the oncology research community. The activity
was supported by funding from the NCI and other cancer
research organizations, including ASCO. A report was
issued in April 2010 titled, “A National Cancer Clinical
Trials System for the 21 st Century.” Key features of the
report are listed in Table 1.
The NCI has responded to the IOM, CTWG, and the
March 2010 NCI Operational Efficiency Work Group
(OEWG) reports with a proposed transformation and reorganization
of the cooperative groups into a new NCI Clinical
Trials Network (NCTN). Network goals are listed in Table 2.
To achieve these goals, the NCI has embarked on cooperative
group consolidation and reconfiguration of the network
evaluation process and funding.
The NCI has recommended the 10 cooperative groups
consolidate to four adult-oriented groups and one pediatric
group. The existing nine adult-oriented groups have elected
to merge or affiliate into the four entities listed in Table 3.
The NCI is in the process of developing a new funding
opportunity announcement (FOA) to be published in July
2012 that will establish the new evaluation and funding of
the network. The NCI has articulated the goals of the new
system evaluation (Table 4). NCI oversight and prioritization
of the network will utilize the existing Disease Steering
Committees and a newly proposed Cross-Disease/Trials
Oversight Panel. More efficient clinical trials development
and activation have already been implemented by strict
timelines established in the OEWG report.
The new FOA is expected in July 2012, and competing
applications for the new FOA are to be submitted by November
2012, with NCI review in February 2013. Network
awards are expected in late 2013 with funding to begin in
2014.
146
By Stephen S. Grubbs, MD
into a new NCI National Clinical Trials Network (NCTN) to
improve the efficiency of large clinical trials and increase the
speed of cancer translational research. The new NCTN offers
community-based clinical investigators new opportunities to
advance cancer research in their community setting but also
presents challenges in promoting community-based research.
KEY POINTS
● The Institute of Medicine, the Clinical Trials Working
Group, and the Operational Efficiency Working
Group have published evaluations recommending improvements
of the National Cancer Institute (NCI)
Cooperative Group Program.
● The NCI is transforming the Cooperative Group Program
into a National Clinical Trials Network by
group consolidation and a new evaluation and funding
model.
● Nine adult disease–oriented cooperative groups have
responded by consolidating into four groups, joining
the existing single pediatric-oriented cooperative
group.
● Community clinical trial sites and investigators will
potentially gain access to a greater variety of trials,
will benefit from operational standardization between
groups, and may achieve increase per case
reimbursement.
● Community sites, however, will be challenged by
diminished volunteer investigator time and pressure
to produce high accrual volume and remain at risk for
per case funding below actual cost.
Community Needs from the NCI NCTN
Community clinical investigators are essential participants
in a successful national oncology clinical trials system.
They have access to large numbers of newly diagnosed
patients and contribute significant accruals to phase III and
cancer control and prevention trials. The Community Clinical
Oncology Program and cancer center community affiliate
sites contribute over 50% of the patients annually to
the cooperative group total accrual. The new NCTN offers
opportunities and challenges for the community clinical
investigators.
A successful community clinical trials site requires five
From the Helen F. Graham Cancer Center, Delaware Christiana Care CCOP Newark,
DE.
Author’s disclosure of potential conflicts of interest are found at the end of this article.
Address reprint requests to Stephen S. Grubbs, MD, Helen F. Graham Cancer Center,
Delaware Christiana Care CCOP, 4701 Ogletown-Stanton Rd., Newark, DE, 19713-2055;
email: ssgrubbs@cbg.org.
© 2012 by American Society of Clinical Oncology.
1092-9118/10/1-10