NCI Announces Plans to Reinvigorate Clinical Trials
Posted Dec 23 2010 3:44pm
The National Cancer Institute (NCI) has announced major changes to be
made in the long-established Clinical Trials Cooperative Group Program
that conducts many of the nationwide trials of new cancer therapies.
In a major transformation, NCI intends to consolidate the nine groups
that currently conduct trials in adult cancer patients into four state-of-the-art
entities that will design and perform improved trials of cancer therapies.
These changes are designed to provide greater benefits for cancer patients
and more information for researchers. These moves come in response to
an NCI-requested April 2010 report from the Institute of Medicine (IOM),
which called for a series of changes to the cooperative groups program,
"Clinical trials are at the heart of cancer care and treatment,
and NCI is dedicated to making sure they are as effective as they can
be," said Harold E. Varmus, M.D., NCI director. "In the last
decade, our knowledge of genetic and epigenetic changes that drive the
initiation and progression of cancers has increased exponentially. Consequently
we must assess and improve the methods by which NCI evaluates new therapies
that take advantage of our new understanding of many kinds of cancers."
The April IOM report noted that the current trials system is inefficient,
cumbersome, underfunded, and overly complex. The report recommended consolidating
existing adult cooperative groups into a smaller number of groups that
could function in a more closely integrated manner.
The NCI Cooperative Group program, founded over 50 years ago, involves
more than 3,100 institutions and 14,000 investigators, and the program
enrolls over 25,000 patients in clinical trials each year. Four pediatric
groups were consolidated into one group a number of years ago, and that
sole pediatric group will not be consolidated with other groups.
"The practice of oncology has changed significantly with the development
of molecular oncology, therefore we need a modern system with modern
trials that will maximally utilize the molecular characteristics of a
patient's tumor and guide us to the best possible treatment for that
patient," said James H. Doroshow, M.D., director, NCI Division of
Cancer Treatment and Diagnosis. "This evolution in our understanding
of cancer will lead to an evolution in the design and implementation
of clinical trials.
For the past several decades, clinical cancer trials have used one or
a combination of drugs or other treatment modalities, such as surgery
or radiation, in comparison to the prevailing standard of care to see
if the new treatment was superior. Recently, some trials have begun to
depend on the genetic profiling of tumors. For example, one ongoing NCI-sponsored
breast cancer study, called TAILORx, is examining whether genes that
are frequently associated with risk of recurrence for women with early-stage
breast cancer can be used to assign patients to more appropriate and
These types of studies necessitate the screening of large numbers of
patients in order to find subsets of patients with tumors that demonstrate
changes in specific genetic pathways. These trials therefore require
acquisition and distribution of many tumor specimens, DNA sequencing,
and the matching of genetic information with treatment options. The increased
complexity of these trials provides a rationale for modernization and
simplification of the current cooperative group structure.
Consolidation is intended to improve the efficiencies of operations
centers, data management centers, and tumor banks, and the changes will
take into consideration an assessment of all currently active cooperative
groups. The current groups will also be given opportunities to comment
on the proposed changes and to explore specific aspects of the reorganization
plans in consultation with NCI leadership.
While consolidation of specific groups proceeds, other generalized efficiencies
are already being planned, such as shortening the time required to initiate
new clinical trials. Historically, when a new study was proposed, the
concept had to be submitted for approval in a process that took as long
as several years. Furthermore, if this review was not completed within
two years after concept approval, a trial was very unlikely to reach
its ultimate recruitment goals, in part because the scientific questions
underpinning the concept could be overtaken by new developments.
On Jan. 1, 2011, NCI will impose new deadlines, formulated by its Operational
Efficiency Working Group, which will reduce by half the time to initiate
new clinical studies and will terminate studies not begun within two
years of concept approval.
NCI has also been working to increase efficiency in several other ways,
Decreasing the average time for final sign-off and approval on protocols
for national trials by its centralized institutional review board from
150 days in 2007, to 42 days in 2010
Prioritizing a revamped review process, which will include advocates
and professionals at cancer centers, with new emphasis on disease-specific
and modality-specific oversight, such as imaging or cancer control
Modernizing information technology so that a single system can collect
standardized clinical trial data, such as patient information and outcomes
A list of the current 10 U.S.-based NCI Cooperative Groups can be found
at http://www.cancer.gov/cancertopics/factsheet/NCI/clinical-trials-cooperative-group NCI,
a component of the National Institutes of Health (NIH), leads the National
Cancer Program and the NIH effort to reduce the burden of cancer and improve
the lives of cancer patients and their families, through research into
prevention and cancer biology, the development of new interventions, and
the training and mentoring of new researchers. For more information about
cancer, please visit the NCI Web site at http://www.cancer.gov or
call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).
The National Institutes of Health (NIH) — The Nation's Medical
Research Agency — includes 27 Institutes and Centers and is
a component of the U.S. Department of Health and Human Services. It is
the primary federal agency for conducting and supporting basic, clinical
and translational medical research, and it investigates the causes, treatments,
and cures for both common and rare diseases. For more information about
NIH and its programs, visit www.nih.gov .