BETHESDA, MdThe National Cancer Institute plans a major
restructuring of its clinical trials program, intended to broaden
participation by physicians and patients and shorten the time between
the initial idea for a treatment study and its conclusion.
The plan calls for a new review method to assess proposals for large
clinical trials, an open menu of large studies to
increase patient access and accrual, and the consolidation and
streamlining of many administrative functions. It ultimately
envisions a national network of investigators and physicians to carry
out NCI-sponsored clinical research that can function without
artificial boundaries, enrolling patients in high-quality trials
wherever they may be and regardless of coordinating site.
Two anticipated results of this restructuring will be more
competitive research proposals and a diminished role for the
nations 12 cancer clinical trials cooperative groups.
The changes are outlined in a report from NCIs Clinical Trials
Implementation Committee, co-chaired by John H. Glick, MD, of the
University of Pennsylvania Cancer Center, and Michaele C. Christian,
MD, from NCIs Division of Cancer Treatment and Diagnosis.
NCI will phase in the restructuring, beginning with pilot programs in
the areas of genitourinary cancers and lung cancer. Its
very complicated, NCI director Richard D. Klausner, MD, told
the National Cancer Advisory Board. I keep saying, this is not
going to happen overnight.
The committee, whose 27 members were selected from within and outside
the Institute, included representatives from the cooperative groups,
cancer centers, professional societies, and patient advocacy organizations.
The committee identified a number of objectives for the clinical
trials program, Dr. Christian told NCAB members. These include
ensuring that the best science is incorporated into large clinical
trials, increasing the speed of implementing studies, substantially
increasing accrual, decreasing complexity, and providing fair
compensation to cover the costs of trials. This framework led to a
number of key committee recommendations related to large phase III
State-of-the-Science Meetings: These regularly scheduled
national forums will seek to identify research opportunities and gaps
in research in specific disease areas. This process is currently done
within NCI, with outside participation largely confined to
investigators from the relevant cooperative research groups.
Participants in the new system will be broadly representative of the
cancer research effort and will include basic and clinical
scientists, industry representatives, patients, and advocacy groups.
Results from the discussions will be circulated widely within the
research community and made readily available to clinical
investigators and the public.
Idea Generators: This bureaucratic designation simply means
investigators who propose phase III trials. The point of the new
system is to cast as broad a net as possible for these individuals,
instead of relying primarily on researchers working in the clinical
trials cooperative groups. While these groups will remain an
important source of ideas, NCI envisions a greatly increased number
of phase III trial proposals coming from cancer centers, community
oncology practices, and the pharmaceutical industry.
The idea of broadening this pool is obviously designed to
stimulate development and competition of the best ideas, Dr.
Christian said. Concepts for phase III trials will be accepted
from all interested investigators, irrespective of affiliation.
NCI staff will work to put investigators who dont have access
to the resources necessary to carry out the analysis of large trials
together with funded statistical centers in order to facilitate
the conduct of these clinical trials, she added.
Concept Review Committees: These broad-based, disease-specific
groups will review every proposal to NCI for a phase III trial,
replacing the current system of review within NCI. Committee members
will include clinical and basic scientists, statisticians, and
patient advocates, with one-third of the members coming from NCI,
another one-third from cancer centers, and the rest from a variety of sources.
Once a clinical trial proposal wins approval, the study team will
receive funds to speed up protocol development and administration,
and the team, led by the idea generator, will conduct the study,
analyze the data, and publish the study results.
Cancer Trials Support Units: These groups will perform two key
functions. First, they will consolidate duplicative administrative
functions, including protocol registrations, data transfer from
investigators to statistical centers, and some education and training
activities. Second, they will serve as a single source for physicians
who wish to enroll patients in trials across this cooperative
system, rather than interacting with one or two or four additional
cooperative groups, Dr. Christian said.
National Network: Once a concept is approved, it will be
developed into a protocol that will be open to a national Network of
physicians, including members and nonmembers of cooperative groups.
All qualified participants in the Network will have access to all
trials of the Network. (The Network will be piloted by cooperative
group members initially, with non-group-members phased in over time.)
New Informatics: A common infor-matics system will link
investigators with the Cancer Trials Support Units, facilitating all
aspects of protocol generation and trial conduct. The system will
include common forms, uniform interfaces with trial participants,
common data elements, and electronic interfaces between data centers
and sponsors for easy reporting.