National Cancer Institute - NCI Division of Cancer Treatment and ...

of pediatric cancers and therapeutic
agents is needed. In 2005, plans were
made to test 12 new agents against
a molecularly characterized panel of
childhood cancers each year.
Office of AIDS Malignancy Program
http://ctep.cancer.gov/resources/
aidsmalignancy
The Office of AIDS Malignancy Program
is designed to support extramural HIV
and AIDS malignancy research. The office
coordinates all AIDS and AIDS oncology
efforts across NCI, including the development
of extramural initiatives and AIDS
co-funding agreements. Projects being
managed include the AIDS and Cancer
Specimen Resource, the Women’s Interagency
HIV Study, the Multicenter AIDS
cohort study, and the AIDS International
Training and Research Program. The office
works closely with the Centers for AIDS
Research (CFAR) at NIH, providing administrative
and research support for AIDS
research projects.
The programs emphasize the importance
of collaboration between disciplines and
between basic and clinical investigators,
of research in which laboratory discoveries
are translated into clinical practice, and
of research on prevention and behavioral
change.
Improving the Clinical Trials System
In addition to implementing recommendations
of the Clinical Trials Working
Group (http://integratedtrials.nci.nih.gov/),
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CTEP is making other changes to accelerate
the development of new interventions.
CTEP has established the following
priorities:
■ Accelerating therapeutics development
by:
• Speeding the concept approval
process by meeting with cooperative
group phase III investigators, as well
as partners within the Food and
Drug Administration (FDA) and
industry, to resolve clinical trial issues
in a rapidly scheduled joint meeting
and discussion process rather than
in a time-consuming iterative review
process
• Decreasing the time from concept
approval to protocol implementation
by developing joint Protocol Development
Teams with the cooperative
groups
■ Increasing the transparency and expertise
of the CTEP review process by
engaging external scientists and
advocates in the review of all concepts
for phase III trials
■ Expanding access to clinical trials
through continued growth of the
Cancer Trials Support Unit (www.ctsu.org)
■ Continuing improvement of the informatics
infrastructure that supports
clinical trials by continuing development
of clinical trials standards, including
the common toxicity criteria and
common data elements, and by the
development and pilot implementation
of a remote data capture system for the
collection of clinical trial data