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

Cancer clinical research is
changing, and a large part of
the transformation is being
spearheaded by the Division of Cancer
Treatment and Diagnosis (DCTD),
an extramural component of the
National Cancer Institute (NCI) with
the responsibility of overseeing much of
NCI’s infrastructure for clinical trials and
drug development. I am pleased to provide
you with this summary of accomplishments
made possible by the many talented and
dedicated staff members in programs
throughout the division.
Advances in molecular medicine have
created new challenges for the design
and conduct of cancer clinical trials. The
National Cancer Advisory Board’s Clinical
Trials Working Group (CTWG) examined
these challenges and, last year, issued
22 strategic initiatives to restructure the
conduct of NCI-supported clinical trials so
that new treatments reach patients with
cancer more quickly. The CTWG endorsed
team science in the broadest sense. This
included the development of mechanisms
to enhance the coordination of clinical,
basic, and translational scientists in their
efforts to improve molecular diagnostic
and imaging techniques, as well as to
increase the utility of novel targeted therapies.
The success of the CTWG initiatives
will require a significant commitment by
all stakeholders in the clinical trials process
to assist NCI in setting new policies,
procedures, and standards and in guiding
prioritization and decision-making.
DCTD will play a leading role in the
implementation of the CTWG initiatives,
with the goal of producing an integrated,
F O R E W O R D
Dr. James H. Doroshow, Director, NCI Division
of Cancer Treatment and Diagnosis.
responsive, efficient, and innovative clinical
trials enterprise. The division will also
assist the newly created NCI Coordinating
Center for Clinical Trials as it assumes
the day-to-day responsibilities for project
management of the CTWG initiatives.
As part of the change process, DCTD
and the Center for Cancer Research
(CCR) are working in close collaboration
to reinvigorate cancer drug development
at NCI. Through a new, joint early therapeutics
development program, extramural
and intramural teams have prioritized a
pipeline of NCI-driven targeted therapeutics
for development. This program combines
the strengths of DCTD’s extensive
expertise in anticancer drug development
with CCR’s dynamic in-house research
and its location within new state-of-theart
facilities at the NIH Clinical Research
Center. This collaboration will also utilize
a recent guidance from the U.S. Food and
Drug Administration concerning exploratory
studies of investigational new drugs.
F O R E W O R D ■ iii