What makes a new research opportunity worthy of our investment? The NCI
continues to support superlative studies in all areas of basic, clinical,
and population-based cancer research. These studies continue to be highlighted
by spectacular advances in both our knowledge of how cancer occurs and in
better clinical care. However, in preparing this budget it became clear
that there were several areas where our efforts were not sufficient to exploit
a particular research development. Several of these areas provide the opportunity
to invest in the research future. To document the unique nature of these
extraordinary opportunities for new investments, we have presented them
as a special addition to this budget document. Included below are the plans
for these areas, including the goals of each of these projects and the milestones
to judge their success.
These areas for investment were discovered through a simple process. For
the last six months we have been gathering with scientists, educators, and
community leaders to discuss the state of our cancer research enterprise.
At each setting we have been probing the collective wisdom of the group
with many questions. One difficult question was, "Where are we failing?"
Hearteningly, we have found that our most serious failures are primarily
ones of omission; that is, where we are failing to pursue promising leads.
Some of these we can correct by simple redirections of our efforts, and
even now most of these are on their way to being remedied.
Some of the omissions were of a different flavor. Perhaps there was some
new technical advance that we weren't exploring fully or maybe our knowledge
had reached a stage where we could plan a new attack and, by doing so, catapult
our knowledge to a new level. Over the six months of these discussions,
60 different proposals for new opportunities came forth. As the subjects
of these 60 were explored, criticized, and refined, we realized that they
were often different views of the same issues. Sixty quickly coalesced to
five. The five programs that deserve immediate investment are:
* Cancer Genetics
* Preclinical Models of Cancer
* Detection Technologies
* Developmental Diagnostics
* Investigator-Initiated Research
These are the five areas where we believe new investments will pay the largest
dividends. They are, in many ways, new windows of discovery that have been
opened through past successes.
The Criteria for an Extraordinary
Opportunity for Investment
In proposing these initiatives, we decided that to be considered as an
extraordinary opportunity for investment, the initiatives had to meet several
criteria. The initiatives had to respond to an opportunity opened by a recent
change or development. The initiatives we propose are responses to recent
advances in our knowledge such as the rapid identification of new cancer
genes, to recent technological breakthroughs such as the ability to develop
preclinical models of cancer, or to looming social responsibilities such
as the issues raised by genetic testing. The initiatives had to provide
approaches that go beyond the size and scope of our current portfolio of
research activities but still be ones that could be capitalized on with
specific, defined investments. 
The
five areas we have identified can be enacted with a total of $269.5 million
of additional, new funds in FY 1998. The derivation of this budget is described
in each section below. The opportunities have been articulated in goals
with achievable milestones, which appear in each section. Finally, we have
described both the benefit of investing in these new opportunities as well
as the consequences of waiting or not investing. Again, this information
is included below in the discussions of each opportunity.
Clearly there is a vast number of opportunities for investment in cancer
research. We have touched on but a few of these in outlining what is supported
by the Estimated Budget for FY 1997 and the Maintenance Budget for FY 1998.
But we feel these five opportunities warrant substantial new investments--investments
that will expand the budget beyond its current level. We must not lose sight,
however, that investment is always underway. Each year a substantial portion
of our research portfolio produces discoveries that are the basis for new
investigations. Research today is supplanted by new projects tomorrow. For
example, our gains in improving current therapies and establishing the efficacy
of new therapies have been built on two decades of investments in the Clinical
Trials Cooperative Groups, the CCOP, Cancer Centers, and individual and
program project grants. We will continue to monitor discoveries across the
cancer program and evaluate with our advisors where new investments will
expand the research program in new dimensions that we believe hold enormous
potential for success when built on the current discovery base. Our goal
is to assure that the Nation's cancer research resources are used as effectively
as possible.
For the five areas that are ready for investment, with additional resources,
the NCI will be able to accomplish the following.
* In cancer genetics--expand and integrate basic, clinical, and epidemiologic
research, facilities and training in cancer genetics to identify and characterize
genes responsible for inherited predisposition to cancer; develop diagnostic
tests for alterations in these genes; provide training in genetic counseling
and in cancer genetics for health professionals; and develop the informatics
for collecting, storing, analyzing and integrating the resulting molecular,
epidemiologic, and clinical data. Goals: Identify within 5 years every
major human gene predisposing to cancer; transform medical practice with
this knowledge; and address the psychosocial, ethical and legal issues associated
with cancer genetics.
* In preclinical models of cancer--develop new preclinical models of cancer
to study mutations likely to drive human cancers, provide a natural setting
for studying all stages of tumor development, and allow testing of cancer
prevention and detection strategies, as well as new treatment regimens.
Goals: Create animal models of human cancers and build the experimental
foundation to use these models effectively, and develop the infrastructure
and procedures to make these models available to all researchers.
* In detection technologies--improve early detection methodology through
identification of the unique secreted proteins and mutant genes in body
fluids after exposure to tumor cells as well as improve diagnostic imaging
technology to become more sensitive and specific in order to detect the
fewest number of tumor cells possible. Early detection of tumor products
in a blood sample could signal the presence of small numbers of tumor cells,
providing opportunities to detect tumors at their earliest stages. Goals:
Develop new methodologies that will allow the detection of much smaller
numbers of tumor cells than ever before; discover and develop techniques
that will further increase the precision, accuracy, and scope of imaging
diagnosis; and integrate imaging further into the practice of clinical oncology.
* In developmental diagnostics--improve and expand the diagnosis of cancer
by applying the molecular characterization of cancer cells to fundamentally
change the care of cancer patients. The understanding of tumor properties
will detail key differences between a normal and cancer cell, providing
a molecular profile. This profile can then be used to develop and choose
effective therapies and to plan patient care. Goals: Develop diagnostic
tests that will allow treatment choice to be based on the fundamental properties
of a tumor cell.
* In investigator-initated research--expand investigator-initiated research
by funding a higher percentage of grant applications. Goals: Expand
the number of new and renewal investigator-initiated research grants funded
each year by over 30 percent, to capture the opportunities of new ideas
as rapidly as possible.
