The most important component of the NCI research program is investigator-initiated research. It is the life-blood of science and the cornerstone of the National Cancer Institute. Over one-half of the Institute's budget is devoted to such research, which is funded under a variety of peer-reviewed grant mechanisms designed to optimize the purpose of the research and the likelihood of project success. There are mechanisms focused on single projects undertaken by single investigators; on Program Projects that enable a team of investigators to develop a group of related projects, which by being carried out together will achieve more than if each were carried out singly; on first awards for new investigators to enable them to rapidly develop a foothold in science; and on small business and industry-academic collaborators.
Peer review is fundamental to investigator-initiated research. A grant proposal/application submitted to the NCI is reviewed by one of more than 100 committees (termed study sections or peer review groups) composed of scientists in fields closely related to the applicant's research. The reviewers give each grant a score reflecting the importance of the topic proposed, the rigor of the study design, and the investigator's ability to achieve the aims of the research. With the assistance of its principal advisory body, the presidentially-appointed National Cancer Advisory Board, the NCI examines each of the grants submitted, weighs the evaluation of the peer review groups, then critically assesses cancer research priorities and its budget in order to make funding decisions. Unfortunately, worthy scientific opportunities far outweigh the budget--only 25 percent of grants judged eligible for funding by the peer review groups actually receive funding.
To carry out research requires an extensive set of mechanisms, organizations, and networks linking researchers, facilities, and information. This infrastructure supports cancer research through diverse endeavors including developing central resources in tissue and data banking; conducting directed programs in drug discovery and large-scale screening for preventive agents, tracking changes in cancer incidence, mortality, and morbidity; and fostering the critically needed training of cancer researchers.
Like investigator-initiated research, most components of the infrastructure are funded through grants and evaluated through peer review, including a network of Cancer Centers, Community Clinical Oncology Programs, and Clinical Trials Cooperative Groups. Other components are funded under contract, such as the Surveillance, Epidemiology and End Results Program, a network of cancer registries providing surveillance information on cancer incidence, mortality, and survival. The NCI's Frederick Cancer Research and Development Center is also funded under contract, and all contracts are evaluated through a peer-review mechanism.
The purpose of research is to develop understanding. The NCI's cancer research funding strategy is to assure that there is sufficient funding to enable scientists to pursue those research areas with the greatest scientific opportunity--that is, the greatest opportunity to increase our knowledge of cancer. Research on cancer involves activities from the most fundamental laboratory research to large-scale trials of cancer prevention and treatment methods. Funding decisions are based principally on the advice of scientists themselves as to those areas and projects that have the greatest potential to expand our knowledge of cancer. This expansion can occur in ways that at first may seem unlikely. For example, research on families who have a propensity to develop breast cancer has shown they also have a higher risk of ovarian cancer and perhaps prostate cancer, revealing unexpected linkages between these cancers. And, research on the viral causes of cancer led to the identification of the gene p53, now understood to be a tumor suppressor gene whose loss of function is important in the development of more than 50 percent of all cancers.
A second critical factor that guides program direction, in addition to scientific opportunity, is the burden of specific cancers. For example, breast cancer, the leading cancer among women, with more than 184,000 new cases each year, is a major priority for the NCI. Prostate cancer is the leading cancer among men and, in fact, the single cancer with the greatest number of new cases each year--more than 300,000. Both of these cancers involve steroid hormone-dependent epithelial cells, and the tools and insights required to make progress against both are difficult to separate. Research on the hormonal aspects of testicular cancer, a relatively rare cancer with about 7,000 cases annually, may well provide clues to breast and prostate cancers as well. There is no research allocation schema that can account for these essential inter-relationships between cancers. Advances against one type of cancer may well affect every other type of cancer, and may occur in fundamental and applied research. These advances come from both targeted and, more often, non-targeted research that has the potential to apply to all cancers.
This budget estimate, unlike those submitted in years past, outlines two vitally important but different levels of national investment in cancer research.
The first level of investment is essential to enable current cutting-edge research to advance. It is sufficient to assure stability, continuity, and progress in NCI's existing research programs in laboratory, clinical, and population studies aimed at the prevention, detection, diagnosis, and treatment of cancer, and the rehabilitation of cancer patients. It is through these core research programs that we have achieved some of the most important recent advances in cancer, bringing us to a threshold of unprecedented opportunity. This first level of investment, however, is not sufficient to allow us to capitalize on these extraordinary opportunities.
The second level of investment enables the Nation to build rapidly on these enormous advances in knowledge and technology through a significant expansion into crucial new areas of research. These distinct new research areas cannot be pursued substantially under current fiscal constraints without damage to other vital research now underway. The proposed additional investment augments the core research program across the spectrum of inquiry into cancer biology, cancer risk, cancer intervention, and cancer control.
Progress against cancer depends on a balanced program across laboratory studies and research on cancer risk, treatment, detection, prevention, and control. Over the past year, the NCI has made many changes in organization and programs to reach an appropriate balance. We have reduced intramural research contract levels, improved fiscal management of the intramural program, and expanded the base of extramural research. These changes represent both a scientific realignment and significant economies, but they are insufficient to enable us to grasp these exceptional opportunities for progress now within our reach. If we reduce current expenditures to pursue these new opportunities, we will undercut fundamental ongoing research on, for example, how cancer spreads from one organ to another, on the efficacy of a new prostate cancer treatment, or the impact of diet on breast cancer risk.
In 1971 Congress passed the National Cancer Act, increasing resources
for cancer research and broadening the mandate of the National Cancer Institute,
the principal Federal agency supporting and conducting cancer research.
Today, some 25 years later, we have made progress against many cancers,
but the most profound change has been in our understanding of the fundamental
biology of this constellation of diseases. It was the infusion of funds
following the National Cancer Act that led to the genetic revolution in
cancer and biomedicine in general. These funds spurred research on the leading
causes of cancer and led to new treatments for children's cancers, colon
cancer, Hodgkin's disease, testicular cancer, and breast cancer. Taxol®
is one of many new anti-cancer drugs that can be directly attributed to
this increased effort. These funds were instrumental in the development
of the biotechnology industry and in helping to fight diseases other than
cancer. For example, the early study of retroviruses funded by the National
Cancer Institute has been critical to advances in AIDS research and treatment
and our understanding of cancer as well.
Over the last decade, however, the resources to fight cancer have barely
kept up with inflation. We find ourselves with opportunities for investment
in every facet of cancer research, but these opportunities now greatly outstrip
our resources.
Limited aspects of each new investment area will be pursued under the core, maintenance level budget, as projected here for FY 1998. But achieving the goals and reaching the milestones outlined in this document will require more resources than can be redirected from the core budget. Sustaining a strong National Cancer Program and reducing the burden of cancer with all possible speed require that we pursue these multiple strategies of research, maintaining a solid foundation, and seizing opportunities when they present themselves.
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