Executive Summary

The goal of the National Cancer Institute is to achieve a future when all cancers are controlled or eliminated, by stimulating and supporting research and its application. We provide vision and leadership to the cancer community as we strive to more fully integrate discovery activities through interdisciplinary collaborations, to accelerate the development of interventions and new technology through translational research, and to ensure the delivery of these interventions through clinical and public health programs.

Recent reports indicate that overall cancer death rates decreased from 1993 to 1999, while rates of cancer incidence stabilized over a similar timeframe. More people are getting screened for breast, cervical, and colorectal cancers, and more practitioners are adopting state-of-the-art cancer treatments. But we still need to employ greater efforts to reduce tobacco use, weight gain, and sun exposure and to increase physical activity. We also need to reduce rates of some cancers that are still on the rise. These include non-Hodgkin's lymphoma, melanoma, cancers of the liver and esophagus, as well as breast and lung cancer in women.

Trends in various population groups differ substantially by cancer site, sex, and race, and we must redouble our efforts to eliminate persistent cancer-related health disparities. Because of the increasing size of the population and the growing proportion of older persons, researchers expect the cancer burden in the United States to increase substantially over the next several decades. Our changing age structure will require aggressive strategies for cancer prevention and early detection, social support, treatment and medical care, clinical trial design and enrollment, research, and surveillance. In addition, access to supportive, palliative, and general medical services must be optimized.

The framework for the NCI budget is built on priorities that are broadly applicable to cancer research and development and our ability to prevent, control, detect and quickly diagnose, treat, and care for patients with all types of cancer. Within that framework, NCI also carries out an extensive program to develop National Agendas for Disease-Specific Research, charting the course primarily through advice from experts in Progress Review Groups (PRGs). We address PRG recommendations by modifying and supplementing existing research programs, encouraging scientists to apply for disease-specific research funding, and developing new initiatives when needed. NCI supports research focused on specific types of cancer through broad-based initiatives such as the Specialized Programs of Research Excellence, the Early Detection Research Network, the Innovative Molecular Analysis Technologies Program, and the Mouse Models of Human Cancers Consortium. Funding for disease-specific research is an integral part of many NCI initiatives.

Our total proposed Fiscal Year 2004 Budget Request is $5,986,000,000. This represents an increase of $1,348,131,000 over the Fiscal Year 2003 President's Budget. Of this increase, $294,014,000 will be provided to continue NCI commitments into 2004 (Core Budget). An additional $577,517,000 will be used for Building the Nation's Cancer Research Capacity, $266,250,000 will support Advancing Discovery and Its Application, and $210,350,000 will fund research for Addressing Areas of Public Health Emphasis. While we are not requesting increases in funding for Cancer Research Training and Career Development or for Studying Emerging Trends, these continue to be priorities for NCI.

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Building the Nation's Cancer Research Capacity

Bringing the benefits of cancer research to the American people depends on building and sustaining the strong research mechanisms, support structures, and collaborations that enable us to pursue rapidly evolving discoveries. NCI must provide the vision, creative environment, and diverse resources needed to ensure a fast paced and synergistic flow of innovative thinking among scientists in disparate scientific disciplines. We must also leverage our collaborations with other government agencies, academia, and industry, focused on steering major breakthroughs toward the delivery of effective cancer interventions.

Investigator-Initiated Research has always been the driving force behind advances in biomedical research. Access to powerful new tools, special resources, and scientific collaborations are increasingly important to an investigator's ability to develop the independent concepts that lead to discovery and translate results to targeted drugs and treatment. NCI aims to balance the flow of resources to ensure that the best ideas are promoted through flexible funding options such as cooperative agreements, seed funds, and supplemental funds for unanticipated opportunities. Compelling proposals are supported with exceptions funding, particularly those suggesting novel approaches. Expert NCI advisory panels and Progress Review Groups continue to identify priority research and recommend funding. With increased resources in 2004, we will be able to fund the top 35 percent of competing grant applications using flexible criteria and continue to allocate the first 80 to 90 percent of available funds for research project grants through conventional selection processes, while ensuring that proposals from new investigators are also funded.

NCI-supported Centers, Networks, and Consortia encourage the interdisciplinary collaborations needed to address the "big picture" problems in cancer research and integrate clinical observations with research investigation. The rapid pace of scientific and technological discovery requires that scientists of diverse backgrounds work together to share information and resources. In 2004, NCI will use new funding to increase the number and geographic distribution of Cancer Centers, providing service to regional communities in addition to expanding crosscutting research capacity. Cancer Centers will serve as platforms to support new technology development, improve informatics capabilities, and conduct more clinical and population research. Specialized Programs of Research Excellence will be expanded based on needs for disease-specific translational research. Underserved and minority populations will have improved access to the newest trials and state-of-the-art care through partnerships with NCI-designated Cancer Centers, Minority-Serving Institutions, and NCI Special Populations Networks.

NCI's National Clinical Trials Program in Treatment and Prevention provides a versatile system to safely move emerging cancer interventions into health care delivery. NCI's challenge is to provide the leadership demanded by the emerging paradigm of molecular targeted therapy in cancer treatment and prevention. With adequate funding in 2004, NCI will be poised to identify the most important questions that can be addressed through clinical trials; create the flexible mechanisms and support that will bring together basic scientists and clinicians to find the answers; fund tissue and specimen banks; help develop surrogate endpoints for use in small translational trials; move the most promising interventions into large and easily accessible trials; and simplify administration activities while increasing patient accrual, to substantially increase the number of new treatments and other interventions being evaluated. With sufficient funding, we can make state-of-the-art clinical trials and the ensuing discoveries available to all who can benefit from them.

Bioinformatics for Cancer Research will help us harness the growing flood of scientific information using NCI's systems for resource sharing and for translating pioneering research into better medicine. Virtual experiments will use data from multiple sources. We will generate hypotheses and create and manage more knowledge faster with systems that standardize, support, and integrate information from our diverse research. caCORE, a standards-based cancer knowledge resource, makes possible in silico experiments with the Cancer Models Database, Cancer Genome Anatomy Projects, and the Cancer Therapy Evaluation Program. For example, participants in the Cancer Molecular Analysis Project locate and assess possible molecular targets, find therapeutic agents, screen for toxicity, and identify clinical trials. Bioinformatics holds impressive potential for facilitating cancer diagnosis, as demonstrated in the recent marriage of proteomics and artificial intelligence that resulted in a promising ovarian cancer-screening test. In 2004, NCI will use new funds to expand our own informatics infrastructure and the informatics capacity of the research community.

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Advancing Discovery and Its Application

Increased investment in broad scientific opportunities and emergent fields of research that lie beyond the size and scope of our current research activities allow us to accelerate the pace of discovery. Better understanding our audiences and their needs allows us to facilitate application of research results in the clinic and public health programs, to benefit all people affected by or at risk for cancer.

The study of Genes and the Environment increases our understanding of the interplay between individual inherited susceptibility to cancer and environmental risk factors, enabling the development of more effective approaches to cancer prevention, early detection, and treatment. NCI is investing in this area through large-scale collaborations, such as the Cohort Consortium, by bringing epidemiologists, genomicists, and other investigators together to pool data and resources for large population studies. NCI Cancer Family Registries provide resources for the characterization of predisposing genes found in families at high risk for cancer. In 2004, NCI will use new funding to identify additional environmental risk factors and susceptibility genes and determine their interactions in cancer causation; identify genes in high-risk families and investigate how other genes and environmental factors modify them; and support collaborative studies of the clinical, behavioral, and societal issues associated with cancer susceptibility.

All cells have "molecular signatures" - unique, identifiable characteristics related to a cell's function in the body. As a normal cell becomes malignant, its signature changes and this change becomes a signal of the presence of cancer. Research on Signatures of the Cancer Cell and Its Microenvironment focuses on identifying the signatures of both cancer cells and "co-conspirator" cells in the surrounding microenvironment that interact with cancer cells to encourage tumor growth. With new technologies, scientists are reading cancer-associated signatures and using this information to detect cancers at their earliest stage, to diagnose and classify tumors according to their molecular profiles, and to devise treatments that selectively target molecular signatures. Several large initiatives are already making important progress in these areas. New funding in 2004 will be used to define and characterize the molecular signatures of cells in the cancer microenvironment at various points during cancer initiation and progression; to define how communication among cancer cells, surrounding cells, and immune cells controls or promotes tumor growth; and to create targeted interventions based on this new knowledge.

Our ability to decipher the molecular basis of cancer has launched an exciting new era in biomedical research as we hone in on Molecular Targets of Prevention and Treatment. Researchers are directing a new generation of low toxicity, high efficacy agents against the molecular features, or targets, that cause tumor growth. NCI is using a multi-disciplinary approach to discover ways to trigger the cancer cell to revert to normal, stop replicating itself, or self-destruct. Other strategies harness the immune system to combat the cancer or prevent surrounding tissues (the "tumor microenvironment") from supporting cancer growth. NCI will use new funding in 2004 to characterize potential targets; support basic and clinical research to validate drugs developed to hit the targets and move them into clinical use; investigate combinations of radiation therapy with molecular therapeutics; and develop the next generation of cancer vaccines. This work will speed development of interventions against cancer, based on the unique molecular characteristics of each patient's tumor.

Investment in Cancer Imaging and Molecular Sensing has dramatically improved cancer detection, diagnosis, and treatment. Experimental, molecule-size biosensors that can be injected into the bloodstream promise even more options for patient care. NCI's challenge is to improve imaging and biosensor technologies to ensure earlier, more accurate cancer diagnoses, individualize therapies, use fewer invasive interventions, and improve patient monitoring. Accordingly, NCI is improving functional imaging, developing molecular and digital imaging databases, building micro-imaging techniques for animal research, and supporting biosensor research. Through clinical trials and public-private partnerships, we are moving promising imaging advances from discovery and development to clinical use. With new funding in 2004, NCI will be able to expand development of novel imaging agents and devices; increase clinical trials of imaging technologies, such as the National Lung Screening Trial; integrate functional imaging methods into therapeutic clinical trials; advance image-guided interventions; and stimulate research on biosensors. Significant advances in these areas will increasingly save and improve lives.

Cancer Communications empowers people to make informed cancer-related decisions and adopt behaviors to improve their health. NCI is working to optimize the use of communications tools to meet the information needs of all groups while building strategies to enhance the important interaction between patients and their doctors and nurses. Lives are saved through communication interventions that decrease or prevent smoking, influence good nutritional choices, and increase the number of people who are screened to detect cancer early. Enhanced NCI databases and Web sites include user friendly topical formats and clinical trials information. In 2004, NCI plans to establish new data collection and analysis strategies, including the first national health communications survey of U.S. populations; accelerate the pace of research and development of communications interventions; increase access to and use of cancer information; and improve our understanding of and ability to effectively move research results into clinical practice and public health programs.

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Addressing Areas of Public Health Emphasis

Progress against cancer takes place not only in the laboratory and the physician's office, but also within broad public health programs. NCI has identified four areas to more fully address cancer care and its consequences and translate research into full application for people affected by cancer.

The Quality of Cancer Care is a major national concern. Barriers to high quality care include system and financial limitations, proximity of healthcare facilities, available education and information, and physician and patient biases. To address these concerns, NCI is helping to ensure that the best available scientific evidence guides cancer care decision making. NCI is supporting the Cancer Care Outcomes Research and Surveillance Consortium and other studies to strengthen the science base for understanding palliative care and symptom management and end-of-life distress as well as examining depression in cancer patients. With funding increases in 2004, NCI will engage in activities to improve methodology and measurement of patient outcomes; support innovative research on the diffusion, quality, and outcomes of cancer interventions and its translation to best practices in patient care; enhance quality-of-care research within the NCI clinical trials program; strengthen cancer communications; and inform science-based Federal decision making.

Effectively Reducing Cancer-Related Health Disparities requires new understanding to explain social, cultural, environmental, biological, and behavioral determinants of cancer, the interactions among them, and the mechanisms by which they contribute to disparities in cancer care and prevention. NCI continues to address disparities among all population groups through numerous initiatives such as the establishment of new centers focused on disparities research, the Cancer Prevention Fellowship Program, and the implementation of a landmark study to determine factors that contribute to cancer among groups hardest hit by the disease. In 2004, we will use funding increases to expand our research on the causes of health disparities in cancer; define and monitor disparities; develop and implement new policy, community, and clinical interventions, and evaluate their impact; and expand minority investigator competition for, and minority population involvement in, health disparities research and clinical trials.

Through statistics on Cancer Survivorship, we are beginning to see the fruits of the "War on Cancer" launched in 1971. Once almost uniformly fatal, cancer has become a chronic illness for many and, for growing numbers of people, a curable disease. Fewer deaths from other diseases and the aging of the population also contribute to the rising number of cancer survivors. However, we have many questions about the health status and quality of life for most patients in their post-treatment years. What is clear is that most of our current treatments will produce some measure of adversity. NCI is initiating a focused effort in 2004 to understand the mechanisms that affect a cancer patient's response to disease, treatment, and recovery; develop tools to assess quality of life following treatment; track outcomes for cancer survivors; disseminate clinical guidelines; and expand the scientific base for understanding the adverse late effects of current and new cancer treatments.

Research on Tobacco and Tobacco-Related Cancers is driven by the devastating impact of tobacco use and tobacco exposure on the incidence of cancer. Tobacco use causes more premature death (approximately 430,000 per year in the United States) than do all drugs of abuse combined. NCI research is focused on improving understanding of tobacco-related addiction and carcinogenesis, including the role of genetic and environmental factors in smoking initiation, persistence, and relapse. Through several new initiatives, including the Lung Cancer Screening Study as well as preclinical and clinical studies to identify more potent agents for cancer prevention, NCI-supported research is targeting the health needs of current and former smokers. NCI will use new funds in 2004 to expand the infrastructure needed to conduct a vigorous research program; support investigations to understand and treat tobacco use and addiction; and apply cutting edge research to better understand and treat tobacco-related cancers.

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NCI's Budget Request for Fiscal Year 2004

(dollars in thousands)

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