Executive Summary

The National Cancer Institute's goal is to stimulate and support scientific discovery and its application to achieve a future when all cancers are uncommon and easily treated. NCI works toward this goal in two major ways.

• We provide vision to the Nation and leadership for NCI-funded researchers across the United States and around the world.
• We work to ensure that the results of research are used in clinical practice and public health programs to reduce the burden of cancer for all people.

Each year, we support some 5,000 principal investigators in the pursuit of a broad range of research from studies of the causes and incidence of cancer, to translational research and clinical trials, to survivorship and end-of-life issues. NCI also funds cancer centers, collaborative research teams, cancer control, and training, education, and career development activities.

Our future planning encompasses three key components required for a strong cancer research enterprise:

• Maintain a sound research infrastructure and build capacity for the future (NCI's Challenge).
• Capitalize on opportunities in broad scientific areas (Extraordinary Opportunities for Investment).
• Assess and plan for research related to specific types of cancer, such as breast or lymphoma (Planning National Agendas for Disease-Specific Research).

Our total Fiscal Year 2003 Budget Request is $5,690,000. This represents an increase of $1,512,796 over the Fiscal Year 2002 President's Budget. Of this increase, $305,753 will be provided to continue NCI commitments into 2003 (Core Budget). An additional $878,193 will be used for NCI's Challenge, and $328,850 will support Extraordinary Opportunities for Investment. Funding for disease-specific research is included in nearly all of the Challenge and Opportunity areas.

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NCI's Challenge

Major breakthroughs depend on building and sustaining the strong research mechanisms, support structures, and collaborations that will enable us to pursue rapidly evolving discoveries in all areas of cancer research. NCI must provide the vision, creative environments, and diverse resources needed to ensure a smooth flow between advances in knowledge and their application.

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Enhancing Investigator-Initiated Research

Investigator-initiated research has always been the driving force behind advances in biomedical research. Our challenge is to provide scientists with opportunities to pursue as many promising research ideas as possible while at the same time supporting each project with sufficient funds to cover the growing costs of research. NCI gives special consideration to proposals from clinical researchers and those who respond to announcements of priority research areas. We seek to maximize the pace of discovery by providing a broad range of flexible funding options and promoting collaborations and resource sharing.

With increased funding in 2003, we will:

• Support research projects at the full levels recommended by peer reviewers and fund the top 35 percent of competing grant applications.
• 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, and that exceptions funding is available to support particularly innovative and potentially high reward projects.

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Centers, Networks, and Consortia

The rapid pace of scientific and technological discovery is creating opportunities that require interaction among scientists of diverse backgrounds, sometimes located in physically distant sites. The challenge for NCI is to create research settings that encourage the multidisciplinary collaborations needed to address the big picture problems in cancer research. To meet this challenge, we continue to support NCI-designated Cancer Centers, Centers of Research Excellence, and various research networks and consortia that enable scientists from different disciplines to work together, share information and resources, and experience the synergism that often catalyzes new discovery.

In 2003, NCI will use new funding to:

• Increase support to Cancer Centers for new technology development, improved informatics capabilities, and clinical and population research infrastructure.
• Expand and enhance the Specialized Programs of Research Excellence based on needs for disease-specific research.
• Implement a Strategic Supplement Program to take advantage of high priority opportunities that can be completed in short time frames.

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National Clinical Trials Program in Treatment and Prevention

Our intricate clinical trials system relies on cooperation and collaboration among patients, investigators, industry, academia, and NCI. Adding to this complexity, cancer clinical trials have undergone dramatic changes in recent years, as the result of progress in cancer biology, imaging technology, and advances in informatics and electronic communications, generating both the need and the possibility for more trials involving much larger numbers of health care providers and patients. While NCI-supported clinical trials have incorporated many changes, reimbursement to health care providers has not kept pace and participation in clinical trials remains lower than ideal. Our challenge is to minimize the barriers to participation in clinical trials while ensuring that we capitalize on the latest developments in cancer research, informatics, and management.

With adequate funding in 2003 NCI will be able to:

• Improve patient access to and the rate at which trials are completed by increasing the per patient reimbursement for trials, doubling the number of patients accrued to trials, providing funding for healthcare providers to follow patients and report outcome and other data, and expanding the Clinical Trials Support Unit.
• Expand funds for clinical correlative studies, fund tissue and specimen banks, create collaborations for multi-institutional clinical trials, and step up development and assessment of promising targeted prevention and treatment agents.

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Studying Emerging Trends in Cancer

NCI must continue to build a versatile cancer surveillance system that fully represents the diversity of our nation's population and more accurately tracks the Nation's cancer burden. This information is needed to help researchers form hypotheses and to provide communities with the information they need to strengthen cancer prevention and control. NCI works with partners to develop a more robust system, create analytical tools for research and cancer control, and find effective ways to disseminate surveillance information.

In 2003, we will use additional funding to:

• Augment and refine our surveillance system.
• Keep pace with a rapidly changing cultural, social, and technological milieu.
• Continue to build systems that better track cancer trends, highlight research needs, explain causes of cancers, identify individuals at greatest risk, and support community cancer control.

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Quality of Cancer Care

The quality of cancer care is a major national concern. Evidence suggests that some patients with cancer do not receive the newer, more effective treatments, and there is often uncertainty about what constitutes optimal care. To address these concerns, NCI is helping to enhance the information base for cancer care decision making through improvements in data collection and the development of better measures for comparing cancer treatments and outcomes. Furthermore, we are also investing in studies to examine the quality of cancer care and in demonstration projects to ensure that the delivery of care reflects the latest findings from cancer research.

With funding increases in 2003, NCI will engage in activities to:

• Improve measurement of patient-centered outcomes in cancer.
• Support innovative research on the diffusion, quality, and outcomes of cancer interventions.
• Enhance quality-of-care research within the NCI clinical trials program.

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Reducing Cancer-Related Health Disparities

To effectively reduce cancer-related health disparities, NCI must make new research investments to explain the 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. Our efforts include support to the NCI-sponsored Special Populations Networks for Cancer Awareness Research and Training, examination of specific ways in which cancer incidence and mortality are disproportionate for certain populations (e.g., cervical cancer in rural U.S.), development of patient education materials for low-literacy populations, collaborations to increase access to and involvement in clinical trials, and training for new scientists focused on health disparities.

In 2003, we will use funding increases to:

• Expand our research efforts in gap areas.
• Foster better dissemination and use of research findings.
• Further increase access to clinical trials by special population groups.
• Support new Centers for Population Health and Cancer and special grants for continuing education of health care providers.

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Informatics and Information Flow

To assist the cancer research community in keeping pace with the flood of information stemming from new scientific discovery, NCI needs to develop and provide informatics systems that facilitate resource sharing and the translation of emerging findings into public health benefits. NCI has built a Cancer Informatics Infrastructure to supply standardized bioinformatics support and integration of NCI's diverse research initiatives. Within this framework, we are developing the innovative tools required to connect people with necessary information.

In 2003, we will use funding increases to:

• Enhance integration of the data and tools resulting from NCI's priority initiatives.
• Establish informatics applications and services based on a common set of operating principles and standards and make them available to cancer researchers.
• Support planning and public communication activities.
• Establish a network of bioinformatics research centers.
• Provide funding supplements to NCI-supported research organizations for development of informatics systems.
• Promote informatics training for biomedical research settings.

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Cancer Research Training and Career Development

Scientists of the future will need to be trained in multiple disciplines, able to work in teams to understand the multifaceted nature of cancer, and better prepared to translate discoveries into public benefit. NCI is employing a variety of individual and institutional training and career development awards to meet the needs of new and established investigators and NCI's anticipated research priorities. We have focused increased resources on career development for M.D.s in cancer research, behavioral and population scientists, minority scientists, and scientists in highly technical fields important to the future of cancer research. We also are more effectively integrating education programs for health practitioners and the public through improved national networking and use of communication technologies.

We will use new funding in 2003 to:

• More adequately prepare scientists to work in multi-disciplinary environments.
• Reverse the migration of physicians from research to practice.
• Increase the number of population, behavioral, and public health scientists.
• Create a research workforce that is ethnically and racially diverse.
• Attract and integrate technical and informatics experts into cancer research.

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Extraordinary Opportunities for Investment

NCI's focus on six priority areas with extraordinary potential to impact the pace and direction of cancer research have shown significant results and will be continued into 2003.

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Genes and the Environment

As we better understand the interplay between inherited susceptibility to cancer and environmental risk factors, we will be able to develop more meaningful approaches to cancer prevention, early detection, and treatment. NCI has begun building capacity in this area through consortia of investigators who are pooling data and resources to compile the large data sets required for this kind of study. We also are examining approaches for assessing and measuring environmental exposures, advancing research to discover and characterize cancer predisposing genes, and supporting the development of a number of tools for use in gene discovery and characterization such as mouse models of human cancers. We also have established an infrastructure to support intervention trials on inherited susceptibility to cancer.

In 2003, NCI will use new funding to:

• Support studies to identify additional environmental risk factors and susceptibility genes and determine their interactions.
• Develop new ways to assess and measure environmental exposures.
• Identify and investigate how other genes and environmental factors modify the expression of cancer predisposing genes.

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Cancer Imaging

With the power of new imaging technology, researchers and health care providers can generate much clearer and more detailed pictures of organs and tissues, and they can use "functional imaging" for the visualization of physiological, cellular, or molecular processes in living tissue. NCI has supported In Vivo Cellular and Molecular Imaging Centers to provide essential infrastructure and career stability to investigators in this emerging field. We also are fostering the development of new imaging contrast agents and molecular probes, making equipment and personnel available to improve technologies and techniques for imaging small animals, and assessing the value of computed tomography scanning in screening patients for colon cancer ("virtual colonoscopy").

With new funding in 2003, NCI will be able to advance imaging technology development and use by:

• Expanding the discovery, design, and development of novel imaging agents and devices.
• Integrating molecular and functional imaging methods into therapeutic clinical trials.
• Increasing clinical trials of imaging methods and technologies.
• Accelerating the development and clinical testing of image-guided interventions.

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Defining the Signatures of Cancer Cells

With the aid of new technologies, scientists are working to read and understand the unique, identifiable characteristics of cancer cells known as molecular signatures. Our ability to read these signatures will allow us to differentiate among tumors at the molecular level and devise treatments targeted at specific cancers. NCI provides researchers with a variety of resources for study in this area such as catalogs of molecular changes in cancer, tissue resources, and informatics tools. The Early Detection Research Network has begun describing molecular signatures that may be used for the early detection of breast, esophageal, and other cancers.

New funding in 2003 will be used to:

• Expand the development and availability of molecular and analytic resources.
• Make tissue resources available to researchers.
• Apply molecular signatures to the study and validation of animal models for human cancer.
• Support new approaches for the early detection and diagnosis of cancer.
• Characterize aberrant molecular interactions in cancer.

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Molecular Targets of Prevention and Treatment

Our increasing knowledge of the molecular changes that cause a cell to become cancerous is opening a whole new avenue to drug development. Agents that target these molecular changes have potential to selectively delay, stop, or reverse the growth of cancer cells without harming surrounding healthy tissue and promise to be less toxic and more effective than current drugs. To respond to this research opportunity, NCI has rallied the necessary resources for laboratory, animal, and clinical studies and has begun to identify numerous potential molecular targets as an early step in cancer prevention and treatment drug discovery.

NCI will use new funding in 2003 to:

• Distinguish and use cellular targets for the discovery of new anti-cancer agents.
• Develop assays to identify possible treatments for cancer.
• Acquire large libraries of natural and synthetic compounds.
• Develop a translational research program that will closely link molecular imaging, cancer signatures and molecular targets.
• Facilitate the steps necessary to turn a compound into a targeted drug ready for clinical use.

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Research on Tobacco and Tobacco-Related Cancers

The devastating impact of tobacco use and tobacco smoke exposure on the incidence of cancer is both compelling and conclusive. We need to better understand the genetic, biological, behavioral, and social components of tobacco use, addiction, smoking cessation, and how to prevent, detect, and treat tobacco-related cancers. New evidence is helping to better explain why some people are more vulnerable than others to DNA damage caused by tobacco exposure. Research on the early detection of lung cancer suggests that it may soon be possible to identify cancers in smokers and former smokers at a much earlier and more treatable stage. Recent studies of teen smokers have identified psychological factors that increase the risk of becoming addicted.

NCI will use new funds in 2003 to:

• Expand efforts to define the biological, behavioral, and social bases of tobacco use and addiction.
• Accelerate progress in understanding the interplay among tobacco, other exposures, and genetic susceptibility.
• Develop, test, and disseminate more effective interventions to prevent and treat tobacco use and tobacco-related cancers.

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Cancer Communications

People now have more ways than ever to get information, and the future holds even more choices. NCI is working to optimize the use of communication tools to meet the information needs of various groups while enhancing the absolutely essential interaction of patients with their doctors and nurses. Digital Divide Pilot Projects have demonstrated the potential for using computer technology to address the information needs of underserved populations. Five new Centers of Excellence in Cancer Communications Research will be established in 2002 to encourage focused interdisciplinary studies, increase the number of investigators, and train scientists to conduct cutting-edge research directly.

In 2003, we plans to:

• Expand activities to more fully address the communication needs of underserved populations.
• Continue the Centers of Excellence.
• Provide support for the dissemination of research results.
• Add to the menu of communication choices available for information about cancer.

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Planning National Agendas for Disease-Specific Research

While we have learned much that is broadly applicable to cancer through our core research programs and Extraordinary Opportunity initiatives, NCI must be equally alert to the specific tendencies and behaviors of each unique type of cancer. This is why NCI plans, promotes, and carries out an ambitious program of disease-specific research, charting the course for these efforts primarily through advice from experts participating in Progress Review Groups (PRGs).

NCI carefully addresses PRG recommendations by

• Modifying and supplementing existing research programs
• Encouraging scientists to apply for disease-specific research funding.
• Developing new initiatives when needed.

PRGs have been completed or are underway for breast, prostate, colorectal, pancreatic, lung, gynecologic, kidney and bladder cancers, brain tumors, and leukemia, lymphoma, and myeloma. PRGs on stomach/esophageal, liver/bile duct, and skin cancers are planned.

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The Nation's Investment in Cancer Research

NCI's Budget Request for Fiscal Year 2003

(dollars in thousands)

Base of Fiscal Year 2002 President's Budget	$4,177,204
Increase to Core Budget	305,753
NCI's Challenge Increase
Enhancing Investigator-Initiated Research	121,543
Centers, Networks, and Consortia	81,250
National Clinical Trials Program	433,000
Studying Emerging Trends in Cancer	22,700
Quality of Cancer Care	14,000
Reducing Cancer-Related Health Disparities	52,700
Informatics and Information Flow	95,000
Cancer Research Training and Career Development	58,000
Subtotal Challenge	878,193
Extraordinary Opportunities Increase
Genes and the Environment	55,500
Cancer Imaging	69,800
Defining the Signatures of Cancer Cells	75,000
Molecular Targets of Prevention and Treatment	42,500
Research on Tobacco and Tobacco-Related Cancers	67,000
Cancer Communications	19,050
Subtotal Opportunities	328,850
Total FY 2003 Budget Request	5,690,000

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