Introduction

In 2001, the National Cancer Institute (NCI) issued the nationwide cancer community this Challenge Goal: To eliminate suffering and death due to cancer by 2015. Never before have so many scientific tools and technologies and so much biomedical knowledge been assembled to power our ability to reach our Challenge Goal. We are experiencing exponential growth in our knowledge of cancer, growth fueled by historically high levels of funding, scientific expertise, infrastructure, and enabling technologies. With a sharp focus on our goal and continued budgetary support, we can harness advances in discovery and development research to deliver interventions for preventing cancer; detecting it early; and slowing, stopping, or reversing its progression to a lethal phenotype.

Our success will depend on our ability to integrate our activities, from the discovery of new scientific knowledge, to the development of new interventions, to the delivery of evidence-based interventions to all who need them. We must work to remove the major barriers that impede progress and ensure that all new activities are informed by past lessons learned. Most importantly, we must maintain our momentum so that the progress we have made thus far turns into the promise of a better future for those with, or at risk for, cancer.

As the leader of the National Cancer Program, NCI provides vision and direction to the nationwide community of researchers, public health workers, healthcare providers, patients, advocates, and policymakers working to defeat cancer. Our budget has historically reflected this crucial role. NCI's total proposed Fiscal Year 2005 Budget Request is $6,211,000,000. This represents an increase of $1,440,481,000 over the Fiscal Year 2004 President's Budget. Of this increase:

• $329,480,000 will allow us to continue our commitments into 2005 (Core Budget).
• $471,500,000 will be used for new and expanded work in broad research priority areas, with a focus on optimizing opportunities for intervention development and delivery.
• $555,201,000 will allow for additional support to our major research infrastructures or platforms: investigator-initiated research; centers, networks, and consortia; and clinical trials.
• $84,300,000 will be used to improve and expand cancer bioinformatics and communications tools and approaches to enable precise and accelerated research and ensure the translation of discovery to new intervention development and delivery for use in public health programs, clinical practice, and policymaking.

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Disease-Specific Research

"Cancer" is not one, but actually more than 100 distinct diseases. We are learning that many disease sites have cancer subtypes with unique molecular characteristics that influence how they develop and progress and how they can be effectively prevented, detected, and treated. NCI continues to work with cancer research and advocacy communities to identify and address needs for work in specific types of cancer. This year, a Sarcoma Progress Review Group is under way, and NCI disease-specific working groups continue their efforts to follow up on recommendations of other Progress Review Groups convened over the past several years. This kind of disease-specific focus is absolutely critical for achieving our Challenge Goal.

Broad Research Priorities: Optimizing New Knowledge and Opportunities

NCI's action plan for achieving our Challenge Goal includes ongoing research in four core scientific areas and five areas of public health emphasis. Identified with assistance from our advisory boards, the larger research community, and the cancer advocacy community, we believe investment in these areas will allow us to accelerate the pace of discovery and optimize the use of existing and new knowledge for the development and delivery of evidence-based interventions.

• Genes and the Environment
• Signatures of the Cancer Cell and Its Microenvironment
• Molecular Targets of Prevention, Diagnosis, and Treatment
• Cancer Imaging and Molecular Sensing

• Research on Tobacco and Tobacco-Related Cancers
• Optimizing Energy Balance to Reduce the Cancer Burden
• Improving the Quality of Cancer Care
• Reducing Cancer-Related Health Disparities
• Improving Treatment Outcomes and Quality of Life for Cancer Survivors

Core Scientific Areas

As we more fully understand cancer-related molecular, cellular, microenvironment, behavioral, psychological, and social influences, we can develop more effective and less harmful approaches to cancer prevention, early detection, diagnosis, treatment, and control.

Genes and the Environment. Cancer research has benefited enormously from increasingly sophisticated molecular technologies and the resources generated by the mapping of the human genome. Scientists have a better understanding of the complexity of genetic and environmental interactions that lead to cancer development. To build on this understanding, NCI must continue to develop novel ways to study the complexities of genetic and environmental contributions to cancer. With 2005 funding increases, we will:

• Place special emphasis on large-scale interdisciplinary studies to help scientists uncover environmental risk factors.
• Identify genetically susceptible individuals.
• Develop appropriate interventions and precautions for people at high risk.
• Generate new individual and public health strategies to avoid adverse environmental or lifestyle-related exposures.

Signatures of the Cancer Cell and Its Microenvironment. Cancer is not a self-contained collection of malignant cells but rather is integrally associated with its tumor microenvironment, which includes a variety of cell types that are often altered through interaction with cancer cells. Both cancer cells and their surrounding environment need to be fully characterized in order to understand how cancer grows in the body, and both need to be considered when developing new interventions to fight the disease. Scientists are deciphering the "signatures" (signals of the presence of cancer) of cancer cells and cells in the microenvironment. Continued investments will be required in 2005 to continue progress toward defining the full range of molecular signatures for cancer and understanding how interactions among cancer cells and the microenvironment lead to tumor development and metastasis.

Molecular Targets of Prevention, Diagnosis, and Treatment. As we more fully understand the molecular causes of cancer and its development and progression, we can use that information to discover, develop, and deliver agents that specifically "target" these causes. Such molecularly targeted interventions have the potential to dramatically improve the prevention, diagnosis, and treatment of cancer. In 2005, we must expand our efforts to identify, characterize, and validate the combinations of cellular proteins and pathways that cause cancer. And we must significantly increase the number of highly effective cancer interventions that are directed at validated targets.

Cancer Imaging and Molecular Sensing. Cancer research and care are both critically dependent on imaging technologies. Imaging advances are already permitting remarkable accuracy in:

• Detecting whether a tumor has invaded vital tissue, grown around blood vessels, or spread to distant organs.
• Allowing physicians to monitor patient progress without the need for biopsies.
• Allowing precise delivery of various tumor-destroying approaches.

With sufficient resources in 2005, NCI will build on this momentum by:

• Expanding the discovery and development of novel imaging agents, devices, and methods.
• Accelerating the integration of advanced imaging methods into therapeutic clinical trials.
• Speeding the development and clinical testing of image-guided interventions (IGI).
• Stimulating research on components and systems integration of devices for in vivo molecular sensing.

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Areas of Public Health Emphasis

In each instance, we need better science to understand the complexities, and there is a pressing need to address the challenges posed to our Nation's healthcare system by the rising incidence of cancer in the aging U.S. population.

Research on Tobacco and Tobacco-Related Cancers. Tobacco use is the leading preventable cause of illness and death in the United States and is scientifically linked to an increasing number of cancers. Two obstacles that confront the research community in the fight against tobacco-related disease are particularly complex and drive the research agenda in this area: the addicting nature of tobacco products and the impact of tobacco advertising and marketing, especially on adolescents. In 2005, with sufficient resources:

• NCI will lead a vigorous research and public health effort consistent with the enormous burden of tobacco-related disease.
• We will support and develop innovative, integrated studies and interventions to understand, prevent, and treat tobacco use and addiction.
• We will work to deliver those interventions to aid in the prevention and treatment of tobacco use and tobacco-related cancers, and to inform public health policy.

Optimizing Energy Balance to Reduce the Cancer Burden. International teams of scientists have assembled compelling evidence that overweight and obesity, as well as low levels of physical activity, increase the risk of developing many cancers. At a time when almost two-thirds of the U.S. population is overweight or obese, NCI plans to invest additional resources into research on energy balance and carcinogenesis and into the development of related interventions for cancer prevention and control. Sufficient resources in 2005 will enable NCI to:

• Initiate new research to discover how body weight, physical activity, and diet, along with genetic and environmental factors, interact over a lifetime to influence the cancer process.
• Strive to improve cancer-related health outcomes by accelerating research on energy balance-related behaviors and by developing interventions across diverse populations.

Improving the Quality of Cancer Care. Far too few U.S. cancer patients receive the highest caliber of cancer care. At the same time, experts often differ substantially on what constitutes optimal care, especially from the patient's perspective, and on the best approaches for improvement. NCI plays a vital role in nationwide efforts to improve cancer care quality. With increased funding in 2005, we will:

• Further enhance quality-of-care research within and beyond the NCI clinical trials program.
• Work to incorporate symptom management and palliative care into the full spectrum of cancer quality improvement research and translation efforts.
• Sponsor collaborative projects to identify, develop, and monitor progress on core measures of cancer care quality and to translate research evidence into better quality care.
• Strengthen the methodological and empirical foundations of cancer care quality assessment as well as the measures that are used in those assessments.

Reducing Cancer-Related Health Disparities. The scientific community has a critical and unique role in addressing the moral and ethical dilemmas posed by the unequal burden of cancer in our society. We know that complex interactions among genetic susceptibilities and the risks imparted by individual and group behaviors, age, and social and environmental circumstances determine health throughout an individual's life span, including who becomes ill, who survives disease, and who maintains good quality of life after diagnosis and treatment. In 2005, NCI will use increased resources to:

• Work with other agencies in the Department of Health and Human Services (HHS) to implement recommendations from the Trans-HHS Cancer Health Disparities Progress Review Group, convened in 2003.
• Continue discovery efforts to more fully define the magnitude and causes of health disparities in cancer while emphasizing the translation of what we know today into the development and delivery of effective interventions to reduce cancer health disparities in all populations.

Improving Treatment Outcomes and Quality of Life for Cancer Survivors. Although cancer survivors are living longer, more productive lives than ever before, they are not yet free from the adverse effects of cancer diagnosis and treatment. NCI is working collaboratively with other groups to conduct the research that will help cancer survivors enjoy an improved quality of life. We plan to use increased resources in 2005 to:

• Discover the biological, physical, psychological, and social mechanisms, and their interactions, that affect a cancer patient's response to disease, treatment, and recovery.
• Accelerate the development of intervention research in these areas and collaborate with others to ensure the delivery of new information, interventions, and best practices to relevant audiences.
• Expand the development and use of tools to assess health-related quality of life and quality of care of post-treatment cancer survivors and their families.

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Platforms for Discovery, Development, and Delivery: Building Synergy through Interdisciplinary Team Science

Bringing the benefits of cancer research to the American people depends on building and sustaining the strong research mechanisms, support structures, and collaborations that make it possible for us to pursue rapidly evolving discoveries.

• Enhancing Investigator-Initiated Research
• Transforming the Capacity of Centers, Networks, and Consortia
• National Clinical Trials Program
• NCI's Intramural Research Program

Enhancing Investigator-Initiated Research. Investigator-initiated research has always been the primary means by which biomedical research is funded and conducted. These investigators ask the critical questions, explore the options, develop and test innovative technologies, and make the discoveries that lead to better cancer science and its application to patient care. With additional resources in 2005, we will be able to:

• Increase funding for, and the numbers of, competing research grants and provide incentives for transdisciplinary and collaborative research.
• Apply resources to encourage investigators to commit to careers in cancer research, to propose more innovative and higher-reward projects, and to conduct research in priority areas identified by advisory committees, NCI staff, and Progress Review Groups.

Transforming the Capacity of Centers, Networks, and Consortia. The interdisciplinary nature of today's cancer research requires new infrastructures that support team science and enable the sharing of a multitude of resources. The centers, networks, and consortia created and supported by NCI over the past 10 years comprise a model framework upon which to "grow" this evolving paradigm. In 2005, we will use increased resources to:

• Promote the strategic growth of NCI-supported Cancer Centers, incorporating and realigning resources to accelerate discovery, development, and delivery.
• Promote collaborations to improve access of minority populations to state-of-the-art clinical and population studies, cancer treatments, technologies, and care.
• Expand the capacity of NCI centers, networks, and consortia to engage in newly developing areas of research and technology and to act as platforms for translating discoveries into interventions.

National Clinical Trials Program. NCI-supported clinical trials provide a crucial infrastructure for moving new cancer interventions from the laboratory to studies in people with, or at risk for, cancer and then to the healthcare setting. We help researchers from public, industrial, and academic settings develop anti-cancer agents for a broader array of tumor types and at a faster pace than would otherwise be possible. While much has been accomplished to streamline cancer clinical trials, NCI must further accelerate movement of promising research discoveries into clinical development and delivery to the public. In 2005, NCI will use increased funding towards:

• Identifying and accelerating development of the most promising new agents for cancer treatment and prevention.
• Strengthening scientific planning and leadership for large clinical trials.
• Doubling the rate at which Phase III trials are completed.
• Ensuring that clinical trials are broadly accessible to cancer patients, populations at risk for cancer, and the physicians who care for these groups.

NCI's Intramural Research Program. NCI's Intramural Research Program (IRP) provides a unique venue for research innovation, translation, and application. The IRP serves as a proving ground for long-term, high-risk/high-impact projects. It complements our robust Extramural Research Program, which distributes about three-quarters of our research funding to research sites around the country. The following will strengthen the work of NCI's IRP and its unique contributions to helping us meet our Challenge Goal to eliminate suffering and death due to cancer:

• The opening of the new NIH Clinical Center facility in 2004
• The establishment of new consortia linking extramural and intramural investigators
• The development of new technologies
• New efforts to foster interdisciplinary approaches to scientific discovery

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Enablers of Discovery, Development, and Delivery: Strengthening Tools for Analysis, Resource Sharing, and Dissemination

Making these and other bioinformatics tools available to the research community for analysis and resource sharing is vital for enabling investigators to carry out state-of-the-art studies. Larger investments in cancer communications will enable the translation of successful intervention research into practice.

• Bioinformatics
• Cancer Communications

Bioinformatics. The exponential expansion of biomedical knowledge is generating a tidal wave of data. Contemporary bioinformatics tools must be harnessed to support cancer research and care, as well as effective dissemination of information to patients. NCI is positioned to provide the kind of informatics system and analytic tools needed to integrate diverse data types, capture and share research outcome data, and provide user-friendly tools that permit patients and their advocates to interact more directly with the cancer research community. With sufficient resources in 2005 we will establish a network of information technology partners and support the development of a shared infrastructure and tools that facilitate data mining and data integration.

Cancer Communications. Significant barriers impede the flow of effective cancer communications to patients and their caregivers, underserved populations, advocacy groups, health professionals, and the public health community. NCI strives to understand, apply, and disseminate effective communication approaches that maximize access to and appropriate use of cancer information by all who need it. In 2005, we will use funding in this area to:

• Increase knowledge about cancer information needs, beliefs, decisionmaking processes, and behaviors.
• Develop and evaluate communication resources and interventions for reducing the cancer burden, particularly among underserved populations.
• Engage with partners and the media to deliver evidence-based cancer interventions in clinical and public health programs.

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NCI's Budget Request for Fiscal Year 2005

(dollars in thousands)

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