How We Work

How NCI Funds Cancer Research

• Extramural Program
• Intramural Research
• AIDS Research
• Training and Education
• Other Research Support
• Links to Related Information

• Introduction
• Support for Extramural Research
• Cancer Centers
• Cancer Control

Research Project Grants (RPGs) (dollars in thousands)
	1999 Operating Budget	2000 President's Budget	2001 Core Budget
Ongoing	$983,129	$1,056,342	$1,166,993
New	377,516	353,517	366,244
Subtotal	1,360,645	1,409,859	1,5833,237
Small Business Innovation Research	57,808	60,978	63,173
TOTAL	$1,418,453	$1,470,837	$1,596,410

Research Project Grants
The main pool of funds expended by NCI for awards to extramural scientists is known as the Research Project Grant (RPG) pool. These funds foster the creativity of talented scientists by providing them with the freedom to pursue the best ideas that will yield progress against cancer.

NCI funds two main types of research project grants: Single Research Project Grants, awarded to institutions on behalf of individual principal investigators, and Program Project Grants, funded to foster collaborations among groups of scientists involved in related research projects. In FY 2000, NCI anticipates expending more than $1.4 billion in support of over 4,300 separate research grants. More than 1,150 of these awards will be new or competing renewal projects. The single investigator grant payline rose from the 15th percentile in FY 1995 to the 24th percentile in FY 1999. These grant awards and the dedicated researchers behind them constitute the largest single categorical investment of resources that NCI, through the extramural research community, makes annually to combat cancer. Collectively, the Single Research Project and Program Project Grants span the full range of basic, clinical, population-based, and translational studies of cancer etiology, biology, prevention, detection, diagnosis, treatment, control, and survivorship. The advances that come from these investments, such as the discovery and development of paclitaxel (Taxol®) and tamoxifen (Nolvadex®), and advances in the understanding of basic bone marrow transplant biology and clinical application, represent the future of cancer research and cancer care.

Other Grant Mechanisms
NCI also has special mechanisms for exceptionally high-risk, innovative, exploratory, and developmental research activities, to allow investigators to embark on projects of unusual scientific potential, and to support research and development ideas that are likely to result in the development of a commercial product or service.

Clinical Trials Infrastructure (dollars in thousands)
	1999 Operating Budget	2000 President's Budget	2001 Core Budget
TREATMENT:
Clinical Cooperative Research	$126,206	$125,460	$129,977
Community Clinical Oncology Program	6,565	6,007	6,009
Subtotal Treatment	132,770	131,467	135,985
PREVENTION:
Community Clinical Oncology Program	45,595	48,305	50,258
TOTAL	$178,366	$179,772	$186,244

Support for Extramural Clinical Research

Clinical research is one of the cornerstones of the National Cancer Program. Every new treatment we use today, every preventive measure that is widely recommended, and every innovative detection strategy was, at one time, tested in cancer patients or in people at risk for the disease. These heroes of the fight against cancer have allowed us to amass the body of information we are building upon every day. Even though trials often test the latest therapies, there is no guarantee of success – a person may be randomly assigned to a control group to receive standard therapy, or may participate in a Phase I or II trial which may be too early in the drug's development to know if it is effective. Nonetheless, trials provide patients and other participants access to cutting-edge interventions and provide researchers with information that ultimately will enable us to prevent and effectively treat all cancers.

A strong clinical research infrastructure, including a comprehensive program of clinical trials in treatment, early detection, and prevention, is a vital component of NCI's research program. NCI's Cancer Centers, Cooperative Groups, and Community Clinical Oncology Program are where findings from the laboratory are translated into new treatments, diagnostic tools, and preventive interventions, and where these measures are first tested for safety and effectiveness. These programs are fundamentally interrelated: every Cancer Center is a participant in at least one Cooperative Group, and Cooperative Groups serve as research bases for participants in the Community Clinical Oncology Program. Hundreds of clinical trials are supported through these and other research mechanisms, such as Single Research Project Grants, Program Project Grants, cooperative agreements, and contracts.

NCI's programs in clinical research have enjoyed many notable successes over the years. NCI has been responsible for the early development and/or testing of many important treatments, including paclitaxel (Taxol®) for breast and ovarian cancer, interferon alpha-2b for malignant melanoma, and Herceptin® for breast cancer. Studies to test the effectiveness of certain drugs to prevent first occurrences of cancer include the ongoing Prostate Cancer Prevention Trial. The Breast Cancer Prevention Trial demonstrated a 49 percent reduction in breast cancer incidence during the treatment period among high-risk participants who took the drug tamoxifen (Nolvadex®). Based on the results from that trial, the Food and Drug Administration has approved the use of tamoxifen to reduce the chance that women at high risk of breast cancer will develop the disease.

Through our clinical research programs, we also have identified successful interventions for symptom management and continuing care of cancer patients, including treatment for mouth sores and hot flashes, both common side effects of chemotherapy. And based on the results of laboratory research, we now are exploring interventions for individuals whose genetic profile places them at increased risk of cancer.

However, our ability to conduct clinical trials is in danger of being compromised by changes in the health care system. In the past, institutions have used surplus revenues from patient care services to supplement government research support. The growth of managed care has all but eliminated those discretionary funds. As a result, institutions can no longer sponsor research activities requiring capital expenditures and cannot support essential training for young investigators. These changes pose a very real danger for the continuation of cancer research and our continued progress against cancer.

In response to the changing health care system, we are developing ways to improve access to and participation in clinical trials. To ensure that physicians have the time to conduct clinical trials, we have developed a Midcareer Investigator Award in Patient-Oriented Research that offers subsidies to clinicians, allowing them protected time to devote to vital patient-oriented research. Further, through agreements with private insurers and other government agencies, we are working to assure insurance coverage for individuals participating in trials. We have two government interagency agreements, one with the Department of Defense (DoD) that provides coverage for DoD health plan beneficiaries to participate in NCI-sponsored cancer treatment trials, and a second with the Veteran's Administration that covers the full range of NCI-sponsored clinical trials. This year, we signed a new agreement with the DoD, marking the first time a health plan has agreed to provide coverage for participation in cancer prevention trials. Based on these initial successes, several organizations have enacted agreements at the local, state, and national levels to provide greater access and coverage for clinical trials. For example, in 1999 the United Health Care Corporation began piloting a program providing coverage of the patient care costs associated with cancer treatment trials conducted by the NCI-supported Coalition of Cooperative Groups. Several states also have enacted legislation designed to provide greater access and coverage for clinical trials. In addition, NCI is working with patient advocates, local communities, and non-profit organizations to increase awareness of and education about clinical trials. Together with other clinical trials efforts, we hope these initiatives will serve as national models and provide access for more individuals interested in participating in clinical trials.

Cooperative Group Clinical Trials Program
The sheer number of different types of cancer and their biological complexity make the process of efficiently identifying and evaluating new treatments or other anti-cancer strategies extremely challenging. To test potential treatment advances in patients more rapidly, NCI maintains the Cooperative Group program, a national network of 12 consortia (Cooperative Groups) that seek to define the key unanswered questions in cancer and then conduct clinical trials to answer them. Each year, 1,700 institutions throughout the United States and Canada, and approximately 8,000 investigators in these institutions participate in these trials. This kind of cooperation makes it possible to centralize administration and data collection for trials taking place at a large number of sites around the world. The Cooperative Groups differ in structure and research organization, but they share the common purpose of developing and conducting large-scale trials in multi-institutional settings.

Cooperative Groups frequently work together when the cancer in question is so rare that one group working alone would be unable to accrue enough patients to conduct a meaningful study. For example, six Cooperative Groups worked together on the landmark study establishing that all-trans retinoic acid (ATRA) significantly improves disease-free survival time for patients with acute promyelocytic leukemia. Cooperative Groups collaborate regularly on clinical trials for solid tumors in children, breast cancer, colorectal cancer, lung cancer, prostate cancer, and cancers of the head and neck.

Approximately 20,000 patients participate in Cooperative Group clinical trials each year, principally in large Phase III trials that help establish the state of the art for cancer therapy. Many new anti-cancer drugs are tested in patients for the first time under NCI Investigational New Drug (IND) sponsorships through the Cooperative Group program. Nearly 200 investigational agents or treatment strategies, ranging from new chemotherapy drugs and cancer vaccines to agents that prevent tumor blood vessel development, are currently being studied under NCI INDs.

An agreement between the U.S. Office for Protection from Research Risks and the European Organization for Research and Treatment of Cancer (EORTC) promises to improve the ability of NCI's Cooperative Groups to collaborate with the EORTC and other international cancer research groups.

Community Clinical Oncology Program (CCOP)
The Community Clinical Oncology Program is a network of 49 central offices in 31 states that provides the infrastructure to link more than 2,500 community cancer specialists and primary care physicians with clinical Cooperative Groups and Cancer Centers. In addition, CCOPs support scientific development and the implementation of ongoing cancer treatment, prevention, and control clinical trials among community Cooperative Group members and Cancer Centers.

This network enables individuals to participate in state-of-the-art clinical research trials at over 340 community hospitals without the burden of traveling to a distant site. Each year, the Program enrolls more than 5,000 patients in cancer treatment clinical trials and an additional 3,500 patients in cancer prevention and control clinical trials. An additional seven Minority-based CCOPs increase the participation of minority individuals in clinical trials research. Each year, over 700 patients enter clinical trials through these specialized CCOPs. Located in six states and Puerto Rico, these programs bring an additional 33 hospitals and 250 physicians into the clinical trials network. By increasing the number of patients and physicians who participate in clinical trials, the program helps transfer the latest research findings to the community.

Cancer Centers (dollars in thousands)
	1999 Operating Budget	2000 President's Budget	2001 Core Budget
Basic	$13,504	$18,765	$19,441
Clinical/ Comprehensive	134,738	137,014	141,947
Subtotal Core Grants	148,242	155,779	161,387
Planning	1,131	787	815
SPOREs (P50)	48,117	40,889	42,361
TOTAL	$197,490	$197,455	$204,563

Cancer Centers
Fifty-nine research-oriented institutions throughout the Nation have been designated NCI-supported Cancer Centers in recognition of their scientific excellence. The Centers are key partners in NCI's efforts to speed the process of discovery and bring the benefits of cancer research directly to the public. Located throughout the country, each Cancer Center is a hub of cutting-edge research, high quality cancer care, and outreach and education for both health care professionals and the general public.

When an institution meets the rigorous competitive standards to become an NCI Cancer Center, it is awarded a Cancer Center Support Grant. These funds enable the institution to coordinate multidisciplinary approaches to research questions, to gain access to the most advanced research technologies, and to take rapid advantage of new research opportunities. Support for the Cancer Centers helps ensure a close association between state-of-the-art research and state-of-the-art care activities within the institution. Moreover, it allows each Center to develop key collaborations with industrial, community, and state health organizations, and to link the research capabilities and expertise of scientists within the institution to problems of cancer incidence and mortality in their communities and regions.

Three types of centers exist: Cancer Centers have specific research foci, such as epidemiologic or basic research; Clinical Cancer Centers integrate basic science with clinical science; and Comprehensive Cancer Centers demonstrate both significant scientific strength in basic, clinical, and population studies and strong interdisciplinary collaboration. Comprehensive Cancer Centers also must have in place effective cancer information, education, and outreach activities for the regions and communities they serve.

Traditionally, Cancer Centers have had broad scientific bases, and most have been developed within a single institution. Changes in the program, however, are enabling the planning of new consortia of institutions, often linking free-standing clinical and academic centers with community hospitals to form networks with tremendous research strength and the ability to deliver quality care in a managed care environment. In addition, more focused scientific concepts are being developed for Cancer Centers. For example, some Centers are focusing on population sciences and others are concentrating on translational research opportunities within a specific scientific discipline, such as immunology. Overall, such changes in the Cancer Centers program promise to increase the scientific versatility, translational research capabilities, and geographic distribution of NCI-supported Cancer Centers.

Cancer Control (dollars in thousands)
	1999 Operating Budget	2000 President's Budget	2001 Core Budget
Grants	$107,549	$113,671	$127,734
Contracts	103,828	116,408	120,599
Cancer Control Management & Support	89,882	82,640	85,946
TOTAL	$301,259	$312,719	$334,278

Cancer Control

Cancer control research encompasses basic and applied research in the behavioral, social, and population sciences aimed at creating or enhancing interventions that, by themselves or in combination with biomedical approaches, reduce cancer risk, incidence, morbidity, and mortality, and improve quality of life. For example, a cancer control study might investigate the use of a medical intervention, such as a nicotine patch, in combination with a behavioral intervention, such as a counseling program to help smokers overcome their barriers to quitting. Interventions may be directed at patients, physicians, and/or other health care providers. Cancer control research seeks to improve interventions across the human lifespan and over the entire cancer continuum, and to move research findings into clinical and public health practice. The foundation of cancer control research is epidemiology, and surveillance and outcomes research are the fundamental mechanisms for assessing progress.

NCI maintains a firm commitment to cancer control research through the Division of Cancer Control and Population Sciences (DCCPS), the focus for NCI-sponsored research programs aimed at studies in populations, behavior, surveillance, special populations, outcomes, and other aspects of cancer control. Our wide-ranging cancer control research efforts include research in epidemiology and genetics, tobacco research, tailored communications, and theoretical models for studies of human behavior and behavior change.

Cancer surveillance – tracking and analyzing trends in cancer incidence, mortality, and survival rates – is a critical component of cancer control. The keystone of NCI's surveillance efforts is the Surveillance, Epidemiology, and End Results (SEER) program, which monitors the Nation's cancer burden and provides the basis for assessing individual, organizational, and societal factors that can reduce cancer rates.

Intramural Research (dollars in thousands)
	1999 Operating Budget	2000 President's Budget	2001 Core Budget
Basic	$173,218	$172,602	$179,506
Clinical	117,039	116,623	121,288
Epidemiology & Genetics	48,987	48,823	51,156
NIH Central Services	149,640	149,097	154,681
TOTAL	$488,884	$487,144	$506,630

Intramural Research

The NCI Intramural Research Program (IRP), consisting of more than 400 principal investigators in the Divisions of Basic Sciences, Cancer Epidemiology and Genetics, and Clinical Sciences, is dedicated to the comprehensive understanding of cancer and to finding cures for these diseases. Organized to complement ongoing research in universities and in industry, the IRP has been involved in pivotal discoveries in cancer research: the first successful treatments for childhood leukemias; establishing the principles for curative chemotherapy for lymphomas; developing effective therapies for HIV; defining the foundations for tumor vaccines; identifying the genetic causes for familial cancers; and uncovering environmental causes of cancer.

The IRP's epidemiology research program is a national program of population-based studies to identify environmental and genetic determinants of cancer. This IRP component supports epidemiologic and interdisciplinary research to ensure that the momentum of recent and ongoing discoveries in molecular genetics and cancer biology is accelerated and broadened through population-based studies into the etiology of cancer and its prevention.

The intramural clinical research program is conducted principally in NIH's Warren G. Magnuson Clinical Center. It provides the opportunity for patients from across the country to be treated through ground-breaking research protocols. The Clinical Center is a unique environment in which investigators throughout the NIH community develop and test novel therapies derived from our growing body of knowledge; in this environment new information can be transferred quickly from the laboratory to the patient and back to the laboratory for additional analysis.

The Intramural Research Program is uniquely structured to address cancer research problems whose resolution requires long-term commitments and that may be considered unsuitable for many extramural funding mechanisms. Another unique aspect of the Intramural Program is its framework for cooperation between basic researchers and investigators performing clinical trials. These interactions, fostered by common research interests, topic-specific focus groups and retreats, and close physical proximity of basic and clinical research efforts, result in rapid translation of new basic research discoveries into early clinical trials.

Because of its national stature and unique structure, NCI's IRP also is a center for basic, clinical, and population-based oncology training for researchers, clinicians, research fellows, and visiting scholars from around the world. NCI plays a major role in fostering the education and careers of a growing number of nurses, doctors, and physician assistants, as evidenced by the approximately 500 participants each year in the summer intramural research training program. Many of the current leaders in cancer research received some of their training at NCI, and we anticipate that the IRP will continue to be an important resource for training the next generation of investigators.

Learn more about:

• NCI's Intramural Program

AIDS Research

Malignancies occur in more than 30 percent of AIDS cases and contribute greatly to AIDS morbidity and mortality. Many areas of fundamental biology developed in NCI programs, including virology, immunology, and cellular and molecular biology, are directly applicable to understanding HIV and AIDS. Research efforts in AIDS malignancies begins with basic science that provides new insights in cancer biology that can lead to hypotheses to test in epidemiologic studies, the development of treatment targets, and new treatments to prevent and control AIDS malignancies. But basic science, even with associated drug development programs, would not make progress without clinical programs in which to test potential discoveries. Work in this area is necessarily collaborative and one of NCI's major roles is to foster these collaborations, create research groups, and provide infrastructure, including clinical trials support, central specimen banking, international scientific meetings, and new investigator training.

Today, research into the fundamental biology of HIV and AIDS, AIDS treatment, and particularly AIDS-related malignancies takes place throughout all programmatic mechanisms of NCI. The Intramural Research Program is an internationally recognized center for research in HIV and AIDS, housing the HIV Drug Resistance Program, the HIV and Malignancies Branch, and the NIH Vaccine Research Center, a joint project with the National Institute of Allergy and Infectious Diseases. The Extramural Research Program also has been a vital and innovative force in this area of research. Among its programs are the AIDS Malignancy Consortium, the AIDS Malignancy Bank, the AIDS Oncology Clinical Scientist Training Program, and an annual international forum on AIDS malignancies.

NCI, in coordination with other NIH Institutes and the NIH Office of AIDS Research, continues its commitment to meeting the challenge of AIDS and is working to ensure that NCI-supported AIDS and AIDS-related research is integrated with national AIDS strategies.

Training and Education (dollars in thousands)
	1999 Operating Budget	2000 President's Budget	2001 Core Budget
National Research Service Awards	$57,135	$58,026	$60,115
Research Career Program	34,881	38,915	40,316
Cancer Education Program	17,319	16,692	17,293
Minority Biomedical Research Support	2,788	3,623	4,373
TOTAL	$112,123	$117,256	$122,097

Training and Education

In the past decade, we have made stunning advances in our understanding of cancer. Our ability to bring these new discoveries to the communities and clinics where they benefit cancer patients and those at risk for developing cancer depends on physicians and other scientists who are specially trained in cancer research. While resources for training are shrinking at many institutions, NCI is committed to ensuring that a national cadre of trained cancer researchers exists by continuing to provide essential training to our Nation's scientific and medical workforce.

To address this crucial requirement, NCI has developed a strategic plan for extramural training, education, and career development. This plan focuses on attracting young scientists into cancer research, on providing stability and protected research time for researchers in disciplines critical to translational research, on creating more opportunities for underserved ethnic and minority scientists, and on encouraging research program diversification. In pursuit of these objectives, NCI has implemented a number of new training and career development programs in basic, clinical, population, and diversified sciences, as well as for underserved ethnic and minority groups who are underrepresented in the research workforce. These programs aid investigators in stabilizing and sustaining productive research careers, and offer opportunities for engaging in translational research.

NCI's research divisions also are developing training programs. For example, the Division of Clinical Sciences' Clinical Intramural Research Award supports innovative and collaborative clinical research projects emphasizing novel approaches or promising new outcomes of current research; the Division of Cancer Epidemiology and Genetics' Cancer Genetics and Epidemiology Fellowship Program provides interdisciplinary training in clinical, molecular, and quantitative genetics, and genetic epidemiology; and the Division of Cancer Prevention Fellowship provides training in cancer prevention and control for individuals from many health science disciplines.

Other Research Support (dollars in thousands)
	1999 Operating Budget	2000 President's Budget	2001 Core Budget
Research Support Contracts	$275,087	$298,569	$309,519
Scientific Evaluation Grants	3,528	3,742	3,877
Research Resource Grants	19,437	21,388	22,106
Construction	3,000	3,000	5,000
Conference Grants	901	1,101	1,141
Research Management & Grants	108,965	110,065	114,468
TOTAL	$410,918	$437,815	$456,111

Other Research Support

In addition to its many types of grants and awards, NCI employs a variety of other research support mechanisms. These mechanisms include: contracts to provide support for research, information dissemination, and management; conference grants to fund meetings, conferences, and workshops; resource-related research projects to improve the ability of resources to serve biomedical research; scientific evaluation awards to support the scientific review of grant and contract proposals; and construction grants and contracts to provide partial support for the modernization or development of cancer research facilities throughout the Nation.

NCI also sustains, guides, and monitors both the extramural and intramural activities of the Institute through its research management and support activities. These activities include overall scientific program direction and administration by the Office of the Director, with assistance from grant and contract science managers, finance, human resources, legislation, science program direction and assessment, and technology transfer staff. The review and oversight activities of the National Cancer Advisory Board and President's Cancer Panel also are included. This part of the budget also supports a share of central NIH facilities and operations, and extramural program staff salaries (intramural staff salaries and intramural facilities maintenance are included under the intramural research budget).

Links to Related Information