The Unequal Burden of Cancer An Assessment of NIH Research and Programs for Ethnic Minorities and the Medically Underserved M. Alfred Haynes and Brian D. Smedley, Editors Committee on Cancer Research Among Minorities and the Medically Underserved Health Sciences Policy Program Health Sciences Section INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C. 1999 Notice Committee Reviewers Preface Contents Executive Summary NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. Support for this project was provided by funds from the National Institutes of Health (Contract No. N01-OD-4-2139). The views presented in this report are those of the Committee on Cancer Research Among Minorities and the Medically Underserved and are not necessarily those of the funding organization. Library of Congress Cataloging-in-Publication Data The unequal burden of cancer : an assessment of NIH research and programs for ethnic minorities and the medically underserved / M. Alfred Haynes and Brian D. Smedley, editors ; Committee on Cancer Research among Minorities and the Medically Underserved, Health Sciences Policy Program, Health Sciences Section, Institute of Medicine.            p. cm.      Includes bibliographical references (p. ) and index.      ISBN 0-309-07154-2 (hard)      1. CancerResearch--Government policy--United States. 2. Minorities--Diseases--Research--Government policy--United States. 3. Poor--Diseases--Research--Government policy--United States. 4. National Institutes of Health (U.S.) I. Haynes, M. Alfred. II. Smedley, Brian D. III. Institute of Medicine (U.S.) Committee on Cancer Research among Minorities and the Medically Underserved.      RC267 .A77 1999      362.1'96994'008900973dc21                              99-6105 The Unequal Burden of Cancer: An Assessment of NIH Research and Programs for Ethnic Minorities and the Medically Underserved is available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Lock Box 285, Washington, DC 20055. Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit the NAP's on-line bookstore at: www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at www2.nas.edu/iom. Copyright 1999 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. COMMITTEE ON CANCER RESEARCH AMONG MINORITIES AND THE MEDICALLY UNDERSERVED M. ALFRED HAYNES (Chair), Former President and Dean, Drew Postgraduate Medical School, and Former Director, Drew-Meharry-Morehouse Consortium Cancer Center, Rancho Palos Verdes, California REGINA BENJAMIN, Physician, Bayou La Batre Rural Health Clinic, Inc., Bayou La Batre, Alabama CHARLES L. BENNETT, Director of Outcomes Research, Robert Lurie Cancer Center, Northwestern University, and VA Chicago Health Care Systems BARUCH S. BLUMBERG, Fox Chase Distinguished Scientist, Fox Chase Cancer Center, Philadelphia MOON S. CHEN, JR., Professor and Chair, Division of Health Behavior and Health Promotion, School of Public Health, College of Medicine and Public Health, Ohio State University GILBERT FRIEDELL, Director for Cancer Control, University of Kentucky ANNA R. GIULIANO, Assistant Professor of Epidemiology, Arizona Prevention Center, Director, Minority Cancer Prevention and Control Program, Arizona Cancer Center, University of Arizona JAMES W. HAMPTON, Medical Director, Troy and Dollie Smith Cancer Center at Integris Baptist Medical Center, Clinical Professor of Medicine, University of Oklahoma College of Medicine, and Cancer Care Associates, Oklahoma City VICTOR A. McKUSICK (Vice Chair) University Professor of Medical Genetics, Johns Hopkins Hospital, Johns Hopkins University School of Medicine LAWRENCE MIIKE, Director, Department of Health, State of Hawaii, Honolulu SARAH MOODY-THOMAS, Associate Director, Stanley S. Scott Cancer Center, and Professor, Department of Psychiatry, Louisiana State University Medical Center, New Orleans LARRY NORTON, Associate Professor of Oncology, Mount Sinai School of Medicine, and Head, Breast Disease Management Team, Memorial Sloan-Kettering Cancer Center, New York MADISON POWERS, Senior Research Scholar, Kennedy Institute of Ethics, Georgetown University SUSAN C. SCRIMSHAW, Dean, School of Public Health, and Professor, Community Health Sciences and Anthropology, University of Illinois at Chicago FERNANDO M. TREVINO, Professor and Chairman, Department of Public Health and Preventive Medicine, Health Science Center at Forth Worth, University of North Texas Committee Liaisons ADA SUE HINSHAW, Dean, School of Nursing, University of Michigan AMELIE G. RAMIREZ, Associate Professor and Associate Director, Center for Cancer Control Research, Baylor College of Medicine Study Staff BRIAN SMEDLEY, Study Director YVETTE BENJAMIN, Research Associate (through 10/98) THELMA COX, Senior Project Assistant Consultant TED CRON Copy Editors MICHAEL EDINGTON MICHAEL HAYES Section Staff CHARLES H. EVANS, JR., Head, Health Sciences Section ANDREW M. POPE, Director, Health Policy Program LINDA DEPUGH, Administrative Assistant JAMAINE TINKER, Financial Associate (through 10/98) Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making the published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their participation in the review of this report: Mary Ellen Avery, M.D., Harvard Medical School; Lester Breslow, M.D., M.P.H., University of California at Los Angeles School of Public Health; H. Jack Geiger, M.D., City University of New York Medical School; Reginald C. S. Ho, M.D., Straub Clinic and Hospital, Honolulu, Hawaii; Frederick P. Li, M.D., Harvard Medical School; Sandra Millon-Underwood, Ph.D., R.N., University of Wisconsin School of Nursing; Geraldine Padilla, Ph.D., Jonsson Comprehensive Cancer Center, University of California at Los Angeles; Frank Talamantes, Ph.D., Sinsheimer Laboratories, University of California at Santa Cruz; and Richard Warnecke, Ph.D., School of Public Health and College of Urban Planning and Public Administration, University of Illinois at Chicago. While the individuals listed above have provided constructive comments and suggestions, it must be emphasized that responsibility for the final content of this report rests entirely with the authoring committee and the institution. Preface In 1971, President Richard M. Nixon signed the National Cancer Act and assigned the leadership for the "War on Cancer" to the National Cancer Institute (NCI). Since that time, NCI has vigorously supported research that has broadened our understanding of the mechanisms of carcinogenesis and has led the way to advances in prevention, control, and treatment of a disease for which there is increasing demand for a "cure." Congress, and the public at large, are deeply indebted to NCI for its outstanding research leadership, and the results of those efforts are beginning to be more widely recognized. However, Congress has from time to time requested assurance that all segments of the population are benefiting from the results of this research, in accordance with the mission of the National Institutes of Health (NIH) to conduct research to improve the health of all Americans. This study was prompted by a concern for ethnic minority and medically underserved populations that often experience a greater burden of cancer. The committee began its work in late January 1998, and completed its report in the fall of that year. In the process, we received presentations from the director of NCI and several members in leadership positions within the institute. The committee also reviewed numerous documents from NCI and other NIH institutes. To better understand how NIH's work has been received by important constituencies, the committee also conducted a survey of researchers involved in relevant research and heard from a number of community organizations with specific interests in cancer among these populations. Our findings and recommendations are provided in this report, which is organized as follows: a brief history of the nation's struggle against cancer (Chapter 1); information on the burden of cancer among ethnic minorities and the medically underserved, and recommendations addressing the quality and scope of the data on which cancer research for these populations is based (Chapter 2); a review of research and training programs and activities on ethnic minorities and medically underserved populations at NIH and recommendations on how these programs and activities could be improved (Chapters 3 through 6); and, an annual reporting mechanism on the status of cancer research among ethnic minorities and the medically underserved at NIH, and recommendations on what these reports should contain (Chapter 7). The committee was impressed by the momentum around these issues at NCI. In fact, some of the recommendations were already in the process of being implemented before the report was completed. The committee has felt free to make its recommendations always with the best interests of the populations concerned in mind and with the hope that the already excellent leadership provided by NCI will become even better. The committee deeply appreciates the cooperation received from NCI and the other institutes at NIH in providing information we requested, and then subsequently providing still more information as the first set led to further requests. These efforts were graciously coordinated by Dr. Otis Brawley of NCI. Dr. Delores Parron of the National Institute of Mental Health served as the study's project officer and was instrumental in facilitating the project's timely completion. The committee is also grateful to the National Center for Health Statistics for documenting the methodology and caveats of an alternative method for assessing progress by considering the potential reduction of cancer deaths if the best rate among all ethnic groups were used as a reference. Finally, we were fortunate to receive the active input and contributions of Dr. Amelie Ramirez, a member of the Institute of Medicine and National Research Council's National Cancer Policy Board. The work of the committee was a pleasure because of the enthusiasm and commitment of its members, greatly facilitated by an outstanding project director and a dedicated staff. All that is now necessary to complete our feeling of satisfaction is for the recommendations to continue to be implemented in a timely fashion so that all ethnic groups of our one race, the human race, are able to benefit from a reduction in what promises to be the leading cause of death in the twenty-first century. M. Alfred Haynes, M.D. Chair Contents EXECUTIVE SUMMARY 1 1   THE STRUGGLE AGAINST CANCER 16   The Focus on Cancer 17   Progress Reports 25   Finally, Some Good News 28   The Healthy People 2000 Review 29   More Good News 30   The Fundamental Questions 30 2   THE BURDEN OF CANCER AMONG ETHNIC MINORITIES AND MEDICALLY UNDERSERVED POPULATIONS 33   Defining the Populations 33   The Burden of Cancer Among Ethnic Minorities and Medically Underserved Populations 45   Future Directions in Assessing the Burden of Cancer Among Ethnic Minority and Medically Underserved Groups 76   Summary 91 3   OVERVIEW OF PROGRAMS OF RESEARCH ON ETHNIC MINORITY AND MEDICALLY UNDERSERVED POPULATIONS AT THE NATIONAL INSTITUTES OF HEALTH 93   Overview of NIH Appropriations and Funding for Cancer Research 94   Cancer Research at Other ICDs 96   Office of Research on Minority Health 97   Overview of Scientific Infrastructure at NCI 104   NCI FY 1997 Program and Resources Allocated to Addressing Ethnic Minority and Medically Underserved Populations 107   Allocation of NCI Resources for Research on Ethnic Minority and Medically Underserved Groups 138   Research on Cancer Among Ethnic Minority and Medically Underserved Populations at Other ICDs 141   Summary and Recommendations 150 4   EVALUATION OF PRIORITY SETTING AND PROGRAMS OF RESEARCH ON ETHNIC MINORITY AND MEDICALLY UNDERSERVED POPULATIONS AT THE NATIONAL INSTITUTES OF HEALTH 154   Survey of Research Stakeholders 155   What Are the Needs of Cancer Survivors in Ethnic Minority and Medically Underserved Communities? 162   Mechanisms for Ethnic Minority Community and Researcher Input into the Cancer Agenda 169   Special Populations and Priority Setting at NCI 174   Summary 185 5   ADVANCING STATE-OF-THE-ART TREATMENT AND PREVENTION 187   Recruitment and Retention of Ethnic Minority and Medically Underserved Participants in Clinical Cancer Research 188   Ethnic Minority Accrual in NIH-Sponsored Trials 193   How Can Low Ethnic Minority Accrual Be Addressed? 210   Dissemination of Research Findings to Ethnic Minority and Medically Underserved Communities 214   Recommendations 226   Summary 228 6   CANCER SURVIVORSHIP 230   Review of Related Literature 231   NIH and NCI Programs and Research Outcomes Relevant to Cancer Survivorship 234   Needs of Ethnic Minority and Medically Underserved Cancer Survivors 239   Recommendations 242 7   MONITORING AND REPORTING 246   Reporting of Results 248   Special Process Items 257   Types and Timing of Reports 258   Summary 259 REFERENCES 261 APPENDIXES   A   Methodology 277   B   A New Agenda for Cancer Control Research: Report of the Cancer Control Review Group 282   C   National Cancer Institute Health Promotion Branch Publications and Public Service Announcements 283   D   Survey of Ethnic Minority Researchers and of Researchers Interested in Cancer Among Ethnic Minority and Medically Underserved Groups 285   E   National Institutes of Health and National Cancer Institute Background Material 293   F   Information Provided by the National Center for Health Statistics on the Potential Reductions in Mortality from Cancer, by Ethnic Group 295 COMMITTEE AND STAFF BIOGRAPHIES 315 INDEX 323 Executive Summary Cancer is second only to cardiovascular disease as the leading cause of death among Americans. One in four deaths in the United States is attributable to cancer, and one in three Americans will eventually develop some form of cancer. Furthermore, it is expected to be the leading cause of death in the United States in the next century (National Cancer Institute, 1998a). With the expansion of federal research efforts, however, the scientific understanding of cancer control, prevention, detection, and treatment has improved significantly, leading recently to the first overall decline in the cancer mortality rate in the United States in decades (Wingo et al., 1998). Despite scientific gains, not all segments of the U.S. population have benefited to the fullest extent from advances in the understanding of cancer. Although many ethnic minority groups experience significantly lower levels of some types of cancer than the majority of the U.S. white population, other ethnic minorities experience higher cancer incidence and mortality rates. African-American males, for example, develop cancer 15 percent more frequently than white males (Miller et al., 1996). The rate of breast cancer among African-American women is not as high as that among white women, but the former group are more likely to die from the disease once it is detected (Bacquet and Ringen, 1986). Similarly, some specific forms of cancer affect other ethnic minority communities at rates up to several times higher than national averages (e.g., stomach and liver cancers among Asian-American populations, colon and rectal cancer among Alaska Natives, and cervical cancer among Hispanic and Vietnamese-American women [Miller et al., 1996]). Many ethnic minorities also experience poorer cancer survival rates than whites. American Indians, for example, experience the lowest cancer survival rates of any U.S. ethnic group (Gilliland et al., 1998). In addition, individuals of all ethnic backgrounds who are poor, lack health insurance, or otherwise have inadequate access to high-quality cancer care typically experience high cancer incidence and mortality rates and low rates of survival from cancer (American Cancer Society, 1990). Many low-income white populations have cancer diagnosis rates as high as or higher than those for ethnic minority groups most affected by the disease. In Appalachian Kentucky, for example, a region characterized by high rates of poverty, the incidence of lung cancer among white males was 127 per 100,000 in 1992, a rate higher than that for any ethnic minority group in the United States during the same period (Gilbert Friedell, Director of the Kentucky Cancer Registry, personal communication, August 8, 1998). These disparities in the burden of cancer prompted the U.S. Congress in 1997 (P.L. 104-208) to request a review of the programs of research at the National Institutes of Health (NIH) relevant to ethnic minority and medically underserved populations. An Institute of Medicine (IOM) committee was impaneled in 1998 and was charged with the following: reviewing the status of cancer research relative to minorities and medically underserved populations at the various Institutes, Centers, and Divisions of NIH to evaluate the relative share of resources allocated to cancer in minorities (including a review of NIH's ability to prioritize its cancer research agenda for minorities and medically underserved groups and the role of minority scientists in decision making on research priorities); examining how well research results are communicated and applied to cancer prevention and treatment programs for minorities and medically underserved populations, and the adequacy of understanding of survivorship issues that uniquely affect minority and underserved communities; and, examining the adequacy of NIH procedures for equitable recruitment and retention of minorities in clinical trials. The committee was also asked to make recommendations on an annual reporting mechanism on the status of cancer research at NIH among minority and medically underserved populations. NIH, as the nation's leading federal agency supporting research to improve the nation's health, and the National Cancer Institute (NCI), as the principal unit of NIH charged with conducting cancer research and information dissemination services, served as the focal points of the committee's inquiry, along with other institutes and centers (ICs) of NIH that collaborate with NCI on cancer-related research. Although NCI holds the lead role in the development and implementation of the National Cancer Program, other federal agencies, such as the Centers for Disease Control and Prevention (CDC), the U.S. Department of Veterans Affairs (VA), the U.S. Department of Defense, and others perform related cancer prevention, control, and information collection and dissemination services, and therefore share responsibility with NIH for making improvements in the nation's health. The work of these other agencies lies outside of the purview of this committee, but they are critical components of the National Cancer Program and need to be incorporated into the National Cancer Plan. FINDINGS AND RECOMMENDATIONS To address the study charge, the committee reviewed extensive information provided by NIH and NCI staff, and received input from outside of NIH via a panel of community representatives and a survey of researchers interested in cancer among ethnic minority and medically underserved populations. The committee's recommendations are listed in Box 1. BOX 1 Committee Recommendations Chapter 2: The Burden of Cancer Among Ethnic Minorities and Medically Underserved Populations Recommendation 2-1: NIH should develop and implement across all institutes a uniform definition of "special populations" with cancer. This definition should be flexible but should be based on disproportionate or insufficiently studied burdens of cancer, as measured by cancer incidence, morbidity, mortality, and survival statistics. Recommendation 2-2a: To further enhance the excellent data provided in the Surveillance, Epidemiology, and End Results (SEER) program database, adequate resources should be provided to expand SEER program coverage beyond the existing sites to include high-risk populations for which SEER program coverage is lacking. This expansion should address a wider range of demographic and social characteristics by using consistent nomenclature and a uniform data set and by reflecting the diverse characteristics of the current U.S. population. Recommendation 2-2b: NCI should continue to work with the North American Association of Central Cancer Registries and other organizations to expand the coverage and enhance the quality of the 45 non-SEER program state cancer registries, with the intent of ultimately achievingtogether with the SEER program state registriestwo goals: (1) a truly national data set obtained through a system of longitudinal population-based cancer registries covering the entire country, and (2) a reliable database for each state to serve as the basis for both the development and the evaluation of cancer control efforts in that state. Recommendation 2-3: Annual reporting of cancer surveillance data and population-based research needs to be expanded to include survival data for all ethnic groups, as well as for medically underserved populations. Recommendation 2-4: The committee recommends an emphasis on ethnic groups rather than on race in NIH's cancer surveillance and other population research. This implies a conceptual shift away from the emphasis on fundamental biological differences among "racial" groups to an appreciation of the range of cultural and behavioral attitudes, beliefs, lifestyle patterns, diet, environmental living conditions, and other factors that may affect cancer risk. Recommendation 2-5: The committee commends the proposed NCI program of expanded behavioral and epidemiologic research examining the relationship between cancer and cancer risk factors associated with various ethnic minority and medically underserved groups and recommends that these studies be conducted both across and within these groups. Chapter 3: Overview of Programs of Research on Ethnic Minority and Medically Underserved Populations at the National Institutes of Health Recommendation 3-1: The Office of Research on Minority Health should more actively serve a coordinating, planning, and facilitative function regarding research relevant to cancer among ethnic minority and medically underserved populations across relevant institutes and centers of NIH. To further this goal, the Office of Research on Minority Health should make criteria for Minority Health Initiative project support explicit; coordinate with other specialty offices (e.g., the Office of Research on Women's Health) by participating in NIH-wide coordination efforts such as the Research Enhancement Awards Program; and ensure that Minority Health Initiative funding does not supplant funding from institutes and centers for research and programs relevant to ethnic minority and medically underserved populations. Recommendation 3-2: Research and research funding relevant to cancer among ethnic minority and medically underserved populations should be more adequately assessed (as per Recommendation 3-3) and should be increased. Recommendation 3-3: NIH should improve the accuracy of its assessment of research that is relevant to ethnic minority and medically underserved groups by replacing the current "percent relevancy" accounting method with one that identifies studies whose purpose is to address a priori research questions uniquely affecting ethnic minority and medically underserved groups. Recommendation 3-4: The newly established program of behavioral and social science research at NCI addresses an area of research that has been neglected in the past. The committee urges that this program of research identify as one of its highest priorities a focus on the cancer prevention, control, and treatment needs of ethnic minority and medically underserved groups. Recommendation 3-5: Collaborations between NIH and research and medical institutions that serve ethnic minority and medically underserved populations should be increased to improve the study of cancers that affect these groups and to increase the involvement of such entities and populations in scientific research. Recommendation 3-6: NIH should increase its efforts to expand the number of ethnic minority investigators in the broad spectrum of cancer research to improve minority health research. These efforts should (1) assess relevant areas of research needs and ensure that trainees are representative of these disciplines and areas of inquiry, (2) determine guidelines for the quality and expected outcomes of training experiences, and (3) maintain funding for a sufficient period of time to assess the impact of training programs on the goal of increasing minority representation in cancer research fields. Chapter 4: Evaluation of Priority Setting and Programs of Research on Ethnic Minority and Medically Underserved Populations at the National Institutes of Health Recommendation 4-1: NCI should develop a process to increase the representation of ethnically diverse researchers and public representatives serving on all advisory and program review committees so that the makeup of these committees reflects the changing diversity of the U.S. population. NCI should develop an evaluation plan to assess the effect of increased and more diversified ethnic minority community and researcher input on changes in NCI policies and priorities toward ethnic minority cancer issues. Recommendation 4-2: The research needs of ethnic minority and medically underserved groups should be identified on the basis of the burden of cancer in these populations, with an assessment of the most appropriate areas of research (i.e., behavioral and social sciences, biology, epidemiology and genetics, prevention and control, treatment, etc.). Recommendation 4-3: For NCI to address the needs of ethnically diverse and medically underserved populations effectively, the Office of Special Populations Research (or some other designated entity or entities) must possess the authority to coordinate and leverage programs and resources across the divisions and branches of NCI to stimulate research on ethnic minority and medically underserved populations. This authority can be established by providing such an office with: a leadership role in major NCI-wide priority-setting bodies and special resources to fund programs specifically targeted to these populations, or accountability for the institution-wide allocation of program resources. Recommendation 4-4: Investigator-initiated research must be supplemented to ensure that the cancer research needs of ethnic minority and medically underserved populations are addressed. Chapter 5: Advancing State-of-the-Art Treatment and Prevention Recommendation 5-1: NIH and other federal agencies (particularly the Health Care Financing Administration) should coordinate to address funding for clinical trials, particularly to address the additional diagnostic and therapeutic costs associated with prevention trials and third-party payment barriers associated with clinical treatment trials. Recommendation 5-2: NCI should continue to work with other appropriate federal agencies and institutional review boards to explore creative approaches to improving patients' understanding of research and encouraging them to provide consent to participate in research. These approaches should address cultural bias, mistrust, literacy, and other issues that may pose barriers to the participation of ethnic minority and medically underserved groups. Recommendation 5-3: NCI should report on the accrual and retention of ethnic minority and medically underserved populations in clinical trials using a consistent definition for medically underserved populations, including such characteristics as rural versus urban population, insurance status, socioeconomic status, and level of literacy. Recommendation 5-4: NCI should continue to assess its dissemination practices to identify effective cancer information delivery strategies among ethnic minority and medically underserved populations, revise and implement the strategic dissemination plan on the basis of the results of that research, and institute an ongoing system of monitoring to assess its effectiveness. Chapter 6: Cancer Survivorship Recommendation 6-1: NCI should establish a strategic plan to address the cancer survivorship needs of ethnic minority and medically under served groups, including coordination of an overall research agenda on survivorship and a more structured framework for monitoring knowledge, attitudes, and behavior regarding cancer survivorship. Chapter 7: Monitoring and Reporting Recommendation 7-1: The committee recommends a regular reporting mechanism to increase NIH accountability to the U.S. Congress and public constituencies. Such reports should report on data on progress against cancer using the nomenclature "ethnic groups" rather than "racial" groups and include data on medically underserved populations with ethnic group data; provide data on the incidence of cancer at several cancer sites, including those cancers that disproportionately affect ethnic minority and medically underserved populations; consider as one alternative reporting of mortality data in terms of "potential reduction of deaths," a statistic that is based on the lowest mortality rate among U.S. ethnic groups and that emphasizes the need for cross-cultural studies to ascertain optimal strategies for cancer prevention, treatment, and control; link research findings to reductions in cancer incidence and mortality and identify any gaps that may occur in this linkage; and report on "process" developments, such as the number and type of research programs specifically targeted to ethnic minority and medically underserved groups and the contributions of ethnic minority scientists and community groups to the research priority-setting process. Determining the Burden of Disease: Cancer Surveillance and Risk Factor Research The development of sound cancer prevention and control strategies begins with an all-encompassing cancer surveillance effort. Differences in rates of cancer among various population groups detected by cancer surveillance efforts can lend clues to etiologic factors (e.g., environmental exposures, genetic susceptibility, and dietary patterns) and can therefore point to intervention and prevention strategies. In addition, disparities in cancer survival rates can lend clues to inequities in health care service accessibility and delivery, or cultural factors affecting individuals' attitudes toward the health care system. Studies of differences in the cancer experiences of various groups also have the potential to benefit the entire U.S. population, as policies and practices associated with groups that are at lower risk for cancer may be applied to those populations at greater risk. NCI's data collection and surveillance efforts are shaped by Directive No. 15 of the U.S. Office of Management and Budget (OMB), which stipulates that the U.S. population be classified according to one of four basic "racial" categories (American Indian or Alaska Native, Asian or Pacific Islander, black or African American, or white) and one of two ethnic groups (Hispanic or non-Hispanic). Although these classifications carry important historical, social, and political significance in the United States, they are of limited utility for purposes of health research because the concept of race rests upon unfounded assumptions that there are fundamental biological and behavioral differences among racial groups (American Anthropological Association, 1998; Cooper, 1984; President's Cancer Panel, 1997; Williams et al., 1994). In reality, human biodiversity cannot be adequately summarized according to the broad, presumably discrete categories assumed by a racial taxonomy. Furthermore, "racial" groups as defined by OMB are not discernible on the basis of genetic information (American Anthropological Association, 1998; President's Cancer Panel, 1997). The committee considers the term "ethnic group" as a more appro priate descriptor for human population groups, as it appropriately places emphasis on the range of cultural and behavioral factors, beliefs, lifestyle patterns, diet, environmental living conditions, and other factors that may affect cancer risk. NCI's Surveillance, Epidemiology, and End Results (SEER) program was established to provide data on the incidence of cancer in selected geographic areas that may be generalized to the total U.S. population. At this time, the SEER program provides high-quality data that are the best approximation of a national cancer database. The SEER program, however, does not fully describe the burden of cancer for many U.S. ethnic minority and medically underserved populations. It lacks the necessary database concerning the disproportionate cancer incidence, mortality, and survival rates among ethnic minorities and medically underserved groups that would permit NCI to develop and evaluate effective cancer control strategies for these populations. These groups include lower-income or poverty-level whites, particularly those living in rural areas such as Appalachia; African Americans living in rural communities, particularly in the South; culturally diverse American-Indian populations; and Hispanics of national origins not currently included. In addition, the SEER program, as with other NCI programs, fails to consistently collect and report on data for medically underserved populations. These groups, as noted above, suffer from cancer incidence and mortality rates that are disproportionately high and from low cancer survival rates. Medically underserved populations may be defined as low-income individuals, those without medical insurance, those who lack access to quality cancer care, or by other definitions. The committee, however, found no consistent definition of this population in the SEER program or in other NCI programs. A clear, consistent definition of what constitutes the medically underserved population is needed, and cancer surveillance reports should regularly include data on cancer incidence, mortality, and survival rates among the people who make up this population. NIH Portfolio of Research Relevant to the Study of Cancer Among Ethnic Minority and Medically Underserved Populations The committee finds that NIH, and particularly NCI, has funded an impressive array of research projects and training initiatives that may have a demonstrable impact in addressing the burden of cancer among ethnic minority and medically underserved populations. The committee concludes, however, that no blueprint or strategic plan to direct or coordinate this research activity appears to exist. As a result, model programs in one or more institutes are not replicated by other ICs where indicated, some areas of research emphasis receive greater attention than others, and over all funding to address the needs of ethnic minority and medically underserved populations is inadequate. In addition, the committee believes that NCI and NIH should improve the accuracy of their assessment of the amount of resources allocated to addressing the needs of ethnic minority and medically underserved groups. NIH calculates the amount of money allocated to research on minority health programs on the basis of the percentage of ethnic minority individuals in NIH study populations. While the committee wishes to encourage NIH to continue to support the inclusion of diverse study populations in all the research it sponsors, such "percent relevancy" accounting methods are inappropriate as means of indicating overall expenditures for research on ethnic minority health. Diverse study populations do not, in and of themselves, address the research needs of ethnic minority and medically underserved populations unless meaningful research questions relevant to these groups can be posed a priori and answered based on the appropriateness (i.e., diversity and generality) of the study population. Estimates of expenditures on minority health research should therefore be determined by summing research expenditures associated with studies that address a priori research questions focused on the particular needs of ethnic minority and medically underserved communities. Therefore, while NCI reports that $124 million was allocated to research and training programs relevant to ethnic minority and medically underserved populations in fiscal year 1997 (based on percent relevancy accounting methods), the committee believes that the actual figure allocated for these groups is only slightly more than $24 million, or approximately 1 percent of the total NCI budget. Funds allocated to cancer-related minority health research and training programs by other NIH ICs are also small relative to their respective overall budgets. The committee finds these resources are insufficient relative to the burden of disease among ethnic minority and medically underserved communities, the changing U.S. demographics, and the scientific opportunities inherent in the study of diverse populations. Moreover, the committee found no evidence that NIH calculates total expenditures for research on medically underserved groups, apart from calculations derived from data for ethnic minority populations. Although the committee found evidence that NCI sponsors significant behavioral and social science research aimed at examining the range of behavioral, psychosocial, dietary, and other factors that enhance or decrease the risk for cancer or poor cancer survival among ethnic minority and medically underserved groups, behavioral and social science research should be expanded, particularly with respect to prevention and outreach efforts. The agenda for such research should be based on an analysis of the prevalence of particular cancers in these populations and their preventability. Particularly for ethnic minority populations, research is need ed to investigate ethnically appropriate interventions, including culturally competent and linguistically appropriate approaches. Finally, while the committee found evidence of a significant portfolio of training programs designed to increase the numbers of ethnic minority investigators in cancer-related research fields, there is little evidence that NCI or NIH has undertaken a thorough assessment of training programs to determine whether these programs are producing adequate numbers of ethnic minority researchers in all appropriate cancer research fields (e.g., behavioral and social sciences, epidemiology, genetics, and cell biology), and to determine whether training programs have resulted in the increased representation of ethnic minorities in cancer research fields. Further, there is little evidence that guidelines or other training criteria have been established by NCI or NIH to ensure that all trainees receive high-quality instruction and mentoring. Such efforts would improve the planning and implementation of future training programs. Research Priority Setting Establishing priorities among areas of research and scientific inquiry is a complex process that has been addressed in greater detail in a prior IOM study authored by the Committee on the NIH Research Priority-Setting Process (Institute of Medicine, 1998). In general, the present committee supports the recommendations of that previous committee. In particular, the committee supports the recommendations that diversity and public representation on NIH's advisory panels should be increased. The presence of such diverse viewpoints can yield great benefits for NIH, as well as for the public at large (e.g., greater public support for scientific programs, and greater attention to the needs of medically underserved populations). The establishment of the NCI Director's Consumer Liaison Group represents an important step toward this goal, for which NCI should be commended. The committee finds, however, that there has been inconsistent progress in increasing the numbers of scientists, consumers, and community members from and representing ethnic minority and medically underserved communities on NCI advisory panels and committees. Such representation is a critical component of larger efforts to increase constituency input in priority setting and public accountability at NCI. Inclusion of members and representatives of ethnic minority and medically underserved groups on decision-making panels, however, is not sufficient in and of itself to ensure that the concerns of these groups are addressed within NCI. The impact of ethnic minority and medically underserved groups on the advisory and priority-setting process should be evaluated to ensure that policy changes follow from increased representation. As noted above, many factors influence the setting of research priorities at NIH. Priority setting for research on ethnic minority and medically underserved populations, however, is complicated by differences in philosophy regarding how best to address the needs of these groups. NCI's leadership, for example, appears to take the position that research on "special" populations, like other areas of scientific inquiry, cannot be directed or planned and that issues for these groups may be addressed within the larger portfolio of population research (Richard Klausner, director of the National Cancer Institute, presentation to the study committee, June 12, 1998). There is significant evidence to support the position that research often proceeds because of the opportunities presented, and that in many instances, scientific opportunities have resulted in breakthroughs that offer tremendous benefits for ethnic minority and medically underserved communities, as well as for the nation as a whole. For example, the discovery of the role of the hepatitis B virus in the etiology of primary liver cancer, which disproportionately affects Southeast Asian populations, was linked with the development of a vaccine for the prevention of hepatitis B virus infection. The committee finds, however, that the research priority-setting process at NCI and NIH fails to serve the needs of ethnic minority and medically underserved groups. Assessment of the burden of cancer among ethnic minority and medically underserved populations and consideration of these factors within the larger framework of scientific opportunity should be key aspects of the research priority-setting process. This conclusion is also supported in a recommendation made by the NCI Special Action Committee in its 1996 report (National Cancer Institute, 1996a), which advocated a data-driven review of the cancer burden among ethnic minority and medically underserved populations as a means of identifying priority research areas. Two offices serve as logical focal points for the development of a strategic plan to address cancer among ethnic minority and medically underserved populations and assess progress toward that goal. One, the NIH Office of Research on Minority Health (ORMH), serves to coordinate research across NIH institutes on broad ethnic minority health research topics. One of the office's major functions is to stimulate research on minority populations at relevant NIH ICs by providing research supplements to leverage IC resources. ORMH has only recently, however, created a standing advisory panel to help guide the establishment of research priorities (this function had previously been assumed by an ad hoc panel), and it does not participate in the Research Enhancement Awards Program with other specialty offices at NIH to coordinate funding proposals and priorities. Its criteria for program funding and research priorities have therefore been less open to public scrutiny. In addition, ORMH program funding appears to have supplanted rather than leveraged NCI resources for important research and program activities in many instances. Much of the authority within NCI for establishing research priorities among ethnic minority and medically underserved populations would logically fall to the NCI Office of Special Populations Research (OSPR). Currently, however, OSPR lacks the institutional advantages that would ensure that an NCI commitment to research among special populations has a chance to be successful. It has no independent resources to fund a separate portfolio of initiatives for special populations research, has no clear criteria or guidance for recommending the priorities for such initiatives that are dependent on the resources of other parts of NCI, and holds no official position on any of the NCI advisory committees responsible for setting major intramural or extramural priorities. Rather, OSPR serves as the "eyes and ears" to the NCI director regarding research on ethnic minority and medically underserved populations, as it monitors program activities and provides guidance and advice. For the reasons stated above, the committee finds that this model is insufficient to address the needs of ethnic minority and medically underserved populations. These conditions must be rectified or other lines of authority must be established for NCI to benefit from a coordinated program of research on cancer among ethnic minority and medically underserved populations. Finally, the committee is doubtful that the incentives present in the scientific research marketplace will encourage efforts to address critical research questions among the most heavily burdened populations. To increase and improve the quality of research on cancer among ethnic minority and medically underserved populations, NCI must expand requests for applications and other funding mechanisms, especially in areas where critical gaps exist. Clinical Trials and Cancer Information Dissemination The inclusion of ethnic minority and medically underserved individuals in clinical trials and the dissemination of information to their communities and health care providers are critical links connecting scientific innovation with improvements in health and health care delivery. Enhancement of these links is clearly within the purview of NCI and NIH. Although many factors pose challenges to such improvements (e.g., mistrust of the scientific establishment among many members of ethnic minority communities), without a concerted effort to enhance this process, ethnic minority and medically underserved communities will continue to lag behind the American majority in benefiting from the tremendous recent scientific advancements and medical breakthroughs in cancer prevention, treatment, and control. The committee finds that overall, the level of accrual of ethnic minorities in NCI-sponsored treatment trials is proportionate to the disease burden among these populations, with a few exceptions for specific cancer sites. NCI-sponsored prevention trials, however, suffer from poor accrual of ethnic minorities. The recently concluded trials of the chemopreventive agent tamoxifen, for example, demonstrated that the drug successfully prevented breast cancers in thousands of women at high risk for the disease. Only 2 percent of the overall study sample, however, were African American, and even smaller percentages of individuals from other ethnic groups were entered into this study. Such poor accrual raises significant questions regarding the generality of these findings to the total U.S. population. Many factors may affect researchers' ability to recruit ethnic minority and medically underserved populations into prevention trials. One of the most significant challenges lies in the lack of funding for associated follow-up costs. In cancer screening trials, for example, NIH in most instances does not provide funding to cover costs of care for indigent populations with positive test results (Peter Greenwald, acting director, Division of Cancer Prevention, National Cancer Institute, presentation to the study committee, June 12, 1998). The committee considers the federal government's failure to provide follow-up care to needy, uninsured patients to be unethical and urges greater coordination among federal agencies to address the problem. Another factor that may limit the participation of ethnic minority and medically underserved populations in clinical trial research is the complexity of the informed-consent process. Informed consent is the first step in establishing a bond of trust between researchers and research subjects; yet too often informed-consent forms are long, technical, difficult to administer, and not well understood by patients. The committee urges NIH to work with other agencies to explore alternative means of obtaining patient consent (e.g., oral consent) that respect patient autonomy and that do not compromise the informed-consent process. NCI has developed several sophisticated mechanisms for the dissemination of information to cancer patients, clinicians, and others. Much of this effort has been guided by consumer research and an effective marketing plan. Relatively little attention, however, has been devoted to the specific needs of ethnic minority and medically underserved populations. Despite the presence of cancer information materials that have been translated into Spanish and other products targeted to ethnic minority communities, no strategic plan regarding information dissemination to these groups and their health providers appears to exist. Furthermore, the committee did not find evidence of any evaluations of the effectiveness of dissemination practices in ethnic minority and medically underserved communities. Such efforts are necessary to ensure that individuals in these communities, who may be more likely to hold fatalistic attitudes toward cancer and inaccurate beliefs regarding its preventability, are being adequately served. Cancer Survivorship in Ethnic Minority and Medically Underserved Communities Cancer survivors are, in the committee's view, perhaps the most underutilized resource in the War on Cancer. This is especially true among ethnic minority and medically underserved populations, who face numerous cultural, socioeconomic, and institutional barriers to cancer prevention and treatment services. Cancer survivors in these communities are often painfully aware of the lack of services and information that might assist neighbors, friends, and relatives either to avoid or to cope with a cancer diagnosis. Perhaps more important, however, they possess critical expertise on how to reach members of their communities with cancer education and services information. This expertise should be tapped to its fullest. NCI, to its credit, has established an impressive infrastructure of research programs and resources to assist cancer survivors. Greater attention must be paid, however, to the unique needs of ethnic minority and medically underserved communities. As indicated above, the committee did not find evidence of a strategic plan that addresses the needs of these communities and has offered a number of specific recommendations for the establishment of such a plan. Monitoring and Measuring Results To assess progress toward reducing the disparities in the cancer burden among U.S. ethnic and socioeconomic groups, it is important that the U.S. Congress and the public receive regular information regarding NIH activities that include objective performance indicators. The progress that has been achieved toward this goal can be assessed at three levels: (1) reductions in cancer incidence and mortality rates and increased cancer survival rates; (2) changes in cancer risk behavior among affected populations, such as reductions in tobacco use or efficiency of vaccination programs against hepatitis B as a means of reducing risk for primary cancer of the liver; and (3) process-related changes at NIH that reflect new organizational standards, policies, and priorities designed to better address the needs of ethnic minority and medically underserved communities. It is assumed that changes at the organizational level will result in positive outcomes in the behavior of risk groups, which in turn will result in reductions in cancer incidence and mortality and increases in cancer survival.

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