Strategic Planning Document -
Health, Safety and Food R&D

IMPLEMENTATION

CHSF member agencies are committed to implementing these strategies. Program goals and plans include ongoing efforts, redirections, and new initiatives. CHSF subcommittees are organized around the these priorities, and each subcommittee has a more detailed strategic implementation plan. Examples cited below are representative of some of these R&D efforts. These examples are not all-inclusive and do not represent all CHSF activities.

BIOMEDICAL, SOCIO-CULTURAL AND
BEHAVIORAL R&D

1. CLINICAL RESEARCH

Progress in biomedical and clinical research has improved detection and treatment of disease/condition. For example, the location of genes for colon cancer, familial breast cancer and many others has been identified through the Human Genome project. Gene therapy has successfully corrected congenital conditions, and retarded tumor cell growth. Future research must:

• Continue to foster effective interfaces between basic biomedical and clinical research so that research findings will improve health care. We need to better integrate clinical research with outcome research, including continuing Phase IV clinical trials after a therapy is on the market, to evaluate how clinical findings are translated at the community level.

• Increase both the protection provided to human research subjects, and the equity in selection of these subjects. The inclusion of women and men of racial/ethnic minorities in research ensures that all Americans receive an appropriate share of the benefits of research and do not bear a disproportionate burden.

• Address the concern that cost control in academic health centers will diminish the capacity and support for clinical research. The increasing financial vulnerability of academic health centers in a highly competitive environment may place further pressures on clinical faculty to generate income through clinical services, diminishing the time available to pursue clinical research.

• Improve public understanding and use of biomedical and clinical research results.

Agency Roles--NIH is the primary Federal agency for biomedical research. NIH programs include fundamental biomedical research, clinical research and clinical trials in a broad spectrum of disease/conditions such as infectious diseases, chronic diseases, developmental and degenerative diseases. CDC conducts research directly related to a range of public health programs such as infectious, environmentally related, and chronic disease prevention. Examples include identification of infectious agents and biomarkers for environmentally related disease, developing and evaluating diagnostic tests, and developing and evaluating intervention methods.

2. PARTNERSHIP FOR HUMAN PRODUCTIVITY

Research on human capital is based on the premise that people are the world's most important resource. As such, it is important to clarify the processes that shape the intellectual, physical, and emotional aspects of human productivity. Mental and physical health are essential components of human capital, and research devoted to understanding the biomedical, socio-cultural, and behavioral factors that contribute to health is a major component of the Human Capital Initiative. We need to provide a lifespan perspective in identifying the process through which investments by individuals, families and societies maximize returns. Achieving this goal requires an increase in multidisciplinary research among biologists, economists, sociologists, anthropologists and other behavioral scientists in areas such as:

• The motives, attitudes and cognition that influence the acquisition of skills and knowledge which translate into adaptive behaviors.

• The complex processes through which experiences in families, schools, neighborhoods, and workplaces intersect with psychological and biological forces to generate economic and non- economic outcomes.

• The social, behavioral, biomedical, educational and economic factors that influence areas such as reproductive health, family planning, and effective strategies for sustainable development and population stabilization. This research has global and national importance.

Agency Roles--Investing in human capital will require multidisciplinary, long-range research efforts. The human capital research agenda is broad and requires a broad Federal partnership. All member agencies are involved. In particular, NSF is allocating funds to begin an integrated effort to improve our understanding of the formation and use of human capital to support multidisciplinary research and to foster connections between research and policy communities. NIH and VA support research on human development and population-based human behavioral research including strategies to reduce violence. CDC focuses on the community as the patient, identifies important community health problems and seeks to develop individual and environmental interventions for the whole community.

3. BEGINNING INVESTIGATORS

Maintaining the leadership position of the United States in the life sciences depends on producing outstanding beginning investigators and creating an array of professional opportunities for them. This is necessary not only because we need to maintain a continuous pool of scientific researchers but also because young investigators often produce the most creative and innovative research. Therefore, we first need to assess the effectiveness of current programs, both federal and private, that are designed to support and encourage beginning investigators. Programs should address a range of disciplines and encourage applied research and cross-disciplinary activities.

• The current peer review process needs to be re-examined. Beginning investigators may be at a disadvantage relative to established scientists both in the submission of grants and in the rate of success in obtaining funding.

• The effectiveness of existing programs for supporting diversity in science and increasing the number of women and underrepresented minorities undertaking, developing, and maintaining successful research careers needs to be evaluated.

• The balance between research and education at universities and colleges, with an emphasis on quality in both, needs to be assessed. Strategies are needed to recruit outstanding people into life sciences, by keeping a diverse set of career options open.

• There is a critical need to address the growing national concern over the quality of clinical research training. Model programs in academic research training institutions that train physicians interested in patient-oriented research are in financial jeopardy.

Agency Roles--All member agencies are involved with beginning investigators. Particular programs include NIH training programs for beginning investigators, such as the Postdoctoral Fellowship Programs, First Independent Research Support and Transition Award, Career Development Awards and Minority Access to Research Career Training Grant. NSF started a new program in FY 95 to support junior faculty career development including both research and teaching. USDA sponsors postdoctoral fellowship programs and early career scientist awards. Ongoing NSF programs include Research Planning Grants for beginning women and minority investigators, Presidential Faculty Fellowships, and Minority Postdoctoral Fellowships in Biological Sciences. DOE supports several postdoctoral fellowship programs targeted towards genome research and health effects research. CDC programs include Preventive Medicine Residency, Minority Health Program and Epidemic Intelligence Service, and post-doctoral fellowships in infectious disease, and occupational and environmental health.

4. TECHNOLOGY TRANSFER

The purpose of this strategy is to enhance collaboration among research institutions and for-profit organizations to enhance cost-effectiveness and expedite the applications of technology for improved health, safety and food. Current and future policies should be reviewed to assure that unnecessary obstacles to expediting the application of technology for improved health, safety and food are eliminated.

There are significant examples of commercial application of biomedical research findings. Over the last decade, several Federal policies and laws have been successfully implemented to govern technology transfer. While most discussion of technology deals with money and patents, the most technology transfer occurs through people. This is true not only of knowledge transfer from academia or government to industry, but also across national borders. Intellectual property has become an issue worthy of future attention.

Agency Roles--All member agencies have varied technology transfer activities. For example, DOE is developing an Advanced Biomedical Technology Initiative involving a multidisciplinary approach with industry, medical research institutions, national labs, health care providers, and others. Areas of emphasis include minimally invasive procedures in diagnosis and surgery, telemedicine, and advanced prostheses. NIH, CDC and USDA support CRADAs, and innovative research resulting in many patents.

5. DATA NEEDS

The advent of rapid transfer and exchange of electronic information marks the potential for revolutionary development in the fields of health and safety. For example, therapeutic breakthroughs of the 21st century will depend on the analysis and manipulation of biological data. Researchers will need to tap into a series of databases, such as genome, nucleic acid, and protein sequences. They will also need databases that link sequences to three-dimensional shapes and databases that associate functions with shapes. Sequence generation is only the first step. Computer analysis and manipulation are the next step.

The need for better data resources has exceeded the construction of adequate data systems. This includes data systems for biomedical research and monitoring the nation's health and safety. Database resources will enhance the ability of researchers, practitioners and the public to share timely and previously unavailable data to improve the health, productivity and quality of life. The primary issues relate to data handling, systems design, types of databases to be developed, integrating existing systems, quality, accuracy, training, access and privacy.

Agency Roles--All member agencies are involved in data systems. For example, NIH supports several clinical trial databases, the Physicians Data Query, and is currently developing a clinical trial registry which will be accessible to doctors and patients. At DOE and NIH, the human genome program includes the genome data base and the genome sequence data base. NIH collaborates with other Federal agencies to support data on health behaviors and outcome as well as the social factors associated with them. DOE also supports the Bioinformation Infrastructure. NSF has several programs that support development of cross-disciplinary databases. CDC completed an inventory of Public Health Surveillance and Health Information Systems to create a database providing information on health monitoring systems, and is integrating their systems in user-friendly formats.

6. HUMAN SUBJECTS PROTECTION

There are several priority areas for review in the coming months that relate to the mandate to implement the Federal Policy for the Protection of Human Subjects (Common Rule) and to foster protection of human research subjects in research related to health, safety, food and other Federal research mandates. Scientifically sound and ethical research activities can be conducted only if human subjects' protections are adequate. The Human Subjects Research Subcommittee is emphasizing coordination in implementing the Common Rule and maintenance of public confidence in high standards of research. The subcommittee will accomplish this goal using practices compatible with the best uses of limited research resources, and with the goal of fostering effective partnerships among Federal Departments and Agencies, private sector research organizations, and participants in research.

In the next year, several topics will be addressed under two major headings. Working through member agencies, effort will focus on implementing the Common Rule by addressing coordination across Departments and Agencies for promotion of uniformity and consistency. We will examine expansion and improvement of education of Federal employees and those at organizations that carry out Federally-supported or regulated research, including institutions and review board members, administrators and investigators. Another goal is to enhance human subjects protection in other areas. The informed consent process will be evaluated. Researchers will be encouraged to include minorities and women as subjects in research so that all may benefit from research. The need for additional mechanisms to protect vulnerable research subjects will also be evaluated.

HEALTH SYSTEMS AND SERVICES R&D

1. IMPROVE PERFORMANCE OF THE U.S. HEALTH SYSTEM

At the system level, it is essential to understand the determinants of costs, effectiveness, efficiency, and equity of alternative organizational, financing, and management strategies for population-based public health and personal care services in the following areas.

(a) Monitoring, documenting, and analyzing the transformation of the health system--Information needs are growing with the trends toward large, integrated delivery systems in the private sector and more sophisticated purchasing decisions in the public sector. System managers need to understand the potential impact on provider and consumer behavior, while public systems need performance measures and policymakers need information to evaluate results. These goals require up-to-date, integrated information regarding the health care marketplace. This includes frequent collection of State, national and international data for personal care and public health services. This data needs to be matched with demographics and health status.

(b) Developing performance measures for personal care and public health systems--Research is needed on performance measures across the health care spectrum; at the community, state, regional and national levels, as well as the individual plan or public health system level. Research and data need to characterize and assess resources, capabilities, and performance over time, together with the relationship to health outcomes.

(c) Reducing disparities in the availability of services--Whether services are provided in the public or private sector, the health care needs of many Americans are not being met. Systematic research is needed to identify and evaluate the magnitude of the differences in health status and utilization of service by different populations, the determinants of these differences, current intervention strategies, and the cultural appropriateness and sensitivity of the services.

(d) Determining the best approaches for integrating all health services--The rapid pace of horizontal and vertical integration and the growth of managed care have the potential to improve the integration within all health services, including personal care systems and public health systems. Research is needed on how to better integrate personal and public health care systems. Research also needs to describe the effectiveness and efficiency of a broad array of emerging models of service integration.

(e) Assisting in developing the next generation of financing/delivery systems--Managed care and integrated delivery systems will continue evolving rapidly. Research, demonstration and evaluation are needed to develop the next generation of financing and delivery systems and the tools and policies critical to success.

Agency Roles-AHCPR conducts and supports studies of health systems organization, management, financing, and delivery of personal care services. AHCPR, HCFA and VA develop, test and refine personal care system performance measures. CDC develops, tests, and refines public health performance measures. AHCPR and HCFA monitor expenditures and utilization in the private sector and for Medicare/Medicaid beneficiaries. VA develops and tests changes in medical practice. FDA tests methods to improve the utilization of therapies. CDC and NIH develop health baseline data and surveillance systems. Some representative projects with milestones include:

• AHCPR will conduct the National Medical Expenditure Survey (NMES III).
• CDC, HCFA and AHCPR will conduct the National Employer Health Insurance Survey.
• DOT will conduct a pre-hospital morbidity outcome survey.
• AHCPR will conduct an HIV Cost/Utilization study.
• VA will conduct controlled trials of service integration for the chronically ill.
• NIH will conduct feasibility study to link primary care and drug abuse treatment.
• VA will develop unique approaches to pharmacy control.

2. IMPROVE THE QUALITY AND COST-EFFECTIVENESS
OF PERSONAL CARE AND PUBLIC HEALTH SERVICES

Consumers and third party payers are increasingly concerned with verifying the value and cost-effectiveness of the health services they \purchase. They are seeking "Report Cards" and other meaningful information about quality that will enable them to make appropriate decisions about benefits, providers, institutions, prevention and treatment methods, and reimbursement. At the level of individual services, technologies and interventions, we need research that will improve our understanding of how to assess and improve the quality of clinical and public health practice by the following:

(a) Determining which health services are most effective and cost-effective in daily practice--A significant portion of clinical practice today lacks solid evidence of whether the care typically provided makes a difference. Effectiveness studies that take a patient-centered perspective and examine a broad set of outcomes are needed to answer important effectiveness questions. Similarly, a large part of public health practice lacks systematic substantiation of its impact. Research is needed to refine the concepts, methods and analytical techniques that provide the foundation for effectiveness and cost- effectiveness studies. Clinical effectiveness trials are needed, as is research on the relative effectiveness and cost-effectiveness of treatment for the under-65 population.

(b) Identifying the most effective uses of technology--Technology assessments can generate the information needed to make decisions about the most efficient and effective use of technologies for clinical and public health practice. Assessments can provide useful information for practitioners, health care organizations, purchasers and health plan managers. Unfortunately, the accelerating demand for technology assessments has outstripped current capacities. Public-private collaboration is needed to develop technology centers to conduct technology assessments.

(c) Improving the outcomes of clinical and public health practice--Research is needed in developing clinical practice guidelines, systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical conditions, are an important tool for improving clinical practice. They may also be effective tools for improving public health practice. Because many public and private groups are developing guidelines, the Federal government should take the lead developing methods and standards, and updating a clearinghouse for products that meet these standards.

(d) Developing measures for continuous quality improvement--Developing valid and usable quality measures will require integrated research. Measures of quality and effectiveness must be valid, reliable, risk-adjusted and outcome-oriented. These include measures of quality of care needed to choose health plans, to insure that plans meet standards, and to assess quality of care for public health services.

Agency Roles-AHCPR conducts outcomes research, develops clinical practice guidelines, evaluates the effectiveness of technologies and practices, and develops quality measures. CDC evaluates the effectiveness of public health interventions. HCFA assesses Medicaid and Medicare quality. VA and NIH test treatments for efficacy and effectiveness. NIH develops methods to test comparative effectiveness. FDA evaluates safety and effectiveness of products before marketing. Some representative projects with milestones include:

• AHCPR will initiate additional clinical effectiveness studies/trials.
• NIH will develop comparative effectiveness information.
• AHCPR will fund 2 Technology Assessment Centers.
• CDC will develop indicators for assessing quality of public health services.
• VA will develop improved quality measures in mental health and surgery.