Enhancing the Vitality of the National Institutes of Health Organizational Change to Meet New Challenges (2003) / Chapter Skim
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3. New Opportunities, New Challenges: The Changing Nature of Biomedical Science
3. New Opportunities, New Challenges: The Changing Nature of Biomedical Science
Pages 51-66
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From page 51... ...
All those additions to the traditional research paradigm are placing new demands on approaches to research funding and management because some parts of the scientific frontier require the creation of larger-scale products, significant new infrastructure investments, or the mobilization of interlAt the same time that the present committee was conducting its work, the National Cancer Policy Board of the National Academies was preparing a report, Large-Scale Biomedical Science: Exploring 51
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From page 52... ...
Growing awareness of the association between socioeconomic status and health and health disparities provides new challenges as well as opportunities for research. The opportunities and needs raise the issues of setting research priorities and defining appropriate boundaries for NIH research, but they also raise questions about whether NIH's current institutional structure facilitates or limits the adaptability of its programs.
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From page 53... ...
The research community recognizes a social compact with the public to help improve health by advancing knowledge along all relevant parts of the scientific frontier. At the same time, the translation of discoveries in fundamental and applied science into useful clinical and public health interventions and uses of such interventions to reduce disability, morbidity, and health disparities are the ways the public measures the success of its investments in biological and behavioral research.
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From page 54... ...
with the broad goal of investigating strategies for the prevention and control of some of the most common causes of morbidity and mortality among postmenopausal women, including cancers, cardiovascular disease, and osteoporotic fractures.3 Congress provided special funding, totaling $213 million over 4 years, through the Office of the Director. The WHI has functioned as a trans-NIH consortium and is one of the largest studies of its kind ever undertaken in the United States, involving more than 40 centers nationwide and 162,000 women.
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From page 55... ...
For example, despite a rich evidence base for management of cardiovascular disorders, study after study has demonstrated disconcertingly low rates of compliance with widely disseminated evidence-based treatment guidelines for managing such common cardiovascular conditions as coronary heart disease, congestive heart failure, and high blood pressure. The difficulty in translating the results of clinical trials into clinical practice suggests the presence of multiple barriers to implementation.
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From page 56... ...
, NIMH, the National Institute on Drug Abuse, and the National Institute on Alcohol Abuse and Alcoholism, have substantial portfolios, even whole divisions, that focus specifically on health services research. Another Department of Health and Human Services agency, the Agency for Healthcare Research and Quality (AHRQY, takes the lead in some aspects of health services research and recommends strategies for monitoring and improving quality of care, but it cannot fully address the demand for the full array of such research.
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From page 57... ...
The increasingly recognized links among genetics, health, socioeconomic status, and macroeconomics emphasize the importance of research to examine and decrease the magnitude of health disparities. In 2000, the National Center on Minority Health and Health Disparities was established by the passage of the Minority Health and Health Disparities Research and Education Act of 2000 (PL 106-525)
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From page 58... ...
The process of hunting for disease-related mechanisms that seem to be directly related to genetic material once an expensive and arduous undertaking conducted by individual laboratories and investigatorshas become rapid and highly automated; it is limited primarily by the incompleteness of our understanding of cell regulation, the unexpected complexity of many diseases, and the lack of a rich information base regarding many nongenetic risk factors in the relevant human populations. Despite the spectacular discoveries of
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From page 59... ...
As more information from clinical trials becomes available, the need for standardization and interoperability of clinical databases will increase. Coordinating knowledge gained from a large and growing set of clinical trials with new insights from genetic research could appreciably advance knowledge about the treatment of disease.
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From page 60... ...
In addition to the CGAP, the number of large-scale initiatives in genomics involving multiple institutes has grown. The successful initiation of many of them depended on the institutional leadership at the time combined with growing budgets, according to Francis Collins, director of the National Human Genome Research Institute.
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From page 61... ...
NEW RESOURCE REQUIREMENTS: PATIENT DATABASES AND SPECIMEN BANKS Other trends in biomedical science are influencing the importance of some kinds of data. For example, collections of archived patient information including clinical data, family history, and risk factors and such human biological materials as tissue, blood, urine, and DNA samples are essential for studying the biology, etiology, and epidemiology of diseases, especially if the diseases are linked.
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From page 62... ...
In addition, the widespread use of the records raises a whole set of new ethical issues concerning privacy and confidentiality that must be adequately addressed if the public is to maintain its support for biomedical research. Nonclinical database links will be essential to address environmental, dietary, and behavioral interactions with genetic predispositions (Omenn 20001.
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From page 63... ...
Creating a new breed of interdisciplinary scientists requires rethinking of the training process, including redesigning research training programs and funding mechanisms to support interdisciplinary training, research, and practice. In 1999, NIGMS initiated a new funding mechanism referred to as glue grants, intended to provide the resources to bring together and retain scientists from multiple disciplines to focus on a research topic.
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From page 64... ...
An additional $17 billion was spent on R&D by the biotechnology industry (Pharmaceutical Research and Manufacturers of America, 2001; Biotechnology Industry Organization, 20031. Many initiatives such as the SNPs Consortium, the mouse genome project, the structural genomics consortium, and the more general Small Business Innovation Research Program have involved close collaborations between public funding agencies and private industry.
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From page 65... ...
NIH and FDA are closely involved with the not-for-profit HUPO, and several individual institutes have mounted their own proteomics workshops. SUMMARY Multiple trends are changing the nature and environment of biomedical research, including the persistent need for better approaches to clinical research, health services research, and evidence-based medicine; continuing concerns about health disparities; the looming threats of emerging infectious diseases and bioterrorism; the increased need for large-scale and trans-NIH projects that require 65
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From page 66... ...
66 Enhancing the Vitality of the National Institutes of Health longer-term strategic planning and commitments; the emergence of discovery-driven science and its attendant informatics and data requirements; the need to add new infrastructure elements to the nation's biomedical enterprise; the essential role of interdisciplinary research in many diseases; and expanding relationships between the public and private sector and between the United States and the rest of the world in research.
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