The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines PDF Download
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Author: S.R. Walker
Publisher: Springer Science & Business Media
ISBN: 940111420X
Category : Medical
Languages : en
Pages : 268
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Book Description
For a research-based pharmaceutical company to be successful in the 1990s. it must have a strategic plan for the global development of new chemical entities. Global development can be defined as an attempt to reach all major markets as rapidly as possible and for many companies these will include the United States. Japan. Germany. France. Italy. UK and Canada. which together represent approximately 85% of the pharmaceutical market in the developed world. The mutual acceptance of foreign clinical data would reduce the time and resources required to develop a new medicine for the international market by eliminating the requirement for the routine repetition of clinical studies in local populations. In Japan this has been largely based on the belief that genetic differences in respon siveness may result in a different benefit/risk assessment for a new mediCine. while requests in Europe and the United States for local data relate mainly to methodological and cultural considerations. The importance of this issue has been recognised internationally as it was one of the topics discussed at the International Conference on Harmonisation in Orlando (October 1993) and it is currently on the programme for ICH3 which will be convened in Yokohama in Japan in November 1995.
Author: S.R. Walker
Publisher: Springer Science & Business Media
ISBN: 940111420X
Category : Medical
Languages : en
Pages : 268
Get Book Here
Book Description
For a research-based pharmaceutical company to be successful in the 1990s. it must have a strategic plan for the global development of new chemical entities. Global development can be defined as an attempt to reach all major markets as rapidly as possible and for many companies these will include the United States. Japan. Germany. France. Italy. UK and Canada. which together represent approximately 85% of the pharmaceutical market in the developed world. The mutual acceptance of foreign clinical data would reduce the time and resources required to develop a new medicine for the international market by eliminating the requirement for the routine repetition of clinical studies in local populations. In Japan this has been largely based on the belief that genetic differences in respon siveness may result in a different benefit/risk assessment for a new mediCine. while requests in Europe and the United States for local data relate mainly to methodological and cultural considerations. The importance of this issue has been recognised internationally as it was one of the topics discussed at the International Conference on Harmonisation in Orlando (October 1993) and it is currently on the programme for ICH3 which will be convened in Yokohama in Japan in November 1995.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030908265X
Category : Medical
Languages : en
Pages : 781
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Book Description
Racial and ethnic disparities in health care are known to reflect access to care and other issues that arise from differing socioeconomic conditions. There is, however, increasing evidence that even after such differences are accounted for, race and ethnicity remain significant predictors of the quality of health care received. In Unequal Treatment, a panel of experts documents this evidence and explores how persons of color experience the health care environment. The book examines how disparities in treatment may arise in health care systems and looks at aspects of the clinical encounter that may contribute to such disparities. Patients' and providers' attitudes, expectations, and behavior are analyzed. How to intervene? Unequal Treatment offers recommendations for improvements in medical care financing, allocation of care, availability of language translation, community-based care, and other arenas. The committee highlights the potential of cross-cultural education to improve provider-patient communication and offers a detailed look at how to integrate cross-cultural learning within the health professions. The book concludes with recommendations for data collection and research initiatives. Unequal Treatment will be vitally important to health care policymakers, administrators, providers, educators, and students as well as advocates for people of color.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309452961
Category : Medical
Languages : en
Pages : 583
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Book Description
In the United States, some populations suffer from far greater disparities in health than others. Those disparities are caused not only by fundamental differences in health status across segments of the population, but also because of inequities in factors that impact health status, so-called determinants of health. Only part of an individual's health status depends on his or her behavior and choice; community-wide problems like poverty, unemployment, poor education, inadequate housing, poor public transportation, interpersonal violence, and decaying neighborhoods also contribute to health inequities, as well as the historic and ongoing interplay of structures, policies, and norms that shape lives. When these factors are not optimal in a community, it does not mean they are intractable: such inequities can be mitigated by social policies that can shape health in powerful ways. Communities in Action: Pathways to Health Equity seeks to delineate the causes of and the solutions to health inequities in the United States. This report focuses on what communities can do to promote health equity, what actions are needed by the many and varied stakeholders that are part of communities or support them, as well as the root causes and structural barriers that need to be overcome.
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309165865
Category : Social Science
Languages : en
Pages : 184
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Book Description
As the population of older Americans grows, it is becoming more racially and ethnically diverse. Differences in health by racial and ethnic status could be increasingly consequential for health policy and programs. Such differences are not simply a matter of education or ability to pay for health care. For instance, Asian Americans and Hispanics appear to be in better health, on a number of indicators, than White Americans, despite, on average, lower socioeconomic status. The reasons are complex, including possible roles for such factors as selective migration, risk behaviors, exposure to various stressors, patient attitudes, and geographic variation in health care. This volume, produced by a multidisciplinary panel, considers such possible explanations for racial and ethnic health differentials within an integrated framework. It provides a concise summary of available research and lays out a research agenda to address the many uncertainties in current knowledge. It recommends, for instance, looking at health differentials across the life course and deciphering the links between factors presumably producing differentials and biopsychosocial mechanisms that lead to impaired health.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309124999
Category : Computers
Languages : en
Pages : 334
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Book Description
In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
Author:
Publisher:
ISBN:
Category : African Americans
Languages : en
Pages : 28
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Book Description
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309092116
Category : Social Science
Languages : en
Pages : 753
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Book Description
In their later years, Americans of different racial and ethnic backgrounds are not in equally good-or equally poor-health. There is wide variation, but on average older Whites are healthier than older Blacks and tend to outlive them. But Whites tend to be in poorer health than Hispanics and Asian Americans. This volume documents the differentials and considers possible explanations. Selection processes play a role: selective migration, for instance, or selective survival to advanced ages. Health differentials originate early in life, possibly even before birth, and are affected by events and experiences throughout the life course. Differences in socioeconomic status, risk behavior, social relations, and health care all play a role. Separate chapters consider the contribution of such factors and the biopsychosocial mechanisms that link them to health. This volume provides the empirical evidence for the research agenda provided in the separate report of the Panel on Race, Ethnicity, and Health in Later Life.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309140129
Category : Medical
Languages : en
Pages : 286
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Book Description
The goal of eliminating disparities in health care in the United States remains elusive. Even as quality improves on specific measures, disparities often persist. Addressing these disparities must begin with the fundamental step of bringing the nature of the disparities and the groups at risk for those disparities to light by collecting health care quality information stratified by race, ethnicity and language data. Then attention can be focused on where interventions might be best applied, and on planning and evaluating those efforts to inform the development of policy and the application of resources. A lack of standardization of categories for race, ethnicity, and language data has been suggested as one obstacle to achieving more widespread collection and utilization of these data. Race, Ethnicity, and Language Data identifies current models for collecting and coding race, ethnicity, and language data; reviews challenges involved in obtaining these data, and makes recommendations for a nationally standardized approach for use in health care quality improvement.
Author: American Medical Association
Publisher:
ISBN:
Category : Authorship
Languages : en
Pages : 72
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Book Description
Author: Roberto Lewis-Fernández
Publisher: American Psychiatric Pub
ISBN: 1615370242
Category : Medical
Languages : en
Pages : 366
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Book Description
DSM-5® Handbook of the Cultural Formulation Interview provides the background, context, and detailed guidance necessary to train clinicians in the use of the Cultural Formulation Interview (CFI), which was created as part of the 2007-2013 DSM revision process. The purpose of the CFI -- and this unique handbook -- is to make it easier for providers to account for the influence of culture in their clinical work to enhance patient-clinician communication and improve outcomes. Cultural psychiatry as a field has evolved enormously from the days when it was principally concerned with epidemiological and clinical studies of disease prevalence; it now examines a multitude of issues, primary among them the differing patient, family, and practitioner models of illness and treatment experiences within and across cultures. The editors, all of whom have been intimately involved in the evolution of the field, have designed the book and accompanying videos for maximum instructional and clinical utility. The Handbook boasts many strengths and useful features, including: A detailed description of each of the three CFI components: a core 16-item questionnaire, which can be applied in any clinical setting with any patient by any mental health clinician; an informant version of the core CFI used to obtain information from caregivers; and 12 supplementary modules that expand on these basic assessments. This material facilitates implementation of the CFI by clinicians. Over a dozen clinical vignettes are included to illustrate use of the three components, and the Handbook also includes multiple videos that demonstrate the application of portions of the core CFI, and several supplementary modules. Strategies for incorporating the CFI into clinical training are identified and discussed, furthering the objective of developing culturally-sensitive and astute practitioners. The theoretical bases of the CFI are explored, raising questions for discussion and identifying areas for further research. The CFI is a valuable tool for all patients, not just those judged to be culturally different. The CFI has been called the single most practically useful contribution of cultural psychiatry and medical anthropology to clinical psychiatry, primary care, and medicine in general. DSM-5® Handbook on the Cultural Formulation Interview is the only book on the market that equips readers with the skills and insight to incorporate the CFI into practice, making it a critically important addition to the clinical literature.
