The increasing popularity of traditional Chinese medicine (TCM) therapies as health care options warrants thorough examination of the efficacy and safety evidence around these therapies. This thesis explores the intersection of TCM and fatigue using two rigorous methodologies: systematic reviews (SRs) and a randomized controlled clinical trial (RCT). In order to inform the development of an RCT of acupuncture for infectious mononucleosis (mono), a common condition with no known cure, characterized by profound fatigue, we examined the literature on TCM treatment of mono as well as another fatigue condition, idiopathic chronic fatigue (ICF). Additionally, we investigated the literature on the safety of pediatric acupuncture. SRs of TCM efficacy in mono and ICF determined that although clinical trials exist, methodological flaws compromised their validity. In particular, studies published as RCTs were found to lack proper randomization. Inclusion of these studies in the SRs would have been inappropriate and demonstrates the importance of verifying RCT methods. We also present the results of the first known SR of pediatric acupuncture safety. This review was comprehensive, including a large number of databases and publications in any language. Synthesis of the results from those studies that included a denominator produced mild adverse event estimates of 16.3/100 (95% CI 11.221.5) per patient, for RCTs, and 6.3/100 (95% CI 4.97.7) per patient, for cohort studies, with a combined estimate of 7.8/100 (95% CI 6.49.2) per patient. We developed and conducted an RCT of acupuncture for mono, although limitations to recruitment resulted in the enrolment of only three participants. The primary result of the small sample size was to restrict the determination of treatment effect, however, successful implementation of other elements is informative to further research in this area. In addition, we determined the local 5-year Monospot positive incidence rate to be 1.11/1000 (95% CI 0.953.2) for all ages and 5.46/1000 (95% CI 0.8910.0) for the 15-25 year old group. This dissertation examined the evidence around TCM and fatigue and provides recommendations that are aimed at increasing the value of research and the safety and efficacy of practice in this area.

Managers can be seen as information workers who use the raw material of information. The amount of information available for them is for all practical purposes infinite. How can they make the best use of the information available? How can they create a line of action based on that information? These are challenges today's managers are facing. It is challenges like these that justify this study's starting point in the field of information management, in contrast to much previous research on managerial work. In order to create an in-depth understanding of processes in managerial work, this dissertation describes the work of a managing director and his management team over a five year period. The research presented in Management Processes – An Information Perspective on Managerial Work includes a description of the longitudinal case study and a thematic analysis of it. Theoretically the study presents a framework for management processes. The study challenges previous research on information requirements in managerial work and offers an analysis of the various roles information plays in managerial communication processes. The findings include frameworks for these roles and for the forces forming agendas in managerial work. The study suggests two layers of management processes: one execution-level and one development-level. The interplay between these layers is described as an important challenge in managerial work. Several practical implications arise from the study. One is the usefulness of searching for the triggers for managerial mindshifts, the information that helps reframe issues on the managerial agenda. Another implication is the importance of identifying driving forces for development-level issues. Identifying such driving forces can help managers to balance action and reflection. It can thus also help them to avoid the execution trap, a focus on execution at the expense of development efforts. / Diss. Stockholm : Handelshögskolan, 2001

No description available.

Introdução: O Núcleo de Ensaios Clínicos da Bahia conta com estrutura física implantada, potenciais pesquisadores em diversas especialidades e equipe capacitada para execução de protocolos de pesquisa. Apesar disso, possui reduzido número de projetos em andamento e consequentemente, sub-utilização da capacidade instalada. Objetivo: Diagnosticar a situação atual da pesquisa clínica no Hospital Universitário Professor Edgard Santos, identificar os fatores que viabilizam o efetivo desenvolvimento das atividades de pesquisa e elaborar um plano de gestão para reestruturação do Núcleo. Métodos: Estudo observacional e descritivo realizado no Hospital Universitário Professor Edgard santos, em três fases: revisão documental; observação direta da estrutura física e situação de recursos humanos e, entrevista com pesquisadores líderes de grupos de pesquisa clínica do hospital. Resultados: Foram identificados documentos relativos aos Procedimentos Operacionais Padrão das atividades de pesquisa, documento normativo da pesquisa clínica e fluxogramas de processos prioritários. Foram registradas no hospital 109 pesquisas clínicas em 2016 e 90, em 2017 Foram executados 16 protocolos de pesquisa clínica no Núcleo de Ensaios Clínicos em 2017, grande parte do grupo da Hepatologia e com patrocínio da indústria farmacêutica. Estruturalmente o Núcleo está dividido em área administrativa e clínica compartilhada com serviços assistenciais e conta com equipe composta por 8 profissionais. Foram identificados 14 pesquisadores líderes de grupo de pesquisa clínica no hospital e entrevistados 9 desses pesquisadores. A partir das entrevistas, foi elaborada a Matriz SWOT e construído o Mapa Estratégico do Núcleo de Ensaios Clínicos da Bahia, baseado no Balanced Scorecard, com 12 objetivos estratégicos, acompanhados de um Plano de Ação com 12 metas e 35 iniciativas para alcance dos objetivos traçados.Conclusão: O desenvolvimento do planejamento estratégico do Núcleo, pelo mapeamento da pesquisa na instituição poderá auxiliar a alavancar a execução de protocolos clínicos no hospital, permitindo o acesso de pacientes às novas tecnologias não disponíveis no mercado. / Introduction: The Center for Clinical Trials in Bahia has an implanted physical structure, potential researchers in several specialties and a team capable of carrying out research protocols. Despite this, it has a small number of projects in progress and, consequently, underutilization of installed capacity. Objective: To diagnose the current situation of clinical research at the University Hospital Professor Edgard Santos, to identify the factors that make feasible the effective development of research activities and to elaborate a management plan for the restructuring of the Nucleus. Methods: Observational and descriptive study conducted at the University Hospital Professor Edgard santos, in three phases: documentary review; direct observation of the physical structure and human resources situation, and interview with leading researchers from the hospital's clinical research groups. Results: Documents related to the Standard Operational Procedures of the research activities, normative document of clinical research and priority process flowcharts were identified. A total of 109 clinical trials were registered in the hospital in 2016 and 90 in 2017 Sixteen clinical research protocols were performed in the Clinical Trials Nucleus in 2017, a large part of the Hepatology group and sponsored by the pharmaceutical industry. Structurally the Nucleus is divided into administrative and clinical area shared with care services and has a team composed of 8 professionals. We identified 14 leading researchers from the clinical research group at the hospital and interviewed 9 of these researchers. Based on the interviews, the SWOT Matrix was elaborated and the Strategic Map of the Clinical Trials Nucleus of Bahia, based on the Balanced Scorecard, was constructed, with 12 strategic objectives, accompanied by an Action Plan with 12 goals and 35 initiatives to reach the objectives outlined . Conclusion: The development of the Center's strategic planning, by mapping the research in the institution, can help to leverage the execution of clinical protocols in the hospital, allowing patients access to new technologies not available in the market.

Introdução: O orçamento financeiro de estudos clínicos constitui um dos itens que compõem o projeto de pesquisa incluído nos objetivos do modelo de gestão do EPECSUS. A análise criteriosa desse documento, a fim de verificar se os valores oferecidos pelo patrocinador satisfazem os custos institucionais para a realização do estudo, deve ser uma prática comum às instituições que conduzem pesquisa clínica. A análise orçamentária deve ser baseada no fluxograma do estudo e nos valores cobrados na instituição em que o estudo será desenvolvido. Saber defender os direitos da instituição no que tange aos custos de estudos clínicos demonstra bom preparo da Instituição e certamente é apreciado pelos patrocinadores, além de ser parte fundamental na estratégia de manutenção da sustentabilidade dos centros de pesquisa. Métodos: Para desenvolvimento da proposta para cálculo do orçamento de projetos de pesquisa acadêmicos, foram utilizadas técnicas de microcusteio considerando-se valores individuais de insumos e serviços, baseados em valores de aquisição do Hospital Universitário Lauro Wanderley – PB. Foram contempladas as categorizações de custos diretos e indiretos na criação de planilhas em programa Excel, como ferramenta voltada para a execução orçamentária de projetos de pesquisa. Resultados: Chegou-se a um aplicativo em Excel para ser preenchimento pelo pesquisador e gerar um orçamento acurado do estudo, de forma amigável. É constituído por tabelas customizadas para os diferentes itens envolvidos, gerando, ao final, o orçamento consolidado. Desenvolveu-se, ainda, o manual do usuário para orientar o seu preenchimento. As planilhas poderão ser adaptadas às necessidades de cada instituição. Conclusão: O uso da técnica de microcusteio para orçamento de projetos de pesquisa, por meio de planilhas voltadas para este fim, pode determinar de forma mais precisa a viabilidade financeira de cada projeto de pesquisa, bem como melhorar a adequação financeira institucional com o seu implemento no centro de pesquisa, podendo melhorar a adequação financeira institucional. / Introduction: The financial budget for clinical trials is one of the items that make up the research project included in the objectives of the EPECSUS management model. The careful analysis of this document intending to verify if the costs offered by the sponsor satisfy the institutional costs to carry out the study should be a common practice for the institutions conducting clinical research. The budget analysis should be based on the study flow chart and the amounts charged at the institution where the study will be conducted. Knowing how to defend the institution's rights regarding the costs of clinical studies demonstrates the institution's good preparedness and it is certainly appreciated by the sponsors, as well as being a fundamental part of the strategy of maintaining the sustainability of the research centers. Methods: Microcountment techniques were used for the budgeting of research projects based on individual values of inputs and services, based on acquisition values of the Lauro Wanderley University Hospital - PB, as well as the categorization of direct and indirect costs through the creation of Excel spreadsheets as a tool for budget execution of research projects. Results: An application in Excel was reached to be completed by the researcher and generate an accurate study budget, in a friendly way. It is made up of custom tables for the different items involved, generating, in the end, the consolidated budget. The user manual was also developed to guide its completion. The worksheets can be adapted to the needs of each institution. Conclusion: The use of the micro-budgeting technique for budgeting research projects, through spreadsheets designed for this purpose, can determine more precisely the financial viability of each research project, as well as improve the financial adequacy institution with its implementation in the research center.

abstract: With new trends in drug development and testing, it must be determined whether the current state of balance of ethos (the moral norm) and regula (the legal framework) can successfully protect patients while keeping the door to scientific innovation open. The rise of the Clinician Investigator (CI) in both academic and private research introduces a challenge to the protection of subjects in the conflicting dual role of physician and scientist. Despite the constant evolution of regulation and ethical standards, questions about the roles' combined effectiveness in relation to this challenge persist. Carl Elliot describes the suicide of a patient-subject enrolled in an industry-funded physician-run anti-psychotic pharmaceutical drug trial in a 2010 Mother Jones article. Elliot provides a personal account of discrepancies seen in the ethical principles of beneficence, respect for subjects and justice. Through analysis of the problems presented in the case as a model for potential dangers in clinical research, the effectiveness of ethics and law in protecting human subjects is examined. While the lag between ethical standard and regulation has historically shown to cause similar issues, the misconception of current regulation and ethical standards may be contributing to the decrease in subject protections. After IRB approval of subject protections in the research protocol, CIs have been shown to downgrade their responsibility to maintaining ethos through the course of the trial. And, despite their experience in patient-centered ethos as a physician, CIs may be inclined to substitute these values for the ethos of a researcher, with the goal to avoid therapeutic misconception. Maintaining personal responsibility for subjects beyond regulatory structure, and promoting the welfare of the subjects in regards to the ethical standard of research investigators, will provide added security for subjects and decrease opportunity for exploitation in future research. / Dissertation/Thesis / M.S. Biology 2012

Made available in DSpace on 2016-03-04T13:55:11Z (GMT). No. of bitstreams: 2 5.pdf: 1378527 bytes, checksum: b8a14bf9e69c73929eed3088b57f9940 (MD5) license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) Previous issue date: 2014 / Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos/Farmanguinhos. Rio de Janeiro, RJ, Brasil. / A pesquisa clínica patrocinada pelas Indústrias Farmacêuticas vem sofrendo umrecente processo de globalização, particularmente envolvendo países emdesenvolvimento. Através da revisão bibliográfica realizada neste estudocomparamos os processos e realizamos um levantamento das respectivasnormativas vigentes aplicáveis para a aprovação de estudos clínicos demedicamentos no Brasil, Peru, Chile, Argentina, Estados Unidos, Reino Unido eJapão. Além disso, foram apresentados os aspectos positivos da pesquisa clínica noBrasil, assim como as principais dificuldades no processo de aprovação de estudosclínicos no país. A partir do estudo comparativo, foram apresentadas sugestões demelhorias para o processo de aprovação de estudos clínicos no Brasil e para asregulamentações aplicáveis ao país. Concluímos que apesar do Brasil apresentarum ambiente ético e regulatório bem estabelecido e alinhado com normasuniversais, a compreensão dos processos regulatórios de outros países, quemedeiam os respectivos trâmites para a aprovação de estudos clínicos, podecontribuir para a melhoria do processo de aprovação de um estudo clínico no Brasile para a sua respectiva regulamentação. / Clinical research sponsored by Pharmaceutical Companies has been suffering a recent process of globalization, particularly involving developing countries. Through a literature review done in this study, we compared the process and specific applicable norms related to the approval of drug clinical trials in the following countries: Brazil, Peru, Chile, Argentina, the United States of America, United Kingdom and Japan. Furthermore, we presented the positive aspects of clinical research in Brazil as well as the main difficulties of the approval process for clinical research in the country. Based on the comparative study, we presented suggestions to improve the clinical trial approval process in Brazil and for the applicable regulation. We concluded that although Brazil has a well-established and ethical regulatory environment aligned with universal norms, the understanding of the regulatory processes of others countries that mediate their procedures for approving clinical studies, can contribute to the improvement of the Brazilian approval process and its applicable regulation.

Introdução: O Núcleo de Ensaios Clínicos da Bahia conta com estrutura física implantada, potenciais pesquisadores em diversas especialidades e equipe capacitada para execução de protocolos de pesquisa. Apesar disso, possui reduzido número de projetos em andamento e consequentemente, sub-utilização da capacidade instalada. Objetivo: Diagnosticar a situação atual da pesquisa clínica no Hospital Universitário Professor Edgard Santos, identificar os fatores que viabilizam o efetivo desenvolvimento das atividades de pesquisa e elaborar um plano de gestão para reestruturação do Núcleo. Métodos: Estudo observacional e descritivo realizado no Hospital Universitário Professor Edgard santos, em três fases: revisão documental; observação direta da estrutura física e situação de recursos humanos e, entrevista com pesquisadores líderes de grupos de pesquisa clínica do hospital. Resultados: Foram identificados documentos relativos aos Procedimentos Operacionais Padrão das atividades de pesquisa, documento normativo da pesquisa clínica e fluxogramas de processos prioritários. Foram registradas no hospital 109 pesquisas clínicas em 2016 e 90, em 2017 Foram executados 16 protocolos de pesquisa clínica no Núcleo de Ensaios Clínicos em 2017, grande parte do grupo da Hepatologia e com patrocínio da indústria farmacêutica. Estruturalmente o Núcleo está dividido em área administrativa e clínica compartilhada com serviços assistenciais e conta com equipe composta por 8 profissionais. Foram identificados 14 pesquisadores líderes de grupo de pesquisa clínica no hospital e entrevistados 9 desses pesquisadores. A partir das entrevistas, foi elaborada a Matriz SWOT e construído o Mapa Estratégico do Núcleo de Ensaios Clínicos da Bahia, baseado no Balanced Scorecard, com 12 objetivos estratégicos, acompanhados de um Plano de Ação com 12 metas e 35 iniciativas para alcance dos objetivos traçados.Conclusão: O desenvolvimento do planejamento estratégico do Núcleo, pelo mapeamento da pesquisa na instituição poderá auxiliar a alavancar a execução de protocolos clínicos no hospital, permitindo o acesso de pacientes às novas tecnologias não disponíveis no mercado. / Introduction: The Center for Clinical Trials in Bahia has an implanted physical structure, potential researchers in several specialties and a team capable of carrying out research protocols. Despite this, it has a small number of projects in progress and, consequently, underutilization of installed capacity. Objective: To diagnose the current situation of clinical research at the University Hospital Professor Edgard Santos, to identify the factors that make feasible the effective development of research activities and to elaborate a management plan for the restructuring of the Nucleus. Methods: Observational and descriptive study conducted at the University Hospital Professor Edgard santos, in three phases: documentary review; direct observation of the physical structure and human resources situation, and interview with leading researchers from the hospital's clinical research groups. Results: Documents related to the Standard Operational Procedures of the research activities, normative document of clinical research and priority process flowcharts were identified. A total of 109 clinical trials were registered in the hospital in 2016 and 90 in 2017 Sixteen clinical research protocols were performed in the Clinical Trials Nucleus in 2017, a large part of the Hepatology group and sponsored by the pharmaceutical industry. Structurally the Nucleus is divided into administrative and clinical area shared with care services and has a team composed of 8 professionals. We identified 14 leading researchers from the clinical research group at the hospital and interviewed 9 of these researchers. Based on the interviews, the SWOT Matrix was elaborated and the Strategic Map of the Clinical Trials Nucleus of Bahia, based on the Balanced Scorecard, was constructed, with 12 strategic objectives, accompanied by an Action Plan with 12 goals and 35 initiatives to reach the objectives outlined . Conclusion: The development of the Center's strategic planning, by mapping the research in the institution, can help to leverage the execution of clinical protocols in the hospital, allowing patients access to new technologies not available in the market.

Introdução: O orçamento financeiro de estudos clínicos constitui um dos itens que compõem o projeto de pesquisa incluído nos objetivos do modelo de gestão do EPECSUS. A análise criteriosa desse documento, a fim de verificar se os valores oferecidos pelo patrocinador satisfazem os custos institucionais para a realização do estudo, deve ser uma prática comum às instituições que conduzem pesquisa clínica. A análise orçamentária deve ser baseada no fluxograma do estudo e nos valores cobrados na instituição em que o estudo será desenvolvido. Saber defender os direitos da instituição no que tange aos custos de estudos clínicos demonstra bom preparo da Instituição e certamente é apreciado pelos patrocinadores, além de ser parte fundamental na estratégia de manutenção da sustentabilidade dos centros de pesquisa. Métodos: Para desenvolvimento da proposta para cálculo do orçamento de projetos de pesquisa acadêmicos, foram utilizadas técnicas de microcusteio considerando-se valores individuais de insumos e serviços, baseados em valores de aquisição do Hospital Universitário Lauro Wanderley – PB. Foram contempladas as categorizações de custos diretos e indiretos na criação de planilhas em programa Excel, como ferramenta voltada para a execução orçamentária de projetos de pesquisa. Resultados: Chegou-se a um aplicativo em Excel para ser preenchimento pelo pesquisador e gerar um orçamento acurado do estudo, de forma amigável. É constituído por tabelas customizadas para os diferentes itens envolvidos, gerando, ao final, o orçamento consolidado. Desenvolveu-se, ainda, o manual do usuário para orientar o seu preenchimento. As planilhas poderão ser adaptadas às necessidades de cada instituição. Conclusão: O uso da técnica de microcusteio para orçamento de projetos de pesquisa, por meio de planilhas voltadas para este fim, pode determinar de forma mais precisa a viabilidade financeira de cada projeto de pesquisa, bem como melhorar a adequação financeira institucional com o seu implemento no centro de pesquisa, podendo melhorar a adequação financeira institucional. / Introduction: The financial budget for clinical trials is one of the items that make up the research project included in the objectives of the EPECSUS management model. The careful analysis of this document intending to verify if the costs offered by the sponsor satisfy the institutional costs to carry out the study should be a common practice for the institutions conducting clinical research. The budget analysis should be based on the study flow chart and the amounts charged at the institution where the study will be conducted. Knowing how to defend the institution's rights regarding the costs of clinical studies demonstrates the institution's good preparedness and it is certainly appreciated by the sponsors, as well as being a fundamental part of the strategy of maintaining the sustainability of the research centers. Methods: Microcountment techniques were used for the budgeting of research projects based on individual values of inputs and services, based on acquisition values of the Lauro Wanderley University Hospital - PB, as well as the categorization of direct and indirect costs through the creation of Excel spreadsheets as a tool for budget execution of research projects. Results: An application in Excel was reached to be completed by the researcher and generate an accurate study budget, in a friendly way. It is made up of custom tables for the different items involved, generating, in the end, the consolidated budget. The user manual was also developed to guide its completion. The worksheets can be adapted to the needs of each institution. Conclusion: The use of the micro-budgeting technique for budgeting research projects, through spreadsheets designed for this purpose, can determine more precisely the financial viability of each research project, as well as improve the financial adequacy institution with its implementation in the research center.

nÃo hà / Apresentar diretrizes bÃsicas que sirvam de subsÃdios para um modelo de estrutura fÃsica, organizacional e mÃtodo de administraÃÃo, passÃvel de ser desenvolvido em um Centro de Pesquisa ClÃnica, pÃblico ou privado, à o objetivo deste trabalho, que foi construÃdo a partir de pesquisa bibliogrÃfica. Os ensaios ou estudos clÃnicos constituem o estÃgio mais caro e mais longo do processo de desenvolvimento de um medicamento e sÃo desenvolvidos em Centro de Pesquisa ClÃnica que à uma organizaÃÃo pÃblica ou privada, legitimamente constituÃda e habilitada para a realizaÃÃo de pesquisa clÃnica. O conjunto de regras e procedimentos junto com os recursos materiais (edifÃcios, equipamentos, etc.) forma a estrutura de uma organizaÃÃo. A abordagem sobre a estrutura para Centro de Pesquisa ClÃnica ocorreu em dois eixos: a Estrutura FÃsica e a Estrutura Organizacional. O modelo de administraÃÃo discutido partiu da anÃlise dos modelos existentes, identificando-se um mesmo princÃpio em todos eles, abrangendo as funÃÃes administrativas essenciais para qualquer instituiÃÃo: o planejamento, a organizaÃÃo, o comando, a coordenaÃÃo e o controle. Customizamos um modelo de avaliaÃÃo de empresas para a consecuÃÃo do PrÃmio Nacional da Qualidade, pela FNQ, que à utilizado por inÃmeras organizaÃÃes lÃderes de classe mundial adequando-o em um modelo de AdministraÃÃo da Qualidade. Definiu-se 12 fundamentos necessÃrios para a administraÃÃo de um Centro de Pesquisa, qualificando-o para competir em um mercado globalizado do sÃculo XXI, quais sejam: Pensamento SistÃmico; LideranÃa; VisÃo de Futuro; EstratÃgias e Planos: Planejamento; ValorizaÃÃo das Pessoas: gestÃo de competÃncias; Aprendizado Organizacional; Cultura e InovaÃÃo; OrientaÃÃo por Processos e InformaÃÃo; GeraÃÃo de Valor; Conhecimento e entendimento sobre o Cliente e o Mercado; Desenvolvimento de Parcerias; Responsabilidade Social. / The aim of this work, built from bibliographical research, is to present basic guidelines that serve as support for a model of physical and organizational structure, and method of administration, to be implanted in a Clinical Research Center, public or private. The clinical trials or studies constitute the most expensive and time-consuming part of the drug development process. It usually takes place at a Clinical Research Center, a public or private organization legally constituted and authorized to perform clinical research. The set of rules and proceedings together with the material resources (buildings, equipments, etc.) form the structure of an organization. The approach on the structure for the Clinical Research Center occurred in two areas: Physical Structure and Organizational Structure. The model of administration discussed was based on the analysis of the existent models, identifying the same basis in all of them, including the administrative essential functions for any institution: the planning, organization, command, coordination and control. We customized a model of evaluation of companies, used by the National Quality Foundation in the attainment of the National Prize of Quality, which is used by many leading organizations world-class, adapting it into a model of Quality Management, in which we defined 12 necessary basis for the administration of a Research Center, in order to qualify it to compete in the globalized market of the XXI century, which are: Systemic Thought; Leadership; Vision of the Future; Strategies and Plans: Projection; Adding Value to People: management of competences; Systematic Learning; Culture and Innovation; Direction by Processes and Information; Generation of Value; Knowledge and understanding of the Client and the Market; Development of Partnerships; Social Responsibility.