As an oncology clinical researcher at an urban hospital, I reflected on patient stories and see overlying themes: financial hurdles, treatment delays, difficulties completing treatment, ineligibility for clinical trials, and other barriers to care specific to urban patients. Delays in cancer treatment have been linked to a decrease in overall survival; consequently, reducing observed blockades could be a matter of life and death. Clinical trials provide more treatment options while researching possible standard of care therapies for future patients. As novel anticancer treatments become more biomolecule specific and low minority enrollment on clinical trials used to validate these drugs continues, I ask, “Why”? I believe urban patients are unethically excluded from participating in clinical trials by overly restrictive study eligibility criteria, high out-of-pocket costs, lengthy informed consents written either not at the patient’s reading level or not in their language, as well as other deterrents associated with low socioeconomic status. More minority representation in clinic trials is necessary to ensure drugs seeking FDA approval are more representative of the population. I argue more needs to be done to make studies more inclusive. Though challenges enrolling urban patients onto clinical trials remains, I believe there are still ways to enhance their cancer care: 1) identifying or writing treatment clinical trials that are more inclusive; and 2) developing studies with interventions that target socioeconomic barriers to care. / Urban Bioethics

Assent, currently defined as “a child’s affirmative agreement”, is a way in which some children are included in the decision-making process regarding their participation in clinical research. Current guidelines for paediatric research do not provide clear directions for how assent should be handled, resulting in confusion among researchers. The goal of this research project was two-fold: to examine the ethical arguments for assent with a view to developing concrete moral justification for its being required, and to develop a framework of significant issues for an investigator to consider when deciding whether to gain assent from an individual child. After an in-depth analysis, it was determined that the ethical justification for assent arises from the researcher’s dual obligations to the child and his parents. A child’s parents are responsible for determining when and how he will develop his decision-making ability. The researcher has an obligation to engage with the child in a manner that complements their pedagogical style, while also treating the child as a being of moral worth. As a child’s family context has an influence on his participation in medical decision-making, further research on children’s daily decision-making within their families is needed. To this end, a three-phase research agenda was designed: a qualitative focus group study, a quantitative questionnaire study, and a discussion panel with paediatric experts. The children in these studies clearly desired to make decisions but did not express an interest in having complete control. They expected their parents to provide them with decision-making guidance in most aspects of their lives. Data collected from parents illustrated that they often tried to involve their children in decisions by providing them with limited options from which to choose and encouraging family discussion. Participants in the discussion panel stated that they did not expect children to make an independent decision regarding medical care, but they might attempt to give children smaller decisions, such as the arm used to provide a blood sample. These results indicate that the definition of assent should be revised, emphasising the child’s involvement in the overall decision making process, without an expectation of an “affirmative agreement”, likely mimicking a familiar decision-making setting from his family context. This could then be documented in the child’s clinical notes through a brief description of all relevant interactions and/or discussions with the child, resulting in an accurate portrayal of the entire assent process.

L’essor de la statistique en médecine est l’ultime étape de la quête d’une médecine scientifique poursuivie tout au long de l’histoire de la discipline. Cette méthodologie de production des preuves médicales est reconnue par tous comme un gage de qualité justifiant les prises de décisions médicales au niveau individuel et collectif.Initialement, le concept est une démarche pédagogique prônant l’autonomie de chaque praticien dans la recherche, l’analyse critique et l’application personnalisée des preuves disponibles. La démarche rejette le dogmatisme médical. Ce concept a été et demeure largement controversé. Pour autant, il a rapidement traversé les frontières pour devenir une exigence déontologique et juridique au risque d’une dérive normative.La priorité laissée à la qualité méthodologique des preuves médicales au détriment de leur applicabilité en vraie-vie pose question.L’hypothèse de ce travail est qu’il existe, aux différentes étapes du circuit de la preuve médicale, des biais cognitifs et/ou méthodologiques qui peuvent impacter l’exercice pertinent de la médecine malgré son alibi scientifique.Au travers de l’exemple des maladies respiratoires chroniques, ce travail épistémologique se propose de caractériser la preuve médicale. Il décompose le circuit de la preuve médicale pour analyser sa méthodologie de production, ses sources, vecteurs et cibles de diffusion, les conséquences de l’implication des agences réglementaires et de l’Etat dans son applicabilité mais aussi les biais cognitifs auxquels sont soumis médecins et patients. Il vise à déterminer avec transparence sur quelles preuves la médecine se fonde pour en permettre une utilisation pertinente. / The use of statistics in medicine is the final step for the development of scientific medicine pursued throughout the history of the discipline. This method of production of medical evidence is recognized by healthcare professionals, drug manufacturers and political institutions as a pledge of quality that justifies medical decision-making at the individual and collective levels. Initially, the concept is an educational approach advocating the autonomy of each practitioner in bibliographic research and critical appraisal of available evidence for their use in the context of personalized medicine. The approach rejects medical dogmatism. This concept has been and remains largely controversial. However, it has quickly become a deontological and legal requirement that could drift back to dogmatism. The priority given to the methodological quality of medical evidence while poor attention is paid to its real-life applicability raises concerns. In this work we hypothesize that, from the production to the use of medical evidence there are cognitive and/or methodological biases that may alter the relevance of medicine practice despite its scientific alibi. Through the example of chronic respiratory diseases, this epistemological work aims at characterizing the medical evidence. To do so, we analyzed its production methodology, the sources, vectors and targets for dissemination, the consequences of the involvement of regulatory agencies and governments in its applicability and the cognitive biases that may apply to physicians and patients. It aims at determining transparently on what type of evidence medicine is based to enable its relevant practice.

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O presente estudo teve por objetivo observar os níveis de concordância entre a avaliação clínica e fotográfica digital no diagnóstico de desempenho de restaurações posteriores (Classe I e Classe II) em resina composta. As avaliações clínicas foram feitas por dois examinadores (C1 e C2) calibrados (e-calib) usando critérios da Fédération Dentaire Internationale (FDI) considerando propriedades estéticas, funcionais e biológicas. Em cada momento de avaliação clínica, uma fotografia digital padronizada de cada restauração foi realizada. Dois examinadores digitais (D1 e D2), igualmente calibrados e usando os mesmos critérios avaliaram todas as imagens obtidas nas avaliações clínicas. Os dados foram analisados com Coeficiente de Cohen Kappa e teste não paramétrico de Kruskal-Wallis e o teste de Dunn de comparação múltipla, com nível de significância de 5%. Comparações intra (mesmo método) e inter (métodos diferentes) examinadores foram feitas. Os resultados revelaram que os níveis de concordância variaram de \"Perfeito\" a \"Justo\". Houve diferença significante (p < 0.05) intra-examinadores; entre C1 e C2 para o manchamento marginal; entre D1 e D2 para brilho superficial, estabilidade de cor e translucidez, forma anatômica, e fratura do material e retenção; inter-examinadores foram encontradas diferenças significantes em todas as propriedades estéticas (brilho superficial, manchamento marginal, estabilidade de cor e translucidez e forma anatômica) e funcionais (fratura do material e retenção e adaptação marginal) observadas. A associação entre a imagem digital e o exame clínico pode ser uma ferramenta promissora para detecção de falhas precoces em restaurações de resina composta, necessitando de mais estudos que investiguem o método digital. / The present study aimed to evaluate the agreement levels between clinical and digital photographic assessments on the performance of posterior composite resin restorations (Class I and Class II). The clinical assessments were made by two examiners (C1 and C2) calibrated through e-calib with the Fédération Dentaire Internationale (FDI) criteria considering esthetic, functional and biological properties. In each moment of clinical assessment, standard digital photographs of each restoration were obtained. Two digital examiners (D1 and D2), equally calibrated and using the same criteria, evaluated all the images obtained in the clinical assessment. The data were analyzed with the calculation of Cohen Kappa coefficient, Kruskal-Wallis non-parametric test and Dunn\'s multiple shared test, with significance of 5%. Intra (same method) and inter (different methods) comparisons were realized. The results showed that agreement levels varied from \"Perfect\" to \"Fair\". There was a significant difference (p < 0.05) intra-examiners; between C1 and C2 to the marginal staining parameter; between D1 and D2 in the parameters surface luster, colour match and translucency, esthetic anatomical form and fracture of material and retention; inter-examiners was noticed significant difference in all the esthetic (surface luster, colour match and translucency, marginal staining, esthetic anatomical form) and functional properties (fracture of material and retention and marginal adaptation) observed. The association between the digital image to the clinical exam may be a promising tool associated with the clinical method to detect early failures in composite resin restorations, requiring further studies investigating the digital method.

Para a condução de um estudo clínico hoje é necessária colaboração e participação de um diverso grupo de partes interessadas, incluindo patrocinadores do estudo, governo, agencias regulatórias, comitês de ética, pacientes, investigadores clínicos. Os centros de pesquisa clínica, local onde estudos clínicos são realizados, devem conseguir gerenciar tudo isso para que possam conduzir os estudos clínicos de forma a garantir a acurácia e qualidade dos dados, bem como a segurança dos sujeitos de pesquisa. Na busca da melhoria contínua do desempenho de uma organização, a Teoria das Restrições atua por meio de ações gerenciais sobre os gargalos, apresentando ferramentas que podem auxiliar na compreensão de um problema complexo, entre elas está a Árvore da Realidade Atual (ARA). É importante realizar um diagnóstico do ambiente interno da organização, sendo predecessor às mudanças e intervenções nas organizações de forma eficaz. O encontro de um problema leva a identificação de uma oportunidade de melhoria dos processos. Assim, o objetivo deste trabalho é verificar se a ARA pode auxiliar a gestão de uma unidade de pesquisa clínica, já que se trata de um problema complexo, apontando oportunidades de melhoria. Para isso, foi realizado um estudo de caso na Unidade de Pesquisa Clínica (UPC) do HCFMRP-USP, sendo realizadas todas as etapas para construção da ARA. Como resultado, foi construída a ARA, sendo identificados 257 Efeitos Indesejáveis (EIs) e 04 causas raízes desses efeitos, que juntas constituem os problemas centrais do centro. Para cada uma das causas raízes foi proposto um plano de ação. Conclui-se que a utilização da ARA mostrou-se eficiente no âmbito de pesquisa clínica, uma vez que conseguiu sintetizar as principais oportunidades de melhoria de um centro de pesquisa, e direcionar os esforços dos gestores em ações específicas e estratégicas. / Cooperation among a diverse group of stakeholders, including: research, sponsors industry, academia, government, nonprofit organizations, clinical investigators, patients, physicians, and regulators is necessary in conducting a clinical trial today. The investigators and sites where clinical studies are conducted, should be able to manage it all those things, so they can conduct clinical studies to ensure the accuracy and quality of data as well the safety of research subjects. In pursuit of continuous improvement of an organization\'s performance, Theory of Constraints operates through management actions on bottlenecks, with tools that can assist in the understanding of a complex problem, among them is the Current Reality Tree (CRT). It is important to make a diagnosis of the organization\'s internal environment, and before the changes and effectively interventions in organizations. Finding a problem leads to the identification of an opportunity to improve process. The aim of this study is to verify if the Current Reality Tree can assist the management of a clinical research site, since it is a complex problem, pointing out opportunities for improvement. For this, we conducted a study case in the Clinical Research Unit (UPC) HCFMRP-USP, being applied all steps from CRT methodology. As a result, it was built ARA, identified 257 Undesirable Effects (EIs) and 04 root causes of these effects, which together are the core problems. For each of the root causes was proposed a plan of action. With this it has been concluded that the use of the ARA was efficient under clinical research, one could summarize the main opportunities for improvement of a site, and direct the efforts of managers in specific and strategic actions.

A pesquisa clínica é considerada um método inovador em medicina clínica e essencial para o desenvolvimento de novas drogas. No Brasil, a pesquisa clínica teve um grande avanço após a publicação da Resolução 196/96 pelo Conselho Nacional de Saúde e Ministério da Saúde, que foi baseada na Declaração Helsinque e Organização Mundial de Saúde. Desta forma, a realização de estudos clínicos dentro dos padrões éticos exigidos requer infra-estrutura adequada e equipe treinada. O objetivo deste estudo foi avaliar os grupos que realizam pesquisa clínica no Brasil em relação a: qualificação profissional, conhecimento regulatório e curso em Boas Práticas Clínicas (BPC). Trata-se de um estudo transversal com investigadores (PI) e sub-investigadores (SI) que foram identificados inicialmente pelo Currículo Lattes do Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq). A busca utilizou palavras-chave específicas que discriminam apenas aqueles que têm experiência com ensaios clínicos. Após consentimento informado, os voluntários foram submetidos a um questionário composto de questões qualitativas e quantitativas. Foram entrevistados 100 PI e SI. As regiões brasileiras mais representativas foram Sudeste (68%) e Sul (18%). As principais instituições envolvidas foram do complexo HCFMUSP, UNIFESP e outras instituições federais. Os centros foram classificados como públicos e universitário (54%) e instituições acadêmicas e privadas (23%). Com relação aos pesquisadores, 56% dedicam até 10hrs semanais para pesquisa clínica e 73% deles exercem atividades acadêmicas. No ano passado, 35% dos entrevistados tiveram 1 ou 2 artigos científicos internacionais publicados. No que diz respeito à experiência em ensaios clínicos, 57% e 77% tinham experiência na fase II e III respectivamente. Pós graduação foi observada em 86%, sendo Doutor (62%)a maior titulação observada. Sobre conhecimento BPC, 91% alegaram conhecer, embora apenas 74% tivessem curso formal. Todas as equipes de pesquisa clínica são multidisciplinares com maior participação de enfermeiros e farmacêuticos. Com relação à equipe, 88% tinham conhecimento em BPC, embora apenas 77% tivessem cursos formais. Com relação aos estudos clínicos realizados 36%, 60% e 44% são fases II, III e IV respectivamente. O tempo para aprovação dos protocolos clínicos é de um mês em 45% dos centros. A maior dificuldade em contratar profissionais nesta área foi a falta de recursos humanos qualificados (45,3%). Os benefícios da pesquisa clínica identificados foram: intercâmbio de conhecimento (35%), benefícios dos voluntários (17,8%) e melhoria na qualidade do cuidado á saúde (5,7% ). A expectativa da pesquisa clínica no Brasil citada pelos pesquisadores foi considerada boa (60,5%), mas é deficiente em incentivo e recursos. Em conclusão, os investigadores possuem qualificação e conhecimento adequado para realizar estudos clínicos, porém, existe a necessidade de maior treinamento. Os centros em que os investigadores atuam, possuem equipe treinada e infra-estrutura adequada para realização de ensaios clínicos fase II, III e IV. A pesquisa clínica possibilita ganho de conhecimento científico, atualização sobre novas condutas terapêuticas, intercâmbio de conhecimento com outras Instituições, tanto nacionais como internacionais. / Clinical trial is considered a breakthrough method in medicine and essential to the development of new drugs. In Brazil, clinical trials increased after the publication of the resolution 196/96 by the Health National Cabinet and Health Ministry, that was based on Helsinki declaration and WHO, among other relevant clinical trial documents. Clinical trials that comply with those regulations require an appropriate infrastructure and team qualification. The goal of this study was to evaluate general clinical trial groups in Brazil: professional qualification, regulatory knowledge and Good Clinical Practice. This is a transversal study with investigators (PI) and sub investigator (SI). PI and SI data were initially obtained from Curriculum Lattes from National Advice of Scientific and Technological Development (CNPq). The selection was made by using specific keywords which would discriminate those who in fact have clinical trial experience. After informed consent, the volunteers were submitted to a questionnaire which was composed of qualitative and quantitative questions. A hundred PI and SI were interviewed. The most representative Brazilian regions were Southeast (68%) and South (18%). The main institutions involved were HCFMUSP complex, UNIFESP and others federal institutions. The centers were classified in academic public institutions (54%) and private academic institutions (23%). With regard to the investigators 56% of them dedicated 10hrs per week for clinical trial and 73% have academic activities. Last year, 35% had 1 or 2 international scientific article published. Concerning the experience in trials, 57% and 77% had experience phase II and III, respectively. Academic graduation is observed in 86% of them and the higher titrations is Doctor (62%). 91% had GCP knowledge although only 74% had a formal training. About the team, all of them are multidisciplinary with majority of nurses and pharmaceuticals. 88% had GCP knowledge although only 77% had formal training. 36%, 60% and 44% of clinical trials were in phase II, III and IV. The time for approval of clinical protocols is one month in 45%. The major difficult detected was recruitment of professionals with suitable training and knowledge (45%). The benefits cited by the investigators were: improving exchange of knowledge (35%), volunteers benefits (18%) and improvement in quality of care (6%). The expectation of clinical trials in Brazil cited by the investigators was good and increasing (60%) but is deficient in incentive and resource. In conclusion, researchers have appropriate skills and knowledge to perform clinical studies however there is still a need for training. The centers where the researches work, have trained staff and adequate infrastructure for conducting clinical trials phase II, III and IV. Clinical research provides gain of scientific knowledge, update on new therapeutic conducts, sharing knowledge with other institutions, both national and international.

A promoção do business process managment (BPM) tem o potencial de trazer diversos benefícios para organizações de diferentes tamanhos, setores de atuação, regiões geográficas ou níveis de maturidade em gerenciamento de processos. Um dos fatores críticos de sucesso para a promoção de BPM é o seu alinhamento com o planejamento estratégico da organização. Este trabalho procura explorar o potencial de facilitação da promoção de BPM em uma unidade de pesquisa clínica (UPC) por meio do alinhamento com o planejamento estratégico. A pergunta de pesquisa que se pretende responder é: quais são os benefícios de um diagnóstico e planejamento estratégico prévios à promoção de um programa de BPM em uma unidade de pesquisa clínica (UPC)? Assim, o objetivo é definir as etapas e auxiliar na condução de um planejamento estratégico em uma unidade de pesquisa clínica, identificando posteriormente os benefícios decorrentes desta prática para a promoção de um programa de BPM. O método utilizado no trabalho foi a pesquisa-ação. Concluiu-se que a análise e estruturação inicial do processo de planejamento estratégico foi adequado como preparação para um primeiro ciclo de promoção de BPM na organização focal. Com base nas lições aprendidas durante o desenvolvimento foi proposto um modelo de planejamento estratégico orientado à promoção de BPM. / Business process management (BPM) has the potential to enhance performance for organizations of different sizes, industries, geographical locations or maturity levels of process management. One critical success factor for the promotion of BPM is its alignment with strategic planning. This research aims to explore the potential benefits of aligning the strategic planning process with a BPM program. Thus, the research question is defined as: what are the benefits of executing a diagnosis and strategic planning before a BPM program in a clinical research center (CRC)? The objective of the research is to define and execute steps of a strategic planning process in a clinical research center, identifying the benefits of these activities for a subsequent BPM program. Action-research was the method applied. The main findings were that the initial diagnosis of the organization in focus\' management practices and structuring of the strategic planning process ware adequate to prepare for the first cycle of a BPM program. Based on lessons learned along the research, a model was proposed for the strategic planning process oriented towards the promotion of BPM.

This study explores Working from Home (WFH) as a model of work in a public organisation in London, which operates in the clinical-trials sector. It argues that WFH is used as a strategy that offers benefits both to the organisation and its employees. WFH is offered to all Clinical Research Associates (CRAs) who work as monitors of the whole process of a clinical trial. Based on a qualitative approach, using semi-structured interviews of 29 CRAs, managers and administrative staff and secondary data, this single-case study focuses on five topics that are part of the CRAs’ everyday life. These are work-life balance (WLB), cost reduction, the Information and Communications Technology (ICT) factor, the performance of the CRAs and the management of remote workers. In particular, the study identified that WFH had a positive effect on CRAs’ WLB. Moreover, it argues that WFH may offer significant assistance to organisational budgets and may reduce personal expenses. It found that existing ICT could cover all employees’ technological needs and reduce the requirement of managers to keep them physically present at a centralised workplace. Additionally, this thesis also identified that WFH improved CRAs’ performance, whilst it also highlighted that results-oriented management was the main managerial approach towards employees who work from a distance. The key contribution of the thesis is the examination of the CRA occupation through a contemporary perspective on the WFH phenomenon.