Submitted by Fabiana Gonçalves Pinto (benf@ndc.uff.br) on 2015-12-02T19:00:17Z No. of bitstreams: 1 Cristiane Damasceno de Oliveira Chalita.pdf: 1554570 bytes, checksum: b0a9525909da6d60b1d5c83ed5f21fd8 (MD5) / Made available in DSpace on 2015-12-02T19:00:17Z (GMT). No. of bitstreams: 1 Cristiane Damasceno de Oliveira Chalita.pdf: 1554570 bytes, checksum: b0a9525909da6d60b1d5c83ed5f21fd8 (MD5) Previous issue date: 2013 / Mestrado Acadêmico em Ciências do Cuidado em Saúde / O Estudo refere-se à discussão da atuação dos coordenadores de ensaio clínico, voltada para suas competências profissionais. Teve como objetivos: Identificar o perfil dos profissionais que atuam como coordenadores de ensaios clínicos; Descrever as atividades que os coordenadores de ensaios clínicos desenvolvem; Elencar as competências dos coordenadores de ensaios clínicos para realizarem suas atividades. Tratou-se de uma pesquisa qualitativa descritiva exploratória do tipo estudo de caso, realizada com 13 coordenadores de Ensaio Clínico dos Centros de Pesquisa Clínica do INCA e do HUAP. A coleta de dado deu-se através de entrevistas semi-estruturadas e questionário sócio-demográfico. Os dados obtidos foram transcritos, formatados e analisados através do software Alceste, que decompôs o texto em unidades menores que foram dividas em quatro classes, integradas em duas categorias, na qual uma aborda questões relacionadas ao desenvolvimento do trabalho do coordenado e a outra aborda questões específicas dessa profissional. Os resultados apontaram que esses profissionais são em sua maioria mulheres que possuem formação superior em enfermagem. Dentre todas as atividades, destacou-se as assistenciais juntamente com a preocupação da garantia do tratamento integral dos sujeitos, salientando a gestão do cuidado na prática desse profissional. Em relação ao perfil de competências, foram evidenciadas como necessárias para o desenvolvimento eficaz do trabalho do CEC a negociação, a atenção à saúde, a comunicação, a administração e a tomada de decisão, competências essas fundamentas pelo saber fazer desses profissionais. Através da maior valorização do conhecimento, das habilidades e atitudes desses profissionais, visando identificar pessoas com maior potencial de crescimento, flexibilidade e pensamento estratégico, fica garantido o maior sucesso no desenvolvimento dos protocolos de Pesquisa Clínica e consequentemente maior sucesso no avança científico da saúde do País. / The study refers to practice of coordinator clinical research focused on their professional skills. Objectives: Identify the profile of coordinator clinical research; Describe the activities that coordinators develop; List the skills of coordinators clinical research to conduct their activities. This was an exploratory descriptive qualitative research case study type, performed 13 coordinators Centres of Clinical Research INCA and HUAP. The collection of data was made through semi-structured interviews and questionnaire socio-demographic. The data were transcribed, analyzed and formatted to Alceste software, this software decompose the text in smaller units that were divided into four classes, Integrated into two categories, one addresses issues related to the development of the coordinators work of the other addresses specific issues this professional. The results showed that these professionals are mostly women who have a graduation in nursing. Among all the activities, stood out assistance activities along with the concern of ensuring integral treatment of the subject emphasizing the managed care practice these professional. Were found this skills: negotiation, attention health, communication, administration and decision-making, supported by professional practice. Through greater appreciation of knowledge, skills and attitudes to identify people with potential greater growth, flexibility and strategic thinking is guaranteed greater success in the development of Clinical Research Protocols and hence most successful scientific advances in the health of the country.

This master thesis was done at Uppsala Clinical Research Center (UCR). UCR have recently developed the technical platform QReg 5 for managing quality registries. UCR have been in contact with several international organizations interested in collaborating with UCR because of their expertise within quality registries as well as their technical competence. UCR have a complicated owner structure as well as organizational structure, as they are owned by Uppsala University and Uppsala County Council. The purpose of this master thesis was to present how QReg 5 could be commercialized under UCR's preconditions. In order for the internationalization plans to be successful, it was shown that the shared ownership of UCR needs to become clearer. By taking advantage of the possibilities with the new development section at UCR, the management of the contacts will be more efficient. Potential competitors for UCR are registry centers that have created their own technical solutions, large software companies, Life Science related organizations (e.g. hospitals), the organizations that UCR license QReg 5 to, as well as software companies creating electronic medical records. The most interesting customer segment for UCR are organizations with technical competences, which are placed in countries were quality registries are not yet in use.

A pesquisa clínica patrocinada no Brasil vem crescendo cada vez mais e gerando conhecimento científico em diversas áreas da saúde. O desenvolvimento desses ensaios clínicos envolve aspectos que vão além da geração de fármacos e produtos mais avançados. O grande alicerce da pesquisa clínica está também nos pacientes que aceitam participar de um estudo científico. Estes precisam passar por um processo de consentimento que envolve ter conhecimento sobre todos os aspectos que envolvem a sua participação no ensaio clínico. Dentro desse contexto, surge um grande desafio na área que é como realizar o processo de consentimento de maneira adequada. É preciso levar em consideração aspectos como compreensão, motivações, influências, coerção, benefícios, riscos, entre outros aspectos. O objetivo deste trabalho foi identificar quais os fatores vivenciados pelos participantes de pesquisa clínica durante o processo de consentimento. Foram aplicados questionários a respeito da sua percepção no que envolve a participação na pesquisa clínica. Com os dados gerados foi possível desenvolver um conjunto de recomendações visando o aprimoramento do processo de consentimento em projetos de pesquisa clínica. / Clinical research sponsored in Brazil has been increasing and generating scientific knowledge in several areas of health. The development of these clinical trials involves aspects that go beyond the generation of drugs and more advanced products. The key of clinical research is also in patients who accept to participate in a scientific study. These need to undergo a consent process that involves having knowledge about all aspects that involve their participation in the clinical trial. Within this context, a great challenge arises in the area that is how to carry out the consent process in an appropriate way. It is necessary to take into account aspects such as understanding, motivations, influences, coercion, benefits, risks, among other aspects. The objective of this study was to identify the factors experienced by clinical research participants during the consent process. Questionnaires were applied regarding their perception regarding the participation in clinical research. With the data generated, it was possible to develop a set of recommendations aimed at improving the consent process in clinical research projects.

This thesis examines patient recruitment in clinical trials. It is a current and pressing issue, which is not sufficiently embedded in the thinking of doctors and patients, their patterns of communication, and more broadly in the traditional doctor-patient relationship, which continues to be burdened by post-socialist paternalism. The formal framework and ethics have been developed relatively recently, and their application causes confusion to all participants regarding how to proceed in specific situations. In addition, the choice of topic, and especially the form of dealing with the topic, was motivated by the relative lack of academic resources and publications in the field. The theoretical section of the thesis defines clinical research and its phases, and introduces basic terminology and documents closely linked to clinical research. In addition, it focuses on research ethics, thoroughly examining the issue of informed consent - a fundamental document necessary for recruiting a patient in a clinical trial. Finally, one chapter of the thesis focuses on the issue of medical literacy, the level of which is integral to the participants' understanding of the importance of clinical research, and directly affects participants' decision-making. The empirical section is divided into two parts. The...

Background: Therapeutic misunderstanding (TMU) and its three facets: therapeutic misconception, therapeutic misestimation, and therapeutic optimism have been identified as major challenges to the ethical conduct of clinical research and obtaining informed consent from research participants. However, the prevalence of TMU among clinicians and researchers has not been explored. Since most physicians will be exposed to clinical research over the course of their career, the understanding of clinical research procedures is important. In this study we attempted to determine the prevalence of TMU among medical students: future clinicians. Methods: Twenty-two BUSM undergraduate medical students took part in a two-part, survey evaluating the prevalence of therapeutic misunderstanding using "The Therapeutic Misunderstanding Scale". The attitudes of the students towards increasing the exposure to clinical research topics through the medical school curriculum were also determined. Results: The majority of the medical students exhibited therapeutic misunderstanding, particularly in the area of therapeutic misconception. In particular, the misunderstanding the difference between evidence-based clinical care versus hypothesis driven clinical research was exhibited. Although there was strong agreement that education in clinical research and clinical research ethics was important, the participants though increases of clinical research topics in the curriculum was not needed. Conclusions: The increased prevalence of TMU among future physicians underscores the need to teach clinical research and research ethics. Further research on a larger sample needed to validate the findings.

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BACKGROUND: Neurodevelopment and growth are primary concerns when neonates are born extremely premature (between 23 and 28 weeks gestation). The focus of the PENUT Trial is to administer erythropoietin (Epo) to extremely preterm infants and to study the potential neuroprotective effects of Epo. The PENUT ethics survey was designed to provide study investigators with parental feedback regarding the consent process for the PENUT Trial and to improve the consent process for future research trials. OBJECTIVES: The objectives of this research thesis are to learn (1) what factors are important to parents who are approached for informed consent to include their infants in a research study and (2) how parents may be influenced by demographic and social factors. The hypothesis is that parents approached prenatally may be more likely to consider enrolling their infants into the PENUT Trial. METHODS: All parents approached to enroll their eligible infants into the PENUT Trial (both consenting and non-consenting parents) were eligible to complete the ethics survey. While completing the survey, parents (1) responded to statements about factors involved in their decision-making process, (2) rated their overall experiences in being asked to join the PENUT Trial, (3) described what ultimately led them to enroll or not to enroll their infants in the PENUT Trial, and (4) responded to demographic questions. RESULTS: Thirty mothers of infants eligible for the PENUT Trial (22 consenting, 8 non-consenting) were approached by a research study coordinator to complete the survey. Of the 22 consenting mothers, 10 were approached prenatally, and 12 were approached postnatally for the PENUT Trial. However, of the 8 non-consenting mothers, only 1 was approached prenatally, whereas 7 were approached postnatally for the PENUT Trial. The ethics survey was completed by 20 of 22 consenting mothers and 6 of 8 non-consenting mothers. The average rating among mothers of their overall experiences with the consenting process for the PENUT Trial was 3.77 (2.75 among non-consenters, 4.00 among consenters) on a scale of 1 (= poor) to 5 (= excellent). Thirteen mothers preferred to be approached for the PENUT Trial by their baby’s neonatologist (6 preferred their OB/GYN, 5 preferred another doctor, 1 preferred a study coordinator, and 10 had no preference). In addition, 14 mothers preferred that the person approaching them was involved in the research trial (5 preferred person not involved, 2 preferred to be approached by those involved and not involved, and 9 had no preference). Lastly, 18 mothers preferred to be approached prenatally (5 postnatally, and 7 had no preference). CONCLUSIONS: Preliminary findings from the PENUT Trial ethics survey support the hypothesis that mothers prefer to be approached prenatally when considering enrollment of their newborn infants into the PENUT Trial. Survey responses also suggest that during the consent process mothers prefer to be approached by either (1) two neonatologists, with one responsible for the baby’s care and the other responsible for the research trial, or (2) one neonatologist who is involved in both the baby’s care and the research trial.

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