Avaliação de simuladores aplicados à síntese de tecidos junto a alunos de medicina veterinária / Comparison of simulators for tissue suture training by Veterinary Medicine students

O presente estudo avaliou a efetividade de simulador de sutura de silicone frente ao modelo usual em feltro e bastidor no desenvolvimento da habilidade em síntese cirúrgica. Vinte e seis alunos de Medicina Veterinária, sem vivência cirúrgica, foram distribuídos em dois grupos: o primeiro utilizou modelo de simulador em silicone e o segundo o simulador em bastidor e feltro. Em três encontros foram abordados conceitos sobre síntese, tipos de sutura e treinamento prático. Para avaliar sua experiência e percepções, os alunos responderam a um questionário e foram avaliados pelos professores na confecção dos padrões de sutura. Na avaliação do questionário, o simulador em silicone foi superior em sete das 10 questões. Na avaliação dos docentes, não houve diferença entre os grupos. Concluímos que ambos os modelos foram efetivos no desenvolvimento da habilidade cirúrgica, porém, a aceitabilidade dos alunos foi superior no modelo inovador.

This study compared the efficiency of a novel silicone model to a traditional low-fidelity method on the acquisition of surgical synthesis skills. Twenty-six veterinary students with no prior surgical training were randomly allocated into two groups: the first used a novel silicon model and second trained on a traditional set up. During three sessions, subjects such as synthesis, suture patterns, and suture practice were discussed. In order to assess the students experiences and perceptions, a questionary was applied. Students were also evaluated by teachers who scored their suture patterns. The questionary showed that the silicone model was superior in 7 out of 10 questions. No significant differences were detected between groups on the assessment by the teachers. This study shows that either model is effective for the development of suture skills. Nonetheless, the novel silicone model tested here has better acceptability when compared with the traditional model.

Avaliação de simuladores aplicados à síntese de tecidos junto a alunos de medicina veterinária / Comparison of simulators for tissue suture training by Veterinary Medicine students

O presente estudo avaliou a efetividade de simulador de sutura de silicone frente ao modelo usual em feltro e bastidor no desenvolvimento da habilidade em síntese cirúrgica. Vinte e seis alunos de Medicina Veterinária, sem vivência cirúrgica, foram distribuídos em dois grupos: o primeiro utilizou modelo de simulador em silicone e o segundo o simulador em bastidor e feltro. Em três encontros foram abordados conceitos sobre síntese, tipos de sutura e treinamento prático. Para avaliar sua experiência e percepções, os alunos responderam a um questionário e foram avaliados pelos professores na confecção dos padrões de sutura. Na avaliação do questionário, o simulador em silicone foi superior em sete das 10 questões. Na avaliação dos docentes, não houve diferença entre os grupos. Concluímos que ambos os modelos foram efetivos no desenvolvimento da habilidade cirúrgica, porém, a aceitabilidade dos alunos foi superior no modelo inovador.(AU)

This study compared the efficiency of a novel silicone model to a traditional low-fidelity method on the acquisition of surgical synthesis skills. Twenty-six veterinary students with no prior surgical training were randomly allocated into two groups: the first used a novel silicon model and second trained on a traditional set up. During three sessions, subjects such as synthesis, suture patterns, and suture practice were discussed. In order to assess the students experiences and perceptions, a questionary was applied. Students were also evaluated by teachers who scored their suture patterns. The questionary showed that the silicone model was superior in 7 out of 10 questions. No significant differences were detected between groups on the assessment by the teachers. This study shows that either model is effective for the development of suture skills. Nonetheless, the novel silicone model tested here has better acceptability when compared with the traditional model.(AU)

Clinical trials sponsored by industry and other private organizations.

The present manuscript discussed some relevant aspects related to private sponsored clinical trials in dentistry. For decades, the academy has been the major responsible for research in Brazil. Distant from the trade sector, academic research has not always provided clear benefits to society. A key aspect of making benefits clearer is the process of scientific knowledge transference to decision-makers, which is, in fact, the ground of evidence-based dentistry. Although private sponsoring of clinical research seems to be part of the research progress of the business rates, investment in Brazil is lower than those observed in other countries. It is particularly important to understand that instead of creating its own rules, dentistry imported the high-quality standards originally designed for pharmaceutical studies. Therefore, it is critical to understand the original rules and how dental items are classified by regulatory agencies. In fact, knowledge about international and local regulation is a basic assumption in industry-sponsored research. Despite globalization, the identification of industry-sponsored studies through open access databases is still very hard and time-demanding. A common concern when conducting industry-sponsored trials is study biases. Fortunately, many relevant organizations, academic and industry groups, have been working seriously against that. Finally, for less experienced researchers, many aspects related to industry-sponsored studies - such as confidentiality, authorship, budget - are deeply discussed until a final version of the trial agreement can be written and signed, protecting all sides. In short, the scenario should be improved, but it already represents a nice opportunity for dental research.

Clinical trials sponsored by industry and other private organizations

Abstract The present manuscript discussed some relevant aspects related to private sponsored clinical trials in dentistry. For decades, the academy has been the major responsible for research in Brazil. Distant from the trade sector, academic research has not always provided clear benefits to society. A key aspect of making benefits clearer is the process of scientific knowledge transference to decision-makers, which is, in fact, the ground of evidence-based dentistry. Although private sponsoring of clinical research seems to be part of the research progress of the business rates, investment in Brazil is lower than those observed in other countries. It is particularly important to understand that instead of creating its own rules, dentistry imported the high-quality standards originally designed for pharmaceutical studies. Therefore, it is critical to understand the original rules and how dental items are classified by regulatory agencies. In fact, knowledge about international and local regulation is a basic assumption in industry-sponsored research. Despite globalization, the identification of industry-sponsored studies through open access databases is still very hard and time-demanding. A common concern when conducting industry-sponsored trials is study biases. Fortunately, many relevant organizations, academic and industry groups, have been working seriously against that. Finally, for less experienced researchers, many aspects related to industry-sponsored studies - such as confidentiality, authorship, budget - are deeply discussed until a final version of the trial agreement can be written and signed, protecting all sides. In short, the scenario should be improved, but it already represents a nice opportunity for dental research.

O contexto atual da pesquisa clínica nas indústrias e faculdades de Medicina Veterinária do Estado de São Paulo, Brasil / The current context of clinical research in industries and schools of Veterinary Medicine in São Paulo State, Brazil

O mercado farmacêutico veterinário do Brasil é considerado um dos maiores do mundo e está em expansão. A pesquisa clínica é uma etapa importante para o desenvolvimento de produtos veterinários, no entanto, informações sobre essas atividades nas indústrias, fazendas experimentais terceirizadas e faculdades de Medicina Veterinária são escassas. Neste contexto, são descritas as atividades de pesquisa clínica nessas instituições do Estado de São Paulo. Para tanto, foram enviados questionários a representantes das indústrias farmacêuticas veterinárias e das faculdades de Medicina Veterinária do Estado. Os resultados mostraram que a maioria das indústrias tem seus escritórios na cidade de São Paulo, que em 2016 a maioria delas patrocinou entre 11 e 20 estudos, muitos deles em parceria com as faculdades. Todas as indústrias participantes já contrataram serviços de Contract Research Organization (CRO), embora relatem insatisfações com os mesmos. Por outro lado, representantes das faculdades de Medicina Veterinária declararam, em sua maioria, que conduziram dez desses estudos no ano de 2016, muitos deles com patrocínio das indústrias. Já estas se ressentem da falta de agilidade e compromisso das faculdades. A aproximação entre as indústrias de produtos veterinários e as faculdades de Medicina Veterinária foi vista pelos representantes tanto das faculdades quanto das indústrias como benéfica.

The Brazilian veterinary pharmaceutical market is considered one of the largest in the world and is in expansion. Clinical research is a crucial step in the development of veterinary products, however, information on these activities in industries, experimental farms and veterinary undergraduate courses are scarce. Given this context, this study intended to describe clinical research activities in these institutions in the state of São Paulo. For such, we sent a questionnaire to the representatives of pharmaceutical industries and institutions of veterinary medicine of the state. The results showed that the offices of most industries are located in the city of São Paulo. In 2016, most of these companies sponsored between 11 and 20 studies, many of them in partnership with departments of veterinary medicine. All industry participants contracted Contract Research Organization (CRO) services, despite reporting dissatisfaction with these services. On the other hand, most representatives from veterinary medicine courses reported that they performed 10 studies in 2016, many of them sponsored by industries. The industries resent the lack of agility and commitment of the institutions. The approximation between the veterinary industry and veterinary medicine courses was seen by representatives of both as beneficial.

O contexto atual da pesquisa clínica nas indústrias e faculdades de Medicina Veterinária do Estado de São Paulo, Brasil / The current context of clinical research in industries and schools of Veterinary Medicine in São Paulo State, Brazil

O mercado farmacêutico veterinário do Brasil é considerado um dos maiores do mundo e está em expansão. A pesquisa clínica é uma etapa importante para o desenvolvimento de produtos veterinários, no entanto, informações sobre essas atividades nas indústrias, fazendas experimentais terceirizadas e faculdades de Medicina Veterinária são escassas. Neste contexto, são descritas as atividades de pesquisa clínica nessas instituições do Estado de São Paulo. Para tanto, foram enviados questionários a representantes das indústrias farmacêuticas veterinárias e das faculdades de Medicina Veterinária do Estado. Os resultados mostraram que a maioria das indústrias tem seus escritórios na cidade de São Paulo, que em 2016 a maioria delas patrocinou entre 11 e 20 estudos, muitos deles em parceria com as faculdades. Todas as indústrias participantes já contrataram serviços de Contract Research Organization (CRO), embora relatem insatisfações com os mesmos. Por outro lado, representantes das faculdades de Medicina Veterinária declararam, em sua maioria, que conduziram dez desses estudos no ano de 2016, muitos deles com patrocínio das indústrias. Já estas se ressentem da falta de agilidade e compromisso das faculdades. A aproximação entre as indústrias de produtos veterinários e as faculdades de Medicina Veterinária foi vista pelos representantes tanto das faculdades quanto das indústrias como benéfica.(AU)

The Brazilian veterinary pharmaceutical market is considered one of the largest in the world and is in expansion. Clinical research is a crucial step in the development of veterinary products, however, information on these activities in industries, experimental farms and veterinary undergraduate courses are scarce. Given this context, this study intended to describe clinical research activities in these institutions in the state of São Paulo. For such, we sent a questionnaire to the representatives of pharmaceutical industries and institutions of veterinary medicine of the state. The results showed that the offices of most industries are located in the city of São Paulo. In 2016, most of these companies sponsored between 11 and 20 studies, many of them in partnership with departments of veterinary medicine. All industry participants contracted Contract Research Organization (CRO) services, despite reporting dissatisfaction with these services. On the other hand, most representatives from veterinary medicine courses reported that they performed 10 studies in 2016, many of them sponsored by industries. The industries resent the lack of agility and commitment of the institutions. The approximation between the veterinary industry and veterinary medicine courses was seen by representatives of both as beneficial.(AU)

Pesquisa clínica em periodontia: princípios metodológicos e aspectos éticos / Clinical research in periodontics: methodological principles and ethical issues

O número de publicações em periodontia aumentou consideravelmente nas últimas décadas. Entretanto, uma importante proporção dos estudos clínicos recentemente publicados nacional e internacionalmente ainda apresenta erros metodológicos que afetam a sua validade. O objetivo desse artigo é apresentar princípios metodológicos que devem ser observados durante o planejamento e execução de estudos clínicos em Periodontia. Adicionalmente, aspectos éticos e de normatização serão discutidos visando garantir a integridade das evidências clínicas geradas.