Avaliação de ensaios clínicos no Brasil: histórico e atualidades / Evaluation of clinical trials in Brazil: history and current events / Evaluación de ensayos clínicos en Brasil: historia y actualidad

Resumo Ensaios clínicos devem ser aprovados e acompanhados por autoridades éticas e regulatórias para garantir que a conduta ética e os aspectos técnicos das pesquisas estejam em conformidade com os padrões exigidos. O conhecimento desse processo é primordial para que estudos sejam delineados e conduzidos de acordo com os padrões aplicáveis, sendo parte essencial para a capacitação técnica e científica nacional. No Brasil, a avaliação dos estudos é realizada pelos comitês de ética em pesquisa, pela Comissão Nacional de Ética em Pesquisa e pela Agência Nacional de Vigilância Sanitária. Pesquisadores e patrocinadores alegam que o tempo para aprovação e início de ensaios clínicos limita novos estudos. No entanto, as normas brasileiras estão em contínuo aperfeiçoamento, o que demonstra interesse e capacidade em aprimorar os trâmites, sem perder a qualidade na avaliação ética.

Abstract Clinical trials must be approved and monitored by ethical and regulatory authorities to ensure that the ethical conduct and technical aspects of the research are in compliance with required standards. The in-depth understanding of this process is crucial for studies to be delineated and conducted in accordance with applicable standards, being an essential part of national technical and scientific training. The evaluation of the studies in Brazil is performed by the research ethics committees, by the National Research Ethics Commission and by the Brazilian regulatory agency, the Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency). Researchers and sponsors claim that the time taken for approval and initiation of clinical trials limits further studies. However, Brazilian standards are constantly improving, demonstrating the interest and ability to improve procedures, without losing quality in ethical evaluation.

Resumen Los ensayos clínicos deben ser aprobados y acompañados por autoridades reguladoras y éticas con el fin de garantizar que la conducta ética y los aspectos técnicos de las investigaciones cumplan con los estándares exigidos. El conocimiento de este proceso es fundamental para que los estudios sean delineados y conducidos de acuerdo con los estándares aplicables, siendo una parte esencial para la capacitación técnica y científica nacional. En Brasil, la evaluación de los estudios es realizada por los Comités de Ética en Investigación, la Comisión Nacional de Ética en Investigación y por la agencia reguladora nacional, la Agencia Nacional de Vigilancia Sanitaria. Los investigadores y patrocinadores sostienen que el tiempo para la aprobación y el inicio de ensayos clínicos es un factor limitante para nuevos estudios. No obstante, las normas brasileñas están en continuo perfeccionamiento, lo que demuestra el interés y la capacidad para mejorar los trámites, sin perder calidad en la evaluación ética.

Effects of different biotic substrata on mussel attachment.

Surface colonization by invertebrates can be stimulated or inhibited by cues produced by biofilms, conspecifics or other macroorganisms. To study the effects of living substrata on the attachment of the brown mussel, Perna perna, two different approaches were employed: (1) mussels were distributed in sets of Petri dishes consisting of one sterile set (controls), three sets in which marine biofilms were allowed to develop in aquaria for 1, 7 or 15 days and another set that had been immersed in a natural marine environment for 1-day. There was no significant effect of biofilms on attachment, suggesting that neither age nor the source of the biofilm influenced attachment. (2) Mussels were suspended over PVC panels (controls) and over panels on which Balanus trigonus (Crustacea), Schizoporella errata (Bryozoa), Symplegma rubra or Didemnum speciosum (Ascidiacea) were present. Attachment was significantly higher on the controls and on B. trigonus than on colonial taxa such as S. rubra, S. errata and D. speciosum, probably due to antifouling defenses of these species. The results show that the composition of the biological substratum is an important factor affecting mussel behavior.