Relatório de estágio curricular numa unidade de investigação clínica

• Autor(a) principal: Rodrigues, Raquel Filipa de Oliveira
• Data de Publicação: 2016
• Tipo de documento: Dissertação
• Idioma: eng
• Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
• Texto Completo: http://hdl.handle.net/10773/16575
• topic: Biomedicina farmacêutica; Investigação médica - Relatórios de estágio; Ensaios clínicos - Monitorização

This report presents the activities and projects developed during the curricular internship in a clinical research unit, the Laboratory of Clinical Pharmacology, part of the Institute of Molecular Medicine. The internship had a duration of 10 months, being that the most relevant activity was the coordination of clinical trials in the area of neurology. I also collaborated in medical writing activities, namely systematic reviews on cardiology, paediatrics and clinical pharmacology. I had also the opportunity to participate in the management of clinical databases, in the monitoring and coordination of observational studies and in pharmacovigilance activities. In the State-of-the-Art section is referred the process of Research and Development of new drugs and are characterized some aspects of clinical research in Portugal, namely the framework of the activity, with a focus in Neurology. Furthermore, the current context of Pharmacovigilance in the system of drug safety evaluation, in Portugal, is presented. This training period enabled me not only to put into practice the knowledge acquired at the University, but also expanding it. During this internship, I could closely observe the logistical difficulties that a research centre faces during the conduction of clinical trials. I also increased my knowledge in clinical research while expanding my areas of professional interest. I could improve my writing skills of scientific documents, through the elaboration of several systematic reviews and meta-analysis. I also realized the importance of clinical research units as well as the crucial role of clinical trial coordinators in the rigorous implementation of all the studies’ procedures and in the communication between team members. This specific training focused on clinical studies, namely phases II and III clinical trials and observational studies in neurodegenerative diseases. I supported the coordination of four studies in Familial Amyloidotic Polyneuropathy, two in Huntington's disease, two in Parkinson's disease, one in Alzheimer's disease and one in Idiopathic Cervical Dystonia. The contact with patients was a very important part of my experience in clinical trials coordination. I consider that this internship was a very enriching experience, where I started to perform clinical research activities. Thus, I finish the internship with motivation and interest to work in the area of clinical trials coordination and project management.