Ensaios Clínicos Internacionais Multicêntricos
Código
21253
Unidade Orgânica
Faculdade de Ciências Médicas
Créditos
4,5
Professor responsável
William L. Tobia
Língua de ensino
Inglês
Objectivos
This course presents students with the opportunity to study the considerations required to initiate and maintain regulatory-compliant international trials across multiple geographies. Through case study reviews and group projects, students will examine strategies to integrate all participating countries along common protocols and deadlines.
The course aims for an understanding of what Good Clinical Practices (GCP) require when conducted in an international context.
Pré-requisitos
Os exigidos para a frequência de um programa de mestrado da Faculdade de Ciências Médicas.
(Esta unidade curricular também pode ser frequentada no 1º ano do ciclo de estudos).
Conteúdo
This course will focus on initiating, managing, amending, and collecting data from multi-center, multi-country clinical trials. The course begins by surveying the growing internationalization of clinical research of new drugs, devices, and biologics.
In the current new drug environment, for example, even trials carried out under the aegis of a US-FDA Investigational New Drug Application (IND) are increasingly likely to involve investigators in the EU, Brazil, Russia, India, or China.
The global nature of this research is in part due to the advantages that certain countries offer for clinical researchers, including lower costs, flexible health care infrastructures, and the presence of treatment-naïve populations.
Multi-source studies, however, present their own practical, methodological, legal, and ethical challenges.
Bibliografia
- Clinical Trials: A Methodologic Perspective Second Edition(Wiley Series in Probability and Statistics) - Hardcover (Aug 1, 2005) by Steven Piantadosi
- Friedman, Furberg and DeMets: Fundamentals of Clinical Trials
- Pocock: Clinical Trials: A Practical Approach
Método de ensino
Palestras de ensino a distancia e workshops
Método de avaliação
Apresentação e discussão de um protocolo de investigação, exames.