Optimização da Metodologia de Ensaios Clínicos e Resolução de Problemas
Código
21247
Unidade Orgânica
Faculdade de Ciências Médicas
Departamento
Gabinete de Estudos Pós-Graduados
Créditos
4,5
Professor responsável
Maria C. Mancini
Língua de ensino
Inglês
Objectivos
Course is designed to familiarize students with clinical trials, including design, conduct, analysis and interpretation of clinical trial results. After completion of the course, students should be able to:
- Apply basic principles to design a clinical trial;
- Determine sample sizes for trials of simple designs
- Identify the basic ethical principles that should guide the design of clinical trials, apply them in the design of a clinical trial, and use them to critique the design of others,
- Demonstrate knowledge of specific types of designs of practical and historical interest including dose-finding, safety & efficacy and comparative trials;
- Understand the importance of design and its relation to the analysis of clinical trials
Pré-requisitos
Os exigidos para a frequência de um programa de mestrado da Faculdade de Ciências Médicas.
Conteúdo
Quantitative data analysis in the creation of dynamic drug-disease models, strategic market models, trial simulation models, and integrated financial models enable the analysis of key variables in development of clinical trials in real time. This integrated approach allows all decisions in the design to optimize value against both scientific and business criteria simultaneously and continuously. Students will learn to take a complete view of the development process at the outset - across time, across the portfolio, and at all levels in the organization. This allows for greater insight into a drug's potential early in the development process and leads to a more focused development program for promising compounds, including an optimized clinical trial design. It also allows for earlier cessation of unpromising clinical trials, saving development time and funds.
Bibliografia
- Clinical Trials: A Methodologic Perspective, Wiley Publishing, 2nd edition
- Beth Dawson & Robert Trapp, Basic & Clinical Biostatistics, McGraw-Hill Medical (2004), ISBN: 978-0071410175
- Leon Gordis, Epidemiology: Student CONSULT Online Access, Saunders Publishing (2008), ISBN: 978-1416040026
Método de ensino
Palestras e workshops
Método de avaliação
Apresentação e discussão de um protocolo de investigação, exames.