Análise de Dados no Desenvolvimento Clínico de Medicamentos Experimentais: conceitos e aplicação
Código
21250
Unidade Orgânica
Faculdade de Ciências Médicas
Créditos
4,5
Professor responsável
Nancy Anne Lass
Língua de ensino
Inglês
Objectivos
Students will have the opportunity to become knowledgeable about aspects of study design, data collection, data analysis and reporting in drug development including:
- Goals of Phase I IV studies in the drug development process
- Achieving study objectives within the limits of the FDA regulations and ICH guidelines
- Specific issues in drug development, such as design of oncology studies, special populations, current standards of therapy and others
- Students will also have the opportunity to apply learnings through case-based assignments, designed to demonstrate real-life application to clinical drug development
Pré-requisitos
Os exigidos para a frequência de um programa de mestrado da Faculdade de Ciências Médicas.
Conteúdo
In this course, students will examine the process of planning, collecting, analyzing, and reporting data from drug development studies. The focus is on the goals of each phase (I-IV) of the clinical drug development process and how to achieve these objectives within the confines of the FDA regulations and ICH guidelines. In addition, students will consider requirements in other countries, including the UK Data Protection Act, issues related to the differences between the development of drugs for oncologic or AIDS indications compared to traditional drugs, cultural influences, current standards of therapy, the need for validated tools, and failure analyses.
Bibliografia
- Wang D and Bakhai A. Clinical Trials A Practical Guide to Design, Analysis and Reporting. Chicago: Remedica Publishing, 2006 (ISBN-10: 1-901-34672-2)
(ISBN-13: 978-1901346725)
Textbooks can be purchased through:
- www.amazon.com
- www.campusi.com
Optional textbooks for your personal library may include:
- Friedman, Furberg and DeMets: Fundamentals of Clinical Trials
- Pocock: Clinical Trials: A Practical Approach
- OGrady and Joubert: Handbook of Phase I/II Clinical Drug Trials
- Petrie and Sabin: Medical Statistics at a Glance
Método de ensino
Palestras presenciais intensivas e workshops
Método de avaliação
Apresentação e discussão de um protocolo de investigação, exames.