Clinical Trials

Code: CMS13755I

3 ECTS

Duration: 15 weeks/78 hours

Scientific Area: Ciências Farmacêuticas

Teaching languages: Portuguese

Languages of tutoring support: Portuguese

Presentation

The UC aims to provide students with the acquisition of knowledge and skills in the field of clinical trials, their importance and evolution, as well as the different types / designs, organization and legal and regulatory framework of clinical trials, at national and European level.

Sustainable Development Goals

Saúde de qualidade - Assegurar uma vida saudável e promover o bem-estar para todos, em todas as idades.

Educação de qualidade - Assegurar a educação inclusiva, e equitativa e de qualidade, e promover oportunidades de aprendizagem ao longo da vida para todos.

Learning Goals

At the end of the curricular unit, students should have acquired knowledge about human experimentation throughout history, its importance for discovering new drugs, and the evolution of ethical principles that govern a clinical trial.
They should also be able to express themselves with the appropriate language and terms applicable to clinical trials.
The general objectives are:
1.Know and distinguish the different types / designs of clinical trials
2.Know how to organize a clinical trial and who are the main stakeholders.
3.Know the legal and regulatory framework of a clinical trial at national and European level.
4.Have critical analysis capacity in relation to published clinical trials.

1.Historical aspects of clinical trials
2.Ethical aspects of clinical trials
3.Types of clinical trials
4.Organization of a clinical trial - patient recruitment, informed consent, randomization in clinical trials, validation of a clinical trial, instruments for assessing efficacy and safety
5.National and European legislation and ICH standards for clinical trials. Namely the Regulation (EU) No 536/2014 of the European Parliament and of the Council
6.Main intervenients in a clinical trial and their respective roles and responsibilities (researcher, sponsor, trial centres, CROs, competent authorities, ethical commission).

Teaching Methods

Teaching/learning takes place through integrating: i) theoretical classes using expository methods and active pedagogy; ii) theoretical-practical classes with discussion of scientific articles and seminars with the intervention of different players in clinical trials, and critical discussion of cases.

Assessment

The practical evaluation will be based on a group presentation of a critical analysis of a clinical trial published in the last two years (40% of the final evaluation) and the evaluation of the theoretical content will be carried out through a final written exam (60% of the final evaluation).