Clinical Trials II

Recommended Prerequisites

Physiology, Physiopathology and Pharmarmacology and specific training in clinical trials for the most prevalent diseases and risk factors. Knowing consult databases for guidance of clinical trials.

Teaching Methods

Each topic is explained in lectures the masterful type , but with great interaction with students .
The evaluation was conducted at the end of the semester, through final exam for the theoretical part .
The attendance at lectures is optional but there will be appreciation of the presence and collaboration ( continuous assessment) .
Attendance to practical classes is compulsory , students must attend at least 2/3 of lectured. Each topic is explained in practical classes and an application of theoretical concepts .

Learning Outcomes

Knowledge: Knowing the fundamental characteristics for a clinical trial can be considered robust. You must be able to describe an exploratory, explanatory or pragmatic clinical trial. You should know how to make monitoring a clinical trial.
Skills: Must have critical thinking about the publications of clinical trials. You should be able to apply the various scales for analysis of a clinical trial.
Attitudes: Information Research leading to use, an adequate form, individually or in groups, all the human and technological resources available for learning in this area.

Work Placement(s)

No

Syllabus

Search the guiding documents for clinical trials.
General concepts of clinical trials (review);
Pharmacogenomics and clinical trials.
And pharmacoeconomics in clinical trials.
Study patients subgroups; Use of a composite score.
Clinical trials to study fixed combinations and bioequivalence.
Studies of non-inferiority, therapeutic equivalence and superiority.
Clinical trials for control of risk factors (hypertension and dyslipidaemia), and for treatment of common pathologies (cancer, diabetes mellitus, asthma, COPD, osteoporosis)
EudraLex - vol. 10: Presentation of students with discussion and evaluation
Data protection and integrity of clinical research - Lecture
Translation and cultural adaptation of measuring instruments - Lecture
Presentation of scientific articles in accordance with the evaluation criteria of a clinical trial protocol. .
Law No. 12/2005 of 26 January and Law No. 131/2014 of 29 August on genetic information and personal health information.

Head Lecturer(s)

Ana Sofia Martins Penedones

Assessment Methods

Assessment
Mini Tests: 15.0%
Other: 15.0%
Exam: 70.0%

Bibliography

-Tom Brody. Clinical Trials. Academic Press, 1st edition, 2012-Richard Chin & Bruce Y. Lee. Principles and Practice of Clinical Trials Medicine, Elsevier, 2008
- Normas / Guidelines da EMA (www.ema.europa.eu)
- Directiva 2005/28/CE da CE de 8 Abril 2005
- Lei n.º 21/2014 de 16 de Abril de 2014 – Lei da investigação clínica
- Lei que cria as Comissões de Ética para a Saúde (CES) – Decreto Lei nº 97/95.
- Lei da Protecção de Dados Pessoais – Decreto lei nº 67/98 - transpõe para a ordem jurídica nacional a Directiva nº 95/46/CE.
- Lei que cria a Comissão de Ética para a Investigação Clínica (CEIC) – Portaria nº57/2005
- Directiva 2005/28/CE de 8 de Abril.
-EudraLex - Volume 10 - Clinical trials guidelines
- Declaração de Helsinquia de 2013.