Clinical Trials II

Recommended Prerequisites

All courses in the LFB are important for understanding the subjects taught in classes. Physiopathology, pharmacology and clinical trials I are relevant, as well as to know how to consult clinical trial guidelines, and how to interpret clinical trials protocols, study reports and articles.

Teaching Methods

Each topic is explaned in lectures the masterful type, but with great interaction with students. The theoretical component evaluation is performed at the end of the semester, through a final exam. The practical component evaluation if performed by presentation of a group work. In addition, attendance to practical classes is

Learning Outcomes

The students had to know the fundamental principles of clinical trials and to analyse clinical trials of the most prevalent diseases.
-    Knowledge: knowing the fundamental principles for a clinical trial of the most prevalent diseases can be considered robust.
-    Skills: must have critical thinking about the publications of clinical trials of the studied diseases. To be able to apply several tools to analyse and interpret clinical trials.
-    Attitudes: searching the necessary tools (clinical investigation guidelines, tools to evaluate methodological quality) that led to use, in adequate way, individually or in groups, all the human and technological resources available for learning in this area.

Work Placement(s)

No

Syllabus

General concepts of clinical trials and evaluation of methodological quality of clinical trials (review); Clinical trials in special populations (geriatrics and pediatrics);
Clinical trials in most prevalent diseases: clinical trials design and selection of endpoints and population in all clinical investigation phases;
Search of clinical trials (clinical investigation guidelines, clinical practice guidance);
Analysis of clinical trials in most prevalent diseases according to guidance and evaluation of methodological quality: presentation of students

Head Lecturer(s)

Ana Sofia Martins Penedones

Assessment Methods

Assessment
Synthesis work: 25.0%
Exam: 75.0%

Bibliography

Lei n.º 21/2014, de 16 de abril
Regulamento n.º 536/2014, do Parlamento Europeu e do Conselho, de 16 de abril
Eudralex - Volume X
Normas/ Guidelines da EMA (www.ema.europa.pt)