Clinical Trials: Methodology
Code
101208
Academic unit
NOVA Medical School | Faculdade de Ciências Médicas
Credits
3
Teacher in charge
Prof. Doutor Roberto José Palma dos Reis
Teaching language
Portuguese
Objectives
To know the main methods used in the design and development of clinical trials.
To acquire skills for the development of clinical trial protocols
To acquire skills that enable a critical interpretation of the results of published papers.
Prerequisites
Subject matter
The need for clinical trials The Evidence based Medicine
Basic methodology for clinical trials:
ndomization
Single or double Occultation
Basic Design: parallel and cross-sectional studies, single-centre and multicentre
Statistics adapted for clinical trials
Preparation of a clinical trial
Hypothesis
Study design
Sample size calculation
Protocol development
Objectives
Inclusion and exclusion criteria
The variables to be analysed
The Statistical Methods
Launching the clinical trial - choice of centres and researchers
Monitoring the trial
Collecting results
Treatment and analysis of data
Interpretation of results
Publication of results
Participants in a Clinical Trial
Sponsor (Company)
Promoter
Project leader
Researcher
Monitor
Patients
Other support for the clinical trial
Principles of Good Clinical Practice
Ethics and clinical trials - Ethics Committees
Portuguese legislation on clinical trials
Bibliography
Clinical Trials. Stuart Pocock. Wiley Medical Publications.
Principles and practice of Clinical Research. 2nd Ed. John Gallin. 2007.
Teaching method
Lectures and theoretical-practical classes.
Evaluation method
The evaluation will be mixed with 50% corresponding to the continuous assessment of participation in the sessions and the remaining 50% corresponding to the evaluation of a clinical trial protocol designed by the student.