Clinical Trials
Synopsis
The randomized controlled clinical trials are the most widely used experimental studies in the evaluation of treatment effect on patients. It is therefore important that investigators understand the importance of the planning stage of a clinical trial as well as of a proper data analysis and correct interpretation of the results. This course is intended to explain some basic principles of clinical trials, detailing the concepts behind randomization and methods for designing and analyzing trials.
Target audience
Users and researchers from the medical sciences areas.
Level - basic
Level - basic
Topics
- Phases of a clinical trial
- Types of bias and variability of the primary clinical endpoint
- Internal and external validity
- Types of control groups
- Randomization methods and blinding
- Types of designs
- Superiority, non-inferiority and equivalence trials
- Types of variables
- Protocol deviations
- Data analysis sets: full analysis set and per protocol set
- Effect measures
- Safety and tolerability evaluation
- Sample size
Schedule
This is a three-days course with the following structure:
- 17:00 - 20:00 Lecture
Lecturer
Ana Luísa Papoila, Professor at the Faculty of Medical Sciences of the New University of Lisbon and full member of the Center of Statistics and Applications of University of Lisbon
Registration
|
|