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17AMBMDT - Methodology and Design of Randomized Controlled Trials

Code Completion Credits Range Language
17AMBMDT Z 3 2+0
Lecturer:
Ivana Kubátová (guarantor), Kristýna Buzková, Aleš Tichopád
Tutor:
Ivana Kubátová (guarantor)
Supervisor:
Department of Biomedical Technology
Synopsis:

Basic notions of clinical testing, overview of basic types of clinical testing and their description. Informed consent. Legal aspects of clinical testing. The role of the State Institute for Drug Testing (SÚKL) and Institutional Review Boards. Helsinki declaration and good practice. The role of the clinical mentor. Data collection and processing. Safety and adverse events reporting.

Requirements:

Test of basic notions from the course.

Syllabus of lectures:

1. International Clinical Trials. Specific of Clinical Trials in different countries.

2. Introduction to clinical studies. General principles of clinical trials.

3. Phase studies, types of studies. Informed Consent.

4. Meta-analysis in clinical trials. Clinical outcomes. Practice: Clinical outcomes. Meta-analysis. Markovs models.

5. Principles of health economics.

6. Good Clinical Practice. Quality Assurance of Clinical Trials.

7. Biostatistics for clinical trials.

Syllabus of tutorials:

Home reading of recommended sources.

Study Objective:
Study materials:

ARTHUR M. NEZU & CHRISTINE MAGUTH NEZU: EVIDENCE-BASED OUTCOME RESEARCH, Oxford University Press, 2008, ISBN 978-0-19-530463-3

Note:
The course is a part of the following study plans:
Downloads: