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