Lehrinhalte
- Introduction to Clinical Research
- Clinical Research Ethics
- Clinical Study Protocol (Study Objectives, Study Hypothesis, Structure/Content, Templates, Amendments, IRB/IEC Submission and Approval)
- Basics of Clinical Trial Design (Population, Intervention, Control, Outcome (PICO))
- Implementing PICO into the Study Protocol (Inc./Exc. Crit, Intervention, Types of Control Groups, Outcome parameters (prim./sec., hard/soft, clinical/surrogate, Time-to-Event Data) )
- Clinical Trial Statistics (Measures of Central Tendency/Spread, Risk/Risk Factor, RR, OR, Hazard Ratio, Hypothesis Testing, Confidence Interval + Interpretation, Sample Size Calculation)
- Clinical Study Designs I (Observational/interventional, prospective/retrospective, Legal Classification: drugs/devices, Hierarchy of Clinical Evidence, Problems: Bias, Confounding)
- Clinical Study Designs II (Observational Studies: Cross-Sectional, Case-Control, Cohort Study )
- Clinical Study Designs III (RCTS, Randomization, Blinding, RCT-Modifications (cross-over, add-on, group sequential design) )
- Missing Data & Drop-Outs (Problems, Causes of Missing Data, Dealing with Missing Data (LOCF, BOCF) )
- Critical Appraisal of Clinical Research Papers (Quality Assessment, STROBE/CONSORT Statement)
- Meta-Analysis (Efficacy/Effectiveness, weighted summary, Forest-, Funnel-, L'Abbe-plot, Mantel-Hanszel Procedure, PRISMA Statement)
Prüfungsmodus
Endprüfung
Seminararbeit
Lehr- und Lernmethode
Vorlesung mit Übungen und Gruppendiskussionen
Sprache
Deutsch-Englisch