Identify different phases of pre-clinical and clinical studies.
Know how to validate a diagnostic test.
To plan, analyze and make interpretation of the results of a clinical study.
To define a clinical sample size and study power.
To recognize interim analyses and safety monitoring board.
To define advantages and disadvantages of large registries and real-life data; Advantages and disadvantages of population-based studies.
To do and analyze cost-effectiveness studies and outcomes research.
Weekly - Available soon
Total - 42
Aguiar P (2007). Guia Prático Climepsi de Estatística em Investigação Epidemiológica. Lisboa: Climepsi Editores.
Fletcher, R., Fletcher, W., (2005). Clinical epidemiology: the essencials. Baltimore: Lippincott Williams & Wilkins.
Oliveira AG (2009). Bioestatistica, Epidemiologia e Investigação – Teoria e Aplicações. Lisboa: Lidel.
Pocock,S.J.(1983). Clinical Trials: a practical approach. Chichester: John Wiley & Sons.
Rothman K. Greenland S. Lash T.L. (2008) Modern Epidemiology 3rd ed. Philadelphia, PA. Lippincot Williams & Wilkins.
Theoretical sessions with slides presentation.
Discussion of published papers on clinical epidemiology.
Case study of clinical epidemiology made in Portugal.
Data analysis with SPSS and OpenEpi.
Participation in the sessions (20%), Individual test (50%) and group work with class presentation (30%)
Clinical epidemiology in the context of general epidemiology.
Pre-clinical studies. Clinical trial phases I, II, III, IV.
Superiority versus non-inferiority clinical trials.
Diagnostic tests: sensitivity, specificity, predictive values and ROC curves.
Stratified analyses and logistic regression; confounding and effect modification.
Kaplan-Meier survival analysis and Cox regression.
Determination of the sample size and power in a clinical study.
Advantages and disadvantages of large registries and real-life data; Advantages and disadvantages of population-based studies.
Analyze cost-effectiveness studies and outcomes research.
Case studies of clinical epidemiology.
Programs where the course is taught: