Program Content
Modules of the PPCR course and its subtopics (based on the curriculum of 2017) are as follows:
Module 1: Basics of clinical research
- Selection and formulation of research questions
- Introduction to clinical trials
- Ethical and regulatory issues
- Basic study design
- Integrity in research
- The randomization process
- Study blinding
Module 2: Basic statistics
- Statistics: Data classification, Data distribution, Descriptive methods for categorical and continuous data
- Statistical Tests I: Estimation of parameters, Comparison of population means (Student t-test, ANOVA)
- Statistical Tests II: Correlation, Nonparametric tests for comparison of two or more groups, Analysis of Variance, Comparison of population (Chi-square test and Fisher's exact test)
- Statistical Tests III: Correlation, Chi-square test, Fisher's exact test
- Survival analysis
Module 3: Applied statistics
- Missing data and covariate adjustment
- Meta-analysis and subgroup analysis
- Introduction to regression modelling
Module 4: Practical aspects of clinical research
- Safety, clinical and surrogate outcomes
- Recruitment of study participants
- Participant adherence
- Clinical research in the context of Individualized Medicine (N-of-1 designs) and Business of clinical research
- Effective communication in clinical research
Module 5: Study designs
- Non-inferiority designs
- Phase III and multicentre trials
- Adaptive designs and interim analysis
- Observational studies
- Confounders in observational studies: Using the method of propensity scores
- Special panel: How to choose between RCT and observational designs