Munich Medical Research School

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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