Summary

How do you compare medicines in the best and most comprehensive way?

In addition to traditional clinical trials, Real World Evidence (RWE) has become a central basis for such comparators.

Scientific evidence based on data collected from sources other than traditional clinical trials, e.g. electronic health records, has become decisive when the effectiveness and safety of medicinal products is assessed, e.g. in connection with applications to the Medicines Council.

Methodologically, making comparisons between drugs, however, can be a challenging task. First, it is crucial to choose the appropriate method for the research question and the characteristics of the data being analysed. Second, it is important to consider the limitations and assumptions of each method to ensure that the analysis is conducted and interpreted correctly. Thus, insight into the RWE methodology used is essential.

This course gives you an overview of different statistical approaches for making effectiveness comparisons between drugs. This includes both how to make direct and indirect comparisons of effectiveness of treatment options in real-world settings, and how to create synthetic control arms.

Keywords

• Market access
• Real World Evidence (RWE)
• Statistical analysis
• Evidence generation
• HTA evaluations