Related Experiment Video
Updated: Sep 13, 2025

Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index
Published on: January 8, 2020
[Aggregated statistics from Swedish health registries has been used for evaluating compliance with a
Karl-Mikael Kälkner1, Anders Sundström2, Rickard Ljung3
1docent, ämnesområdesutvecklare, Läkemedelsverket.
Abstract:
The daily regulatory work with pharmacovigilance includes requirements of risk minimisation measures (RMM). However, when it comes to evaluating the efficacy of RMM, methodological issues have been raised regarding commonly used surveys, and the updated Guideline on good pharmacovigilance practices, Module XVI Addendum II, proposes using mixed methods when RMM outcome is evaluated. The Swedish Medical Products Agency has used aggregated national register data to evaluate compliance to the contraindication for cyproterone in patients with previous or current meningioma. Among 13 036 patients diagnosed with meningioma during the period 2005-2022, 21 to 63 individuals had filled a prescription of cyproterone ever after diagnosis. This is regarded as a resource-efficient method to assess compliance to contraindications, although anonymous aggregated statistics entail an uncertainty of measurement because the data must not be granular enough to be attributed to single individuals.
Related Concept Videos
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Hazard Ratio
For example, in a clinical trial...
Relative Risk
Comparing the Survival Analysis of Two or More Groups
Bias in Epidemiological Studies

