Systematic Evaluation of Drug Safety in older adults [SEDS]: federated analysis of international register data using an emulated target trial framework

Older adults have the highest risk of adverse drug events, yet they are regularly excluded from clinical trials where drug safety is evaluated.

Apart from age restrictions in clinical trials, exclusion criteria often involve age-related factors such as co-morbidities and concomitant drug use. In this proposal, we aim to systematically evaluate drug safety in older adults using a wealth of European data.

With the ultimate goal of producing real-world evidence that can influence regulatory agencies and improve drug safety in clinical practice.In this five-year project we intend to create an improved workflow for evaluating drug safety in older adults using data sources mapped to the OMOP Common Data Model as part of the European Health Data Evidence Network (EHDEN).

The workflow will include a model for prioritization of medications for investigation. The model will target drugs used in regular practice, whereas new drugs will be evaluated as they reach the market.

Second, we will contribute to the methodological development for integrating co-morbidities, concomitant drug use and frailty in real-world evidence studies of drug safety from routinely collected data.

The analyses can be conducted in any of the Swedish register data sources we have direct access to, or within the ≈200 data partners in EHDEN.The findings will improve drug use in older adults, the part of the population with highest drug use and largest risk for adverse drug events.