Use Case 4 aims to prepare a good practice example for drug effectiveness and drug repurposing analyses of real-world data (RWD) for the drug post-authorisation stage.
The Sodium-glucose co-transporter 2 (SGLT2) inhibitors were initially approved to treat type 2 diabetes. However, several studies have provided information on their additional beneficial effect on cardiovascular outcomes in recent years. Accordingly, this drug class has high regulatory interest and so it will be used as an example in Use Case 4, aiming to:
- Describe national time trends in new oral antidiabetics introduced in the study period. By doing so, there’s an opportunity to illustrate whether and how suspected (and later confirmed) additional health benefits of a drug lead to changes in its utilisation and how these need to be accounted for in RWD analyses. Potential subgroups of patient trajectories will also be explored.
- Assess the effects of SGLT2 on cardiovascular health using an active comparator new-user design, with DPP 4 inhibitors as a reference – using overall and cause-specific hospitalisation and mortality as outcomes.
- Evaluate the comparative effectiveness of SGLT2 inhibitors by applying a target trial approach to RWD.
- Explore whether synthetically generated data used as a control arm results in similar conclusions to that of the original RWD. Artificial intelligence and machine learning algorithms will be applied.
Related Projects
Real4Reg’s work is in line with other European initiatives and projects that address regulatory and HTA needs within the context of Real-World Evidence (RWE).