Conclusion
The findings demonstrate that having access to datasets in the OMOP-CDM format facilitates RWD analysis and can be useful for gleaning insights on comparative drug utilization, efficacy and safety, for risk-benefit assessments. While the initial conversion is challenging and needs to be done judiciously, the availability of a community of researchers and the sharing of previously written analytic code which serve as templates makes the process worthwhile. The ability to refine previously developed analytic codes with simple modifications is an important step in harnessing RWD to supplement benefit-risk assessments and creates a perpetual cycle of tool refinement needed to address the challenges of generating valuable insights from RWD and enable the conduct of robust evaluations on post-market drug efficacy and safety use cases, and ultimately make evidence-based decisions to optimise health outcomes.