Examples/wider context of the two main challenges encountered during the PASS programme
Challenge encountered | Example/wider context |
Finalising country-tailored study designs before the extent of rivaroxaban uptake was known | Uncertainty in the level of future rivaroxaban uptake in different European countries meant that finalising country-specific designs for each database study was challenging. This was particularly pertinent when evaluating the safety of rivaroxaban in the context of the ACS indication. Here, it transpired that rivaroxaban uptake remained low, and in hindsight, it would have been more pragmatic to have undertaken a drug utilisation study as a precursor to a rivaroxaban safety study. |
New research questions that arose during the programme | Because the database studies included in the PASS programme were truly observational, they provided an opportunity to learn not only about safety/effectiveness of rivaroxaban but also about physicians’ prescribing patterns regarding indications and dosing over a long period. As we had communicated to the EMA that access to the data sources was still possible (post addressing the original research questions), we received several comprehensible and relevant requests that were not included in the original protocol:
|
ACS, acute coronary syndrome; DOAC, direct oral anticoagulant; EMA, European Medicines Agency; LMWH, low-molecular-weight heparin; PASS, postauthorisation safety study; VKA, vitamin K antagonist; VTE, venous thromboembolism.