Clinical trial and the real world

Abstract

Observational studies of novel oral anticoagulants (NOACs) have been conducted in Europe and the United States; the results of these studies slightly differed from those of the phase III global study. This difference could probably be attributed to the inclusion and exclusion criteria of the phase III study, which are not reflective of the real-world scenario, as well as problems in NOAC dose setting in the real world. In the large-scale observational study, the efficacy and safety evaluation of NOACs against warfarin was different by the background factors (e.g., CHADS₂ score) of the target population. Dabigatran had superior safety in patients with a low CHADS₂ score. NOACs were consistently superior to warfarin in studies of medication non-adherence rates. A large-scale observational study needs to be conducted in Japan in the future to better reflect the real-world scenario.