How should one read "real-life data" regarding NOAC's? "The case with rivaroxaban"

Abstract

Randomised controlled trials (RCT) are considered as gold standart for clinical studies because of their standart protocols, well-defined case and control groups, and their statistical methods for pre-defined outcomes. Real-world studies (RWS) are generally performed to evaluate and/or obtain long term efficacy and safety data of a particular drug-intervention or application in populations who were not included in RCT for various resons or in real world settings such as routine health care systems. As RWS give the opportunity for comparisons which do not exist in the original protocols of RCT; currently they have been the choice of research method in the clinical drug investigations. Increasing use of non-vitamin K antagonist oral anticoagulants (NOAC) in routine clinical practice and their efficacy and safety data coming from RCT have been supported by the data and evidences obtained from the real world studies. In this article; following a brief evaluation of advantage and limitations of RWS, some real world data and evidences about rivaroxaban using various study designs such as noninterventional observations, registries and database analysis will be reviewed and summarized.