Real World Study

Real World Study

EU: imi GetReal Glossary – Studies investigating health interventions whose design does not follow the design of a highly-controlled RCT and aims to reflect health intervention effectiveness in routine clinical practice. Real world studies do not typically include randomisation of trial subjects, but there are exceptions (e.g. pragmatic clinical trials). For the purposes of GetReal, real-world studies include, but are not limited to, the following: pragmatic clinical trials, non-interventional/ observational studies, drug utilization studies, post-authorisation efficacy/safety studies. RWS, by definition, generate RWD, which can subsequently be analysed and/or synthesized to produce RWE (Source: imi GetReal Glossary – 25 Oct 2016)