Effectiveness Trials

Effectiveness Trials

EU: imi Get Real Glossary – Clinical studies investigating health interventions whose design does not follow the design of a randomised controlled clinical trial and aims to reflect health intervention effectiveness in routine clinical practice. Effectiveness studies do not typically include randomisation of trial subjects, but there are exceptions (e.g. pragmatic clinical trials). For the purposes of GetReal, effectiveness studies include, but are not limited to, the following: pragmatic clinical trials, non-interventional/ observational studies, drug utilisation studies, post-authorisation efficacy/safety studies. (See also: “real-world studies”, “drug utilisation study”, “pragmatic clinical trial” and “non-interventional/ observational study”)(Source: imi GetReal Glossary – 25 Oct 2016)