Research in Real-Life (RiRL) is an independent, research-driven organisation established to cultivate initiatives, provide evidence and drive quality standards within the growing field of real-life, pragmatic research. Through our research activities we contribute to the post-marketing assessment of therapeutic interventions and help drive the current paradigm shift in healthcare evaluation towards inclusion of real-life data.
Is the evidence 'pyramid' an archaic structure?
By employing strict controls, randomised controlled trials (RCTs) ensure high internal validity and their data currently form the bedrock of evidence used to inform regulatory decisions and clinical guidelines.
Yet despite their gravitas within traditional paradigms of pharmacovigilance, the numerous controls employed by RCTs impair the generalisability of their results; strict inclusion criteria result in a highly homogenous sample of 'ideal' patients while their limited time frame prevents examination of long-term factors physicians must consider in real-life practice. Observational and pragmatic trials provide valuable supplementary data on the comparative effectiveness and safety of interventions in the real world setting.