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 real-life research activities we contribute to the post marketing assessment of therapeutic interventions and help facilitate the current paradigm shift in healthcare evaluation towards the inclusion of real life data.
Is the ‘evidence pyramid’ an outdated structure?
By employing strict controls, randomised controlled trials (RCTs) ensure high internal validity and their data currently forms the bedrock of evidence used to inform regulatory decisions and develop clinical guidelines - indicating their gravitas within traditional paradigms of pharmacovigilance.
Yet the same controls which strengthen internal validity impair the generalisability of RCT results; strict inclusion criteria result in a highly homogenous sample of participants for whom the treatment is likely to be safe, meaning that only a subgroup of the diverse population treated in every day clinical practice are represented. Furthermore, the relatively short time frame of RCTs restricts examination of the many long-term factors clinicians must consider in real life practice, such as adherence, tolerability and individual patient and prescriber preferences.