Evidence-based medicine (EBM) hierarchically organizes different sources of medical information with meta-analyses, systematic reviews, and randomised clinical trials (RCTs) which provide the strongest and most reliable evidence and patient registries which fall under observational studies classified as a source of low-level evidence.
RCTs, the golden standard of medical evidence, are meant to generate unbiased data for inferring causality from observed associations whereas the observational studies are often seen as delivering poor quality information. However, the reality is not always so clear and straightforward. The main concern related to RCTs as guidance in medical decision-making is their applicability to daily clinical practice and generalisability to a patient population at large.
Real-world data (RWD) refer to any observational data collected outside of clinical trials or clinical investigations. Patient registries, belonging to the RWD family, are gaining in importance as a source of medical information. Therefore, it is critical to understand the specificity of such data and the way they should be interpreted.
This course focuses on the basic concepts of real-life medical research, the differences between the data from real-life settings including patient registries and experimental trials, and their relevance in clinical context. It will additionally provide tools for critical appraisal of the published registry data.