What aspect of evidence do RWE studies primarily address that RCTs often limit due to strict criteria?
Answer
External validity of evidence
Traditional Randomized Controlled Trials (RCTs) are intentionally designed with strict inclusion and exclusion criteria to minimize bias and establish causation under ideal, controlled conditions. However, this tight control often limits how well those results translate to the general public, thus restricting the external validity of the findings. Real-World Evidence (RWE) steps in precisely to address this gap by assessing how treatments perform across the full spectrum of demographics, concurrent medical conditions, and socioeconomic statuses found in everyday clinical practice, thereby demonstrating the external validity of the treatment's impact.
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