Real-world data and evidence: FAQs
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Physicians and providers are interested in the use of real-world evidence for the assessment of patients’ treatment adherences, monitoring the safety of newly approved interventions and assessing adverse events associated with these. This real-world evidence can also inform stakeholders as to whether certain interventions are more effective in specific patient subgroups.
Payers employ real-world evidence, in the form of claims and billing data, to evaluate the cost–effectiveness of interventions, to help make drug coverage decisions and improve the affordability of healthcare.
Real-world evidence is also employed in regulatory decision-making, the post-marketing surveillance of drugs and medical devices, and in the development of guidelines and decision support tools for clinical practice.
By contrast, real-world data depict patients’ experiences in their real-world environments, outside of tightly controlled, unnatural clinical trial settings. Real-world evidence studies provide insights concerning whether a treatment does work, for real people in real-world environments, accounting for their other indications and medications, and the results pertain to a much larger, heterogenous patient population.