What does RWE assess concerning a treatment's performance in practice versus ideal settings?

Answer

Effectiveness

Real-World Evidence (RWE) is specifically concerned with assessing effectiveness, which is defined as how a treatment or intervention actually performs when used by the general population in routine clinical workflows, contrasting with efficacy, which is measured under the highly controlled and ideal conditions characteristic of Randomized Controlled Trials (RCTs). While RCTs establish initial proof of concept and causation under strict controls, RWE steps in to evaluate the practical impact, accounting for comorbidities, varied adherence levels, and diverse patient demographics often excluded from initial trials. This evaluation of real-world performance provides a necessary complementary view to the initial certainty derived from tightly controlled studies.

Related Questions

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