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Surrogate outcomes often are used in randomized controlled trials (RCTs), because they occur sooner and are easier to measure than patient-relevant outcomes. For example, in a trial of a new statin drug, surrogate outcomes (e.g., lipid levels) could be evaluated much more quickly than patient-relevant outcomes (e.g., death). In this study, investigators examined whether treatment effect sizes are larger in RCTs using surrogate outcomes than in RCTs using patient-relevant outcomes.
RCTs published during 2005 and 2006 in six important general medicine journals were reviewed. A patient-relevant outcome captured “how a patient feels, functions, or survives.” A surrogate outcome was “a biomarker (for example, low density lipoprotein cholesterol l…