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Comparative effectiveness research (CER) has emerged as a major component of health care and policy research over the past two decades. Several definitions of CER have been proposed. The most widely used is the definition provided by the Institute of Medicine (IOM; now the National Academy

of Medicine) committee convened to define national priorities for CER in 2009. According to this definition, “Comparative effectiveness research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care”. According to the IOM report, CER is conducted in order to develop evidence that will aid patients, clinicians, purchasers, and health policy makers in making informed decisions. The overarching goal is to improve health care at both the individual and population levels.

Insofar as the focus of CER is on effectiveness, the contrast with efficacy needs to be made. Efficacy refers to the performance of a medical intervention under “ideal” circumstances, whereas effectiveness refers to the performance of the intervention in “real-world” clinical settings. With efficacy and effectiveness defining the two ends of a continuum, actual studies typically occupy one of the intermediate points. However, effectiveness trials are expected to formulate their aims and design based on the realities of routine clinical practice and to assess outcomes that are directly relevant to clinical decisions. Such trials are often termed “pragmatic clinical trials” in the CER lexicon.

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