Lewin Contact: Cliff Goodman

Comparative effectiveness research (CER) is reshaping the evaluation of health care technology in the United States, with implications for innovation, regulation, payment, access, quality, and costs. The interest in CER arises from a widely perceived shortfall in evidence to inform decisions by clinicians, patients, health care provider organizations, and payers. The evidence expectations inherent in CER offer distinct challenges to the laboratory sector, as well as opportunities for those that can demonstrate the value of laboratory tests in the CER paradigm. 

This report explains the rationale for CER, what CER is, and its significance for laboratory medicine. It describes the types of evidence generated by CER and how it compares with the evidence usually generated for regulatory purposes. The report summarizes current federal activities in CER that are relevant to laboratory medicine. Further, it describes implications of CER for the laboratory testing sector.

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