Although randomized clinical trials (RCTs) are the bedrock for establishing which interventions are efficacious, there is increasing recognition that they cannot address all needs, especially the need to determine, in a timely manner, the safety and effectiveness of different interventions used in the diverse array of patients and settings that make up a health care system. Interest has increased in the role of observational studies, and more specifically in registries and other electronic data sets, as a way to fill these critical gaps in evidence and as useful guides for helping to determine formulary placement. The recently released “highest priority challenge topics” from the National Institutes of Health (NIH) pointedly reference registries more than 20 times.1 Yet little guidance is available to help patients, physicians, payers, researchers, and policy makers evaluate the quality of information derived from these nonexperimental sources.
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