Non-randomized Trial with Historical Controls
A study in which investigators compare outcomes among a group of patients who are receiving a new treatment with outcomes among patients who received standard treatment in a previous period. In these studies, patients receiving new treatment compose the experimental group and patients who received standard treatment are historical controls.
Bias may be a concern in this approach when subjects receiving new treatment are not comparable to subjects who received traditional treatment.
Berger, M. et al. 2003. Health Care, Cost, Quality, and Outcomes: ISPOR Book of Terms, Lawrenceville, NJ: International Society for Pharmacoeconomics and Outcomes Research.
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