Personalized medicine and comparative effectiveness research in an era of fixed budgets.

For personalized medicine to be widely adopted in clinical practice, stakeholders need evidence of effectiveness, cost effectiveness and financial viability. Comparative effectiveness research (CER) using population based, retrospective data can inform assessments of personalized medicine. The purpose of this paper is to explore the potential and the limitations of CER. While the analytic methods and data used for CER overcome many of the disadvantages of randomized controlled trials, there are significant barriers, including lack of routinely collected genetic information, patient-reported outcomes and information on new and emerging technologies. Recommendations for using CER include augmenting current data with genetic information, promoting the collection of uniform health outcomes, using value of information analysis to guide development of new technologies, and greater use of decision analysis. Finally, in order to address stakeholder concerns regarding short term financial viability, additional emphasis should be devoted to cost analysis of implementation costs and overall financial impact.