patient privacy. This and similar approaches require a standard clinical information model, such as Informatics for Integrating Biology and the Bedside (i2b2).6 Second, the FDA’s Mini-Sentinel distributed database initiative is exploring ways to develop evidence about the postmarketing safety of drugs, vaccines, and other products through data obtained from multiple sources.7 As of July 2011, Mini-Sentinel contains quality-checked data from 17 partner organizations, mostly large insurers and integrated delivery systems, covering nearly 100 million people (Platt et al., 2012). Its features include an operations center, secure portal, and opportunities by the partners to examine the queries that are distributed and review their own results before submitting them for pooling with results from other partners.

Third and perhaps most significant, CER is gaining strength. Currently, only 0.1 percent of health expenditures are devoted to this important research and development activity, but it is expanding. Steps involved in building a mature CER system might include the following:

•      Build the research base—weave CER into the fabric of care, so that clinicians do not have to choose to participate or perform extra steps in its conduct;

•      Build the business case—align financial incentives for providers with quality of care;

•      Address regulatory barriers—relax or harmonize requirements for informed consent, patient privacy, and other mandated protections, when appropriate;

•      Build demand for scientific evidence from patients, providers, payers, and purchasers—involve everyone in the transformation.

An example of effective collaboration in CER is the Hospital Corporation of America (HCA)-based, 42-hospital, 75,000-patient study of methicillin-resistant Staphylococcus Aureus (MRSA), the highly antibiotic-resistant pathogen affecting hospitals nationwide (Platt et al., 2010). The study, called REDUCE (Randomized Evaluation of Decolonization versus Universal Clearance to Eliminate)-MRSA, is comparing routine decolonization

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6 Informatics for Integrating Biology and the Bedside (i2b2), developed by the NIH-

7 Mini-Sentinel is a pilot program for the FDA’s more extensive Sentinel System, now



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