Many informatics products now are legacy-driven. An AHSS that has invested in separate systems for billing and research does not have incentives to replace both systems with a new, integrated product. Different academic institutions have their own systems, and little interoperability exists. While federal regulators, health care providers, and the IT industry focus primarily on the “meaningful use”4 of EHRs, according to a workshop participant they are not sufficiently investing in connectivity and the use of EHRs in the health care setting for clinical trials. Consequently, the records of patients who receive care from different providers, health systems, or academic institutions are all incomplete. It was suggested by one workshop participant to start increasing efficiency and interoperability by merging information for compliance systems such as financial disclosure forms. Billing, scheduling, and other processes also could be combined.

International Competition

Many participants noted that the United States will have to invest more heavily to remain competitive in the field of clinical research and to achieve more effective and value-driven health care. While other countries are increasing their commitment to medical research, in recent decades U.S. health policy concerns have been concentrated on cost containment. Clinical research has not been central to the discussion, even though research could lead to a significant reduction in expenditures for medically unnecessary procedures, which contribute to an estimated $750 billion to $765 billion of excess in annual U.S. health expenditures (IOM, 2010b).

Workshop participants expressed differing views about the best way to meet the challenge of globalization in clinical trials. One view was that it may make sense to let other countries undertake industry-driven studies, of the type regulated by FDA, while the United States moves into quality improvement and clinical effectiveness research as an area of growth. A contrasting view was that, to the extent clinical trials are moving offshore due to excessive U.S. research costs, this is a loss to the United States. In this view, research should be conducted in the United States if the results are to be applied to U.S. populations specifically. Another


4 The HITECH Act, part of the American Recovery and Reinvestment Act of 2009, allowed CMS to provide financial incentives to health providers for the adoption and “meaningful use” of certified EHR technology. Meaningful use entails three components: (1) the use of certified EHR technology in a meaningful manner, such as e-prescribing; (2) the use of certified EHR technology for electronic exchange of health information to improve quality of health care; and (3) the use of certified EHR technology to submit clinical quality and other measures. For more information, visit (accessed March 28, 2012).

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