and patient safety. Despite significant rhetoric (particularly in the United States) about “learning health systems” (Institute of Medicine [IOM], 2007), the CTE and the health care delivery system have continued to diverge. This situation is undesirable both because research done within such a partitioned, parallel system may not be broadly generalizable and because the cost of maintaining parallel systems limits our ability to address critical gaps in knowledge.
The end result of the widening separation between research and health care delivery will be a serious deficit in new knowledge about the benefits and risks of specific drugs and devices in medical practice at a time when biological knowledge is expanding exponentially (see Figure 1) and warnings about the unsustainability of the system continue to escalate (IOM, 2008). This systemic divergence, in turn, deprives providers of reliable evidence upon which to base their practices, deprives patients of the expected return on research investments in science and medicine, and deprives policy makers of a rational basis for choosing one course of action over another.
The scope and pace of change in the overall health system will only increase as we enter the next decade, exacerbating the undesirable separation of research and practice. There is thus an urgent need to develop policies that will mitigate current stresses and increase CTE efficiency and effectiveness by expeditiously forming a deliberate plan to align the CTE and the emerging health care delivery system. Such an effort will require a new assertion of the societal values that underlie the CTE, a clarification of the objectives of such a plan, and accommodations on the parts of both the CTE and the health care delivery system to accomplish those objectives.
A decade ago, the National Institutes of Health (NIH) embarked upon a major effort to reshape the future of biomedical research. This framework for change, called the NIH Roadmap (Zerhouni, 2003), articulated a vision for clinical research in which each of more than 300 million Americans would have his or her own electronic health record (EHR). If individuals so chose (assuming appropriate privacy and confidentiality protections), the information in these EHRs could be used for research, and patients and their families would be joined together in networks that could answer critical questions about prevention and treatment. The fabric of constantly-accruing data would form the basis of a learning health system in which randomized trials could be performed by inserting randomization into the routine delivery of health care. This revolutionary approach would allow the rapid and definitive development of evidence at a relatively low cost.
Although this vision from a decade ago has not been achieved, much of it is within reach by 2020. Consolidations of service delivery and insurance organizations are changing the context of practice. Technological