Evaluating Translational Research: A Process Marker Model

The concept of translational research has become critically important in contemporary biomedical research and practice. It is the subject of a rapidly growing literature, catching the attention of most leading biomedical journals and becoming the central focus of several new publications. Translational research is showing up in everything from research grant proposals to the curricula of leading medical schools and schools of public health. It is the focus of considerable effort in the biomedical industry (Birmingham, 2002) and is increasingly central to discussions of public health. The National Institutes of Health have made it a central priority, part of their “Roadmap” initiative. One of their primary programs, the Clinical and Translational Science Awards (CTSA), currently expends over $350 million per year to fund 55 research centers and by 2012 is expected to fund 60 centers at a cost of approximately a half billion dollars per year, making it the largest program at NIH. What is behind this considerable investment in translational research? One of the most significant motivations comes from a relatively small number of studies that show that it takes a long time to move basic scientific ideas to practice and health impacts. For instance, Westfall, Mold and Fagnon (2007) asserted that “It takes an estimated average of 17 years for only 14% of new scientific discoveries to enter day-to-day clinical practice” (p. 403). They based their claim on earlier work (Balas & Boren, 2000) that similarly stated “Studies suggest that it takes an average of 17 years for research evidence to reach clinical practice” (p.66) at a rate of 50% use in the relevant population. Other work (Contopoulos-Ioannidis, Alexiou, Gouvias, & Ioannidis, 2008) suggests that the median translation lag was 24 years between first description and earliest highly cited article. Because these studies typically only measure part of the process of moving from research to practice and eventually to health outcomes and impacts, these are likely to be significant underestimates. Translational research in many ways can trace its primary impetus to the notion that this time lag is seen as too long, certainly longer than necessary, and that there must be a better way to move research to practice more quickly without sacrificing quality or increasing costs. Proposed solutions include everything from better management of scientific research and increased process efficiency to wholesale rethinking of the biomedical research-practice endeavor for the 21st century. This paper focuses on the length of time that translational research takes. We do so because the long duration and time estimates to move research to practice were critical to making the policy case for significant investments in translational research. Nevertheless, temporality and duration concerns need to be considered in the context of many other factors including quality of research, cost, ethics, management, potential impacts, and so on (Rubio et al., 2010). The success of the translational research endeavor will ultimately be judged by whether it reduces the time and duration issue while at least preserving the current status of other factors like quality or cost. We argue here that one of the major tasks for evaluators involved in translational research is to help assess whether efforts like the CTSAs can reduce the time it takes to move research to practice and health impacts and increase the rate and volume of translation -- all while ensuring the quality and cost-efficiency of the conduct of research. This paper examines the concept of translational research from the perspective of evaluators charged with assessing translational efforts. In doing so we hope to: a) consider the most prominent models of translational research that have been offered in the literature, b) synthesize the major features that are shared across these models in order to show underlying commonalities, and c) suggest a new synthetic framework for evaluating progress in enhancing research translation that is consistent with existing models but avoids some of the major current problems. Specifically, we offer here an alternative to the dominant contemporary tendency to define translational research in terms of a series of discrete “phases.” We contend that this phased approach is insufficiently precise for most evaluation purposes and instead argue for the identification of key operational and measureable markers along a generalized process pathway from research to practice.