The Clinical and Translational Science Award (CTSA) Consortium and the Translational Research Model

Abstract

The shift from isolated researchers working in their individual laboratories to diverse research teams working in collaboration towards a common goal is a fundamental element of the Clinical and Translational Science Award (CTSA) (http://www.ctsaweb.org/). What is often misunderstood, however, is the depth and breadth of the translational paradigm. The NIH Roadmap discusses two basic steps of translation. First, basic science research must be translated to humans (the so-called T1 translation), and then secondarily translated into clinical practice (T2 translation) (http://nihroadmap.nih.gov/). Further work has demonstrated that in fact this second phase of translation includes two separate steps, first knowledge from T1 translational studies must be translated to patients (T2), and then we must translate our knowledge into actual clinical practice (T3 translation) (Westfall et al. 2007). Closer scrutiny, however, reveals more complexity and the need for many levels of translation. In this essay, I will briefly outline some of the myriad levels of translation necessary, and provide some examples to illustrate why further work is needed at these levels. Further, I will briefly describe the CTSA Consortium and discuss how this new model of research is attempting to address some of these needs. Translation takes many forms. If we start with a finding in a basic science laboratory that might have applications to the care of humans, such knowledge must go through many steps before it can have clinical applications. Basic scientific data must be translated into animal models, often this translation may start with non-primate mammals with subsequent translation into non-human primates. These pre-human experiments represent many layers of translation and require the collaboration of many scientists working in different research laboratories. Next, under the T1 translation, clinical researchers must assess the clinical applications in limited clinical conditions through controlled early-phase clinical trials. Next, knowledge from these early clinical experiments must be applied more broadly through phase 3 trials. Once clinical applications have been demonstrated through this T2 translation, clinicians must find ways to move these findings into the daily care of patient (T3). Merely translating findings to the actual bedside, however, is not enough. Moving scientific knowledge into the public sector and thereby changing people’s everyday lives represents a major challenge (T4). While many focus heavily on T1 and T2 translation, without T3 translation we cannot bring the benefits of medical research to individual patients. There exist many examples where despite excellent clinical research demonstrating clear benefit, individual physicians are slow to adopt best practices. One such example is the evidence that despite the clear benefits of statins in patients with elevated cholesterol, many patients for whom statins are indicated are not placed on appropriate therapy (Pasternak et al. 2002). Further, we must also translate scientific knowledge into people’s everyday lives. Merely knowing that an intervention can