Ever since October 2005, when Elias A. Zerhouni, M.D., then Director of the National Institutes of Health, published his seminal article “Translational and Clinical Science — Time for a New Vision” in the New England Journal of Medicine, medical professionals, researchers and policymakers alike have been grappling with the same question: What is translational science?
Subsequently, answers to that question have abounded in the literature and in the halls of every research hospital. As Steven H. Woolf, MD, MPH, points out in his recent JAMA Commentary, “The Meaning of Translational Research and Why It Matters,” some researchers define it as what occurs from bench-to-bedside in the development of new drugs, devices, and treatment options for patients, while others view it as “translating research into practice.” In other words, one definition is product driven, the other community and policy focused. As Dr. Woolf states, “translational research means different things to different people, but it seems important to almost everyone.”
Within Tufts CTSI, we’ve adopted a much discussed in the literature and more scalable approach to the definition. Translational science enhances a multidisciplinary collaboration and accelerates the application of that science across four steps:
T1 → T2 → T3 → T4
T1 or translation phase 1 jump-starts the translation of bench research to the patient bedside, albeit in a limited fashion. Here is where case study research and Phase 1 and 2 clinical trials usually occur. Will a new treatment X that was discovered in a hospital research lab work in, say, ten patients at that hospital?
T2 expands that sphere of discovery to the larger patient populations seen in Phase 3 and 4 clinical trials, observational studies, and perhaps some survey research. Again, using the same new treatment X example, will it now work in two hundred patients from different types of populations at different hospitals or clinic sites? How about thousands?
Once positive results are obtained from T2, then T3 can be launched into action. The practice-oriented stage of translational science, T3 relies on dissemination and implementation research to find out the answers to such questions as: Is treatment X now actually being used in the world-at-large, and if not, why not? The identification of new clinical questions, barriers, and gaps in care related to treatment X is focused on at this stage.
What happens if the results from T3 (or for that matter from any of the preceding stages) aren’t positive or aren’t as good as hoped for? The power of translational research is that it is an iterative process, allowing room for the returning to a prior translational stage to respond to treatment strategy barriers.
Finally, if T1 –T3 have reached their goals and responded effectively to any issues, new policy research is engendered in T4. What is the best method to reach clinicians and patients alike with a nationwide policy concerning treatment X so that they, first, will understand the new treatment and second, start to use it?
While there are those in the field who predominantly focus on T1 and/or T2 in their definition-making, Tufts CTSI envisions effective translational science as incorporating all aspects of the T1 – T4 scale. Each of these stages brings to life important research, but it takes all four to bring what happens in a lab’s Petri dish to the nightstands of the general population.
For more information about translational research, please visit the CTSI Portal at https://portal.tuftsctsi.org and click on ‘About Translational Research’.