Translational research is defined by the National Institutes of Health (NIH) as “the process of applying ideas and discoveries generated through basic scientific inquiry to the treatment or prevention of human disease.”
It’s called “translational” research because the goal is to translate scientific insights into actual, practical therapeutic interventions that save peoples’ lives and improve their health. "Translational science" refers to the study of those methods which are best at moving biomedical research forward.
The course of each medical advance is different but most proceed through the following stages: from discovery to testing to implementation to adoption.
The process begins when a new biological phenomenon is discovered or a technological innovation is developed, usually in a lab through the time-tested procedure of trial and error. Before that idea can be translated into a new medical treatment, however, it must be tested first to determine whether it is safe and effective.
Depending on the nature of the proposed treatment, whether it’s a drug, behavioral intervention or new medical device, it will be tried out on animals or tissue samples before being tested on small groups of human subjects, after receiving approval from the U.S. Food and Drug Administration (FDA). The new treatment might also be tried out in a computer simulation.
If the treatment appears promising it can proceed to clinical trials (see the sidebar at right). These occur in phases involving successively larger groups of volunteer test subjects and control groups. Treatments that are successful in carefully controlled clinical trials then enter the wider health care environment as they are implemented in the community.
Institutional and government oversight every step of the way is designed to protect volunteers from any harm that could result from participation in a clinical trial. Oversight is conducted under strict ethical and legal guidelines by unbiased third parties such as a university’s Institutional Review Board (IRB) and experts at the FDA.
If the intervention works and it receives regulatory approval, health care professionals can then begin to administer it in real-world clinical settings to treat actual patients. But that doesn’t mean the study phase is over yet. Follow-up testing is conducted once the treatment has been introduced into the more natural, less controlled environment of the clinic, hospital or home.
In addition to checking for efficacy, investigators at this point are looking for side-effects that might not have shown up in the smaller, more controlled setting of the clinical trial.
Successful innovations can then be disseminated to the broader medical community, possibly even becoming the new standard of treatment for that disease or disorder.
Scientists describe this multi-phase process as the “translational spectrum” or “translational pipeline.” Each metaphor highlights a different aspect of the process but, either way, the goal is to move scientific discoveries “from bench to bedside” — which is to say, from the laboratory or academic setting into the actual health care field — as quickly and safely as possible.
The translational spectrum is customarily divided into four phases:
T1: Translation to humans
T2: Translation to patients
T3: Translation to practice
T4: Translation to population health
The spectrum metaphor highlights the fact that these distinctions are not always hard and fast. Boundaries may overlap, and research doesn’t always progress in a straight line from T1 to T4.
For instance, say a researcher has discovered that an anesthetic routinely administered by orthopedic physicians via nasal spray to desensitize broken noses is just as effective as the traditional novocaine injection for numbing the top row of a dental patient’s teeth (while relieving patients of the anxiety often associated with injections). An investigator in UB’s School of Dental Medicine is putting just such a treatment through clinical trials. Since the nasal spray was already approved for use in humans, that course of research was able to begin at a more advanced stage of the translational spectrum than other novel interventions.
Movement along the scale between T1 and T4 is not one-way. Results from a T4 population outcome study might inform a future T1 pilot study, for instance, or a T3 trial might reveal the need for more studies at the T2 level. Results at any point on the spectrum might indicate new pathways for research at the “T0” (basic science) stage.
The goal of translational science is to keep the flow of ideas moving from labs and universities into the development of improved health care diagnostics, drugs, therapies and devices.
The translational “pipeline” emphasizes the directedness of translational research, but it also highlights the fact that obstacles and bottlenecks that slow down progress can, and do, occur. Translational researchers work to identify those barriers and help break them down in order to deliver the best health care possible in the timeliest manner.