What is translational medicine

Fulfilling the unmet need of disseminating new knowledge in clinical and translational medicine can lead to a better clinical practice. Translational medicine, in enhancing the efficiency of biomedical discovery and application, rather than attempting to modify existing processes within disciplines, has come to serve as a unifying concept in the increasingly complex, specialised, and fragmented field of biomedical research.

It has emerged based on the synthesis of information gained from multiple investigative sources. Thanks to this approach, human biology and diseases are better understood and therapies more rapidly identified and tested, which together result in improved patient treatment and outcomes.

However, there is the need to stimulate the development of a clearer vision for translational and clinical research, to ensure that these disciplines remain powerful engines of creativity. Resources on medicines research and development, including patient involvement in the medicines lifecycle. Table of contents. Save as PDF Print this page. It is a cross-disciplinary field involving researchers, clinicians and patients in an effort to transition innovations from the research to the human clinical development phase and to enrich fundamental research with observations from clinical research.

Translational medicine lies at the interface between basic research, with the quest to understand the mechanisms of disease development, and clinical research which aims to assess the efficiency and safety of new treatments for patients.

This collaborative discipline is essential to translating scientific discoveries into new treatments that improve patient health. Translational medicine combines the skills of researchers, pharmacologists, and clinicians to evaluate new treatments and ultimately accelerate all the stages of drug development.

It is applicable to all diseases. Today, translational medicine more closely connects research and care, which ultimately accelerates decision-making for the launch of a drug on the market. This is called personalized medicine. That allows for a dynamic focus on forward and reverse translation as scientists follow the science. The Translational Medicine team explores new aspects of human biology as they become available for investigation. Understanding this real-time data helps to tailor clinical trials so that patients can receive novel medicines specific to their disease.

Learn More. Animal experiments, test tube analyses and early human trials do simply not reflect the patient situation well enough to reliably predict efficacy and safety of a novel compound or device. This goal, however, can only be achieved if the translational processes are scientifically backed up by robust methods some of which still need to be developed. This mainly relates to biomarker development and predictivity assessment, biostatistical methods, smart and accelerated early human study designs and decision algorithms among other features.

It is therefore claimed that a new science needs to be developed called 'translational science in medicine'. These days, "translational medicine" is a fashionable term describing the inclination of biomedical researchers to ultimately help patients. As if this wish would be novel, it is being increasingly used by scientific funding agencies e. NIH, European Union framework programs , regulatory authorities e.

FDA , researchers and patient care providers. Public and private responses in reflection of this observation have been numerous during the past years. This includes the "Critical Path" initiative by the FDA [ 2 ], the re-orientation of the NIH "road-map" , enforced by Dr Zerhouni's leadership towards translational medicine with an estimated 10 billion USD channeled into translational medicine centers and other activities; major drug companies and US universities e.

Duke or UPenn are being driven to establish translational medicine departments or at least working groups. So far, so good. Both in academia and industry, the wish to translate better has increased the awareness for interface problems; in academia, more clinical trials shall be performed as the tougher variant of medical research if compared with test tube research. Clinical trials require a lot more resources, paper work and endurance, and the rewards are still smaller in the public appreciation papers, impact factors.

This challenge has been identified and a huge amount of money is now supplied to investigator driven trials in academia, especially through the translational medicine centers by the NIH. The topic as such has been reflected in numerous reviews and opinion papers, e. It should be noted though that in Europe, investigator initiated trials IITs as the most important manifestation of clinical translational efforts in academia, are still rare and increasingly burdened by legislatory European drug laws, especially the 12 th revision of the German 'Arzneimittelgesetz' and financial constraints.

In industry, as both preclinical and clinical studies have been performed routinely and professionally long before this call for translational activities emerged, now the major task is the intertwining and alignment of preclinical and clinical studies along the artificially straight drug discovery and development process.

Here, it is more of an interface problem, than reflecting the lack of access to clinical trials. The main drawback of translational studies and related personalized medicine approaches in industry is the mandatory economical interest which is not in line with all sophistications of drug profiling leading to narrowed windows of opportunities.

It seems that in some instances, such translational efforts would have to come from parallel, independent, presumably academic IITs.