"The (discipline) turning observations in the laboratory, clinic, and community into interventions that improve the health of individuals and populations – from diagnostics and therapeutics, to medical procedures and observational behaviors"
- National Center for Advancing Translational Sciences, NIH
From bench to bedside
Translational science is introduced as a bridge between the scientific and the clinical fields; it gives evidence based research a backbone by connecting the dots of clinical research. In the past years we have seen the incremental costs of pharmaceutical development, with very few successful new developments. It requires the coming together of disciplines such as biology, chemistry, informatics, computer science, engineering, medicine, dentistry and public health. This way they can come together to create a real life impact in the healthcare community.
"The pressure of increasing R&D costs and low output in terms of critically novel drugs forced the Food and Drug Administration (FDA) to reconsider its own actions and those of major players in biomedical research in terms of timelines, costs, design, and, ultimately, success." (Principles of Translational Science in Medicine)."Translation will only work if clinical researchers and pre-clinical scientists have an educated vision on how to translate early findings (mostly in vitro findings) into useful, human medicines."
- Principles of Translational Science in Medicine.
Basic Science: An important scientific input is combined with a strong clinical motivation
Between each of these steps, there are key points that need to be achieved to move on to the next step.
What we already know as scientific based evidence research is that we begin with a thesis, and we test it pre-clinically in a lab until we reach a proposal to be tested in humans. Eventually we pass this on to humans and test it in what we know to be the Phases 1 to 3. After this we take the project in to market and we start Phase IV trials to analyze how the market reacts to our now product.
What this new science proposes is that everyone from the scientist to the physician educate themselves from the beginning on how to translate a scientific discovery and take it to a useful human application. Everyone in the process needs to have an idea of the unmet need they are working for and understand the role they play in the process of solving it. Therefore, we introduce Phases T1 to T4 – T for translation.
T1: Describes the translation of a scientific concept to a proposed human application that is proven to work pre-clinically.
T2: Combines preclinical studies in labs and animals to be tested in patients and used in clinical trials. This usually takes place in specialized health research institutions that are many times affiliated with universities.
T3: Takes these proven clinical trials in patients into clinical practices where we have a much larger number of people being affected by our product.
T4: The translation to the community at large, where we have gathered all sorts of data and done many clinical trials. We have gathered all sorts of permits, talked to insurance companies, state governments, other companies and so on. This is where we create a real-life impact.