Translational medicine can be broadly defined as ‘bench to bedside’ research where theories emerging from experiments in the laboratory in preclinical experiments are tested on individuals in early clinical trials.
Translational medicine also goes from bedside to bench: information obtained from preliminary human experiments is used to refine our understanding of the biological systems and principles underpinning different human diseases.
This enables further development and enhancement of therapeutics for treating and preventing the disease. In therapeutic terms, translational medicine will support the development and application of current and proprietary technologies for the selection of lead compounds most likely to succeed in the clinic. It will serve to accelerate drug discovery and lead to new therapies for patients. It is hypothesised that successful translational medicine will reduce “late” failure rates in phase 3 clinical studies.
Well designed phase 2 proof of concept translational medicine studies will support cost-effective determination of efficacy and safety through the use of biomarkers and experimental studies in humans. Translational Medicine encompasses:
- Basic science studies which define the biological effects of therapeutics in humans
- Investigations in humans which define the biology of disease and provide the scientific foundation for development of new or improved therapies for human disease
- Non-human or non-clinical studies conducted with the intent to advance therapies to the clinic or to develop principles for application of therapeutics to human disease
- Any clinical trial of a therapy that was initiated based on #1–3 with any endpoint including toxicity and/or efficacy. In addition, in the regulatory arena:
- Translational research may be defined as appropriate product development for clinical use in various stages of investigational clinical trial. For example, identity, purity and potency of a drug product must be studied during the early stages of the clinical trial. However, these tests must be in place before implementing phase 3 trials as required by the regulators.
What is the Translational Medicine Research Collaboration (TMRC)?
The aim of this initiative is to develop a world-leading network of clinical and scientific excellence throughout Scotland called the Translational Medicine Research Collaboration.
The TMRC is a unique collaboration involving Scotland and Wyeth, who will be responsible for all the costs of such studies sponsored by them. The Scottish parties in the TMRC will form a new company with Scottish Enterprise, through which the relationship with Wyeth will be managed.
The TMRC will see more than £50million injected into clinical research in Scotland over the next five years, placing Scotland as a world leader in translational medicine.
The conceptual development of the programme involves the establishment of a core Research Laboratory linking with the four major clinical academic centres at the Universities of Aberdeen, Dundee, Edinburgh and Glasgow and the NHS in Scotland, initially working with NHS Grampian, NHS Greater Glasgow, NHS Lothian and NHS Tayside.
The collaboration therefore covers over 70% of the Scottish population. Specialist patient-based studies will be performed at the four centres of excellence, linking seamlessly with the Research Laboratory which will be the focus of a number of key activities associated with this initiative, including:
- Establishing state of the art laboratory methodology and technology to be a leading international centre for translational medicine and development of biomarkers.
- The development and coordination of clinical trials carried out in the clinical research centres aimed at obtaining samples from clearly defined disease populations.
- Linking with the Scottish Clinical Research Network to manage streamlined ethical approvals, data collation and statistical analysis of results.
- The coordination of research activities to be carried out on the samples collected.