Translational medicine

Translational Medicine is the emerging view of medical practice and interventional epidemiology, as a natural 21st century progression from Evidence-Based Medicine. It integrates research inputs from the basic sciences, social sciences and political sciences to optimise both patient care and also preventive measures which may extend beyond the provision of healthcare services.

Translational Research describes the underlying basis for Translational Medicine, described by Lean et al (2008), as 'the process which leads from evidence based medicine to sustainable solutions for public health problems'. Fulfilling the promise of translational research for improving the health and longevity of the world's populations depends on developing broad-based teams of scientists and scholars who are able to focus their efforts to link basic scientific discoveries with the arena of clinical investigation, and translating the results of clinical trials into changes in clinical practice, informed by evidence from the social and political sciences.* It has three phases (Lean et al 2008):

Phase 1 Translational Research is the research process that explores needs, develops potential treatments in basic laboratory research, and tests safety and efficacy, principally in randomised clinical trials. The concept arose from research into pharmacotherapy and formed the initial basis for evidence-based practice and clinical guidelines, now incorporated into Translational Medicine. In the case of drug discovery and development, 'translational research' typically refers to the translation of laboratory-based research into real therapies for real patients. This is often called the "bench to bedside" definition. Many pharmaceutical companies are building (phase 1) translational medicine groups to facilitate the interaction between basic research and clinical medicine, particularly in clinical trials. The clinical evaluation of therapies drawn from other disciplines (eg psychology, physical activity, nutritional) can also be included within Phase 1 Translational Research.

Phase 2 Translational Research examines how findings from clinical science, shown to be efficacious and safe treatments established in phase 1 translational research, function when they are applied in routine practice (Hiss, 2004). It thus addresses development and application of new technologies in a patient driven environment - where the emphasis is on real patients in real-life situations, where demographic factors and competing priorities modify clinical decisions, and treatment responses. Phase 2 Translational Research thus informs guidelines about needs, acceptability, effectiveness, and cost efficiency in ecological settings and policies to promote uptake for optimal management and resource use. As examples, consumer research explores patients’ behavioural responses to interventions and provides important insights into compliance; health economics adds the evaluation of cost effectiveness and cost avoidance. These needs challenge hierarchical views of "research quality" and funding allocation, traditionally dominated by randomised controlled trials, and point to the need for non-hierarchical typological approaches (Berwick 2005, Petticrew 2003).

Phase 3 Translational Research adds the necessary information to convert treatments and prevention strategies, shown to be effective and cost-effective in Phase 2 Translational Research, into sustainable solutions (Lean et al 2008). Thus governments can generate enduring evidence-based policies. These require different types of research processes to evaluate the complex interacting environmental and policy measures that affect susceptibility to disease and the sustainability of clinical and public health management and prevention strategies. Achieving sustainability depends on evidence from two fronts. Firstly, closed-loop audit approaches are needed within Continuous Improvement Methodology to refine the intervention. Lessons can be learned from successful commercial and product developments, which use multidisciplinary non-experimental research to inform incremental improvements (Berwick, 2005). Continuous improvement methodology is known as "kaizen" in Japanese, where it originated. Secondly, research is needed to obtain evidence for making changes to multiple environmental and policy factors which will reduce the need for funding to sustain the intervention.

An example - Obesity. Controlling the mounting epidemic of obesity and its secondary diseases will require new multicomponent methods for effective treatments, based on randomised clinical trials and continuous improvements of community-based approaches, and also effective and sustainable approaches for prevention. This needs an integrated view of educational and environmental actions to facilitate greater physical activity, together with fiscal and regulatory changes to promote production, promotion, and delivery of healthier meals and total food supply. Practitioners, policy makers, and the public need sound evidence from different and new research methods, involving both experimental and non-experimental methodologies, that are sensitive to cultural and ethnic priorities.

Implications of Translational Research: Reliance on actions within health services will be insufficient to control rising obesity, diabetes, and associated diseases. Clinical science and ecological support from effective policies cannot continue to be regarded as independent disciplines. Integrated training in Translational Research methods is needed for clinicians, guideline writers, grant awarding bodies, and policy makers, in order to redress current biases in funding and research publications, in order to reflect better the balance of research efforts which are necessary for better assessment of complex evidence-bases, to integrate effective and culturally sensitive interventions with supporting environmental changes, and to encourage continuous improvement of evidence based public policies (Lean et al 2008).

References

* [http://mednews.stanford.edu/stanmed/2002fall/letter.html Letter] Philip Pizzo, MD - Dean, Stanford School of Medicine
* Geraghty J. Adenomatous polyposis coli and translational medicine. Lancet. 1996 Aug 17;348(9025):422.
* Marincola FM, Translational Medicine: A two-way road. J Transl Med. 2003 Jul 24;1(1):1.
* Stacey P Mankoff, Christian Brander, Soldano Ferrone, and Francesco M Marincola. Lost in Translation: Obstacles to Translational Medicine, J Transl Med. 2004; 2: 14.
* Woolf, SH. The Meaning of Translational Research and Why It Matters. JAMA 2008;299;211-213.
* Feldman, A. Does Academic Culture Support Translational Research? CTS: Clinical and Translational Science 2008;volume 1, issue 2;87-88
* Lean MEJ, Mann JI, Hoek JA, Elliot RM and Schofield G. Translational Research: from evidence-based medicine to sustainable solutions for public health problems. British Medical Journal 2008;337: a863.
* Hiss RG. Fundamental issues in translational research. Translational research—two phases of a continuum. In: From clinical trials to community: the science of translating diabetes and obesity research. Natcher Conference Center, National Institutes of Health, Bethesda, Maryland, USA, 2004:11-4. www.niddk.nih.gov/fund/other/Diabetes-Translation/conf-publication.pdf.
* Berwick DM. Broadening the view of evidence-based medicine. Int J Qual Saf Health Care 2005;14:315-6.
* Petticrew M, Roberts H. Evidence, hierarchies, and typologies: horses for courses. J Epidemiol Commun Health 2003;57:527-9.