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      Translational medicine: science or wishful thinking?

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      1 ,
      Journal of Translational Medicine
      BioMed Central

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          Abstract

          "Translational medicine" as a fashionable term is being increasingly used to describe the wish of biomedical researchers to ultimately help patients. Despite increased efforts and investments into R&D, the output of novel medicines has been declining dramatically over the past years. Improvement of translation is thought to become a remedy as one of the reasons for this widening gap between input and output is the difficult transition between preclinical ("basic") and clinical stages in the R&D process. 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'.

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          What's next in translational medicine?

          Translational medicine is the integrated application of innovative pharmacology tools, biomarkers, clinical methods, clinical technologies and study designs to improve disease understanding, confidence in human drug targets and increase confidence in drug candidates, understand the therapeutic index in humans, enhance cost-effective decision making in exploratory development and increase phase II success. Translational research is one of the most important activities of translational medicine as it supports predictions about probable drug activities across species and is especially important when compounds with unprecedented drug targets are brought to humans for the first time. Translational research has the potential to deliver many practical benefits for patients and justify the extensive investments placed by the private and public sector in biomedical research. Translational research encompasses a complexity of scientific, financial, ethical, regulatory, legislative and practical hurdles that need to be addressed at several levels to make the process efficient. Several have resisted the idea of supporting translational research because of its high costs and the fear that it may re-direct funds from other biomedical disciplines. Resistance also comes from those more familiar with traditional clinical research methods. In this review, we argue that translational research should be seen as enabled by ongoing efforts in basic and clinical research and not competing with them. Translational research provides the knowledge necessary to draw important conclusions from clinical testing regarding disease and the viability of novel drug mechanisms. Advancing translational research requires education and new sources of funding. This could be achieved through public and congressional education by a joint coalition of patients' advocacy groups, academia, drug regulatory agencies and industry.
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            In support of descriptive studies; relevance to translational research

            The contemporary scientific establishment equates hypothesis testing to good science. This stance bypasses the preliminary need to identify a worthwhile hypothesis through rigorous observation of natural processes. If alleviation of human suffering is claimed as the goal of a scientific undertaking, it would be unfair to test a hypothesis whose relevance to human disease has not been satisfactorily proven. Here, we argue that descriptive investigations based on direct human observation should be highly valued and regarded essential for the selection of worthwhile hypotheses while the pursuit of costly scientific investigations without such evidence is a desecration of the cause upon which biomedical research is grounded. There are good things so in the tide pools and interesting thoughts to be generated from the seeing. Every new eye applied to the peephole which looks out at the world may fish in some new beauty and some new pattern, and the world of the human mind must be enriched by such fishing. John Steinbeck – Foreword to the Third Edition of Ed Ricketts' "Tides".
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              Translational medicine: can it really facilitate the transition of research "from bench to bedside"?

              Translational medicine is intended to facilitate the transition of basic science results to clinical practice, thereby sharing major aspects of clinical pharmacology. Biomarkers need to be developed to achieve this, and their predictive values need to be assessed. Despite all the attempts to increase output from costly pharmaceutical research investments, all stakeholders complain of the decreasing efficiency of drug development processes, and expensive late attritions seem to be seen at increasing rates. How can translational medicine improve this apparent mismatch between effort and tangible result for daily medical practice? What is missing, and where do we stand?
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                Author and article information

                Journal
                J Transl Med
                Journal of Translational Medicine
                BioMed Central
                1479-5876
                2008
                17 June 2008
                : 6
                : 31
                Affiliations
                [1 ]Clinical Pharmacology Mannheim, University of Heidelberg, Mannheim, Germany
                Article
                1479-5876-6-31
                10.1186/1479-5876-6-31
                2442586
                18559092
                a4060e64-3aaf-43a6-9269-10ff569577a7
                Copyright © 2008 Wehling; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 2 June 2008
                : 17 June 2008
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                Medicine

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