What's next in translational medicine?

Abstract

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.

A Radical Proposal: Integrate Clinical Investigation into the U.S. Health Care System

“…Others have suggested national bodies for biomedical research policy and the promotion of clinical and translational investigation and, in particular, new funding strategies (13)(14)(15)(16)(17). However, these eff orts principally address investigator-funding issues and do not address the need to integrate clinical research with the health care system.…”

The trouble with translational medicine

“…The issue of our collective failure to translate basic research into clinical benefit has been amply discussed [9][10][11][12][13]. Indeed, participants in translational medicine meetings often complain about ethical, regulatory, financial and educational barriers to success.…”

Strategies for Translational Research in the United Kingdom

“…This board has overseen an increase in the number of renal patient-based translational studies from single figures to more than 55 in less than 3 years. Groups that consist of a mixture of researchers and patient advocates are well placed to help drive and focus research and to present a coherent case for the research in the public sphere (19).…”