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Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) National Institutes of Health  •  U.S. Department of Health and Human Services

Re-engineering the Clinical Research Enterprise

Translational Research

Overview

To improve human health, scientific discoveries must be translated into practical applications. Such discoveries typically begin at “the bench” with basic research — in which scientists study disease at a molecular or cellular level — then progress to the clinical level, or the patient's “bedside.”

Scientists are increasingly aware that this bench-to-bedside approach to translational research is really a two-way street. Basic scientists provide clinicians with new tools for use in patients and for assessment of their impact, and clinical researchers make novel observations about the nature and progression of disease that often stimulate basic investigations.

Translational research has proven to be a powerful process that drives the clinical research engine. However, a stronger research infrastructure could strengthen and accelerate this critical part of the clinical research enterprise. The NIH Roadmap attempts to catalyze translational research in various ways.

Enhancing the Discipline of Clinical and Translational Science

Growing barriers between clinical and basic research, along with the ever the increasing complexities involved in conducting clinical research, are making it more difficult to translate new knowledge to the clinic – and back again to the bench. These challenges are limiting professional interest in the field and hampering the clinical research enterprise at a time when it should be expanding.

Through discussions with deans of academic health centers, recommendations from the Institute of Medicine, and meetings with the research community, the NIH recognized that a broad re-engineering effort is needed to create greater opportunity to catalyze the development of a new discipline of clinical and translational science. The outcome, a bolder transforming vision for 21st Century, resulted in the launch of the Clinical and Translational Science Awards (CTSA) Consortium in October 2006.

The consortium began with 12 academic health centers located throughout the nation and expanded to 24 in September 2007. When fully implemented in 2012, about 60 institutions will be linked together to energize the discipline of clinical and translational science.

The purpose of the CTSA Program, which NCRR is leading on behalf of the NIH Roadmap for Medical Research, is to assist institutions to forge a uniquely transformative, novel, and integrative academic home for Clinical and Translational Science that has the consolidated resources to: 1) captivate, advance, and nurture a cadre of well-trained multi- and inter-disciplinary investigators and research teams; 2) create an incubator for innovative research tools and information technologies; and 3) synergize multi-disciplinary and inter-disciplinary clinical and translational research and researchers to catalyze the application of new knowledge and techniques to clinical practice at the front lines of patient care.

The members of the CTSA consortium are expected to serve as a magnet that concentrates basic, translational, and clinical investigators, community clinicians, clinical practices, networks, professional societies, and industry to facilitate the development of new professional interactions, programs, and research projects. It is anticipated that these new institutional arrangements, coupled with innovative advanced degree programs, will foster the nascent development of a new discipline of Clinical and Translational Science that will be much broader and deeper than the classical and separate domains of translational research and clinical investigation.

CTSAweb.org Exit Disclaimer: The CTSA Consortium has developed a Web site to ensure access to CTSA resources, enhance communication, and encourage information sharing.

For additional programmatic information about the CTSA program including the latest Request for Applications and Notices, please visit http://www.ncrr.nih.gov/clinicaldiscipline.asp.

Translational Research Core Services—The NIH-RAID Pilot Program

Promising ideas for novel therapeutic interventions may encounter roadblocks in bench-to-bedside testing. While translation is sometimes facilitated by public-private partnerships, high-risk ideas or therapies for uncommon disorders frequently do not attract private sector investment. Where private sector capacity is limited or not available, public resources can bridge the gap between discovery and clinical testing so that more efficient translation of promising discoveries may take place.

To help address this need, the NIH established a pilot program to make available, at no charge, certain critical resources needed for the development of new therapeutic agents. The NIH Rapid Access to Interventional Development (RAID) Pilot Program reduces some of the common barriers between laboratory discoveries and clinical trials for new therapies. Projects in both the early and late stages of pre-clinical development are suitable for NIH-RAID applications. The NIH-RAID Pilot will accept requests through 2011.

For the complete Funding Opportunity Announcement, please see http://grants.nih.gov/grants/guide/pa-files/PAR-07-358.html.

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This page last reviewed: March 19, 2008