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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, including the following two projects:

Regional Translational Research Centers

Key to building a strong infrastructure is increasing interactions between basic and clinical scientists and easing the movement of powerful new tools from the laboratory to the clinic. One strategy to achieve this involves NIH facilitating the development of Regional Translational Research Centers, or RTRCs. These centers will provide sophisticated advice and resources to help scientists master the many steps involved in bringing a new product from the bench to medical practice. Such steps involve laboratory studies to understand how a therapy works and animal studies to determine how well a therapeutic agent is absorbed into the body, how it is distributed to target tissues, how effective it is, and how likely it may be to cause unanticipated side effects.

For additional information on the RTRC initiative contact Anthony Hayward, M.D., Ph.D., National Center for Research Resources, (301) 435-0791, haywarda@mail.nih.gov.

Translational Research Core Services

Once a potential new drug is developed, sufficient amounts must be made according to rigorous standards for testing—first in animals, then in people. The NIH Roadmap also envisions enhancing clinical researchers' access to sophisticated manufacturing capacity and expert advice to ensure that drug-development regulations are observed. This program, entitled Translational Research Core Services, will be modeled on or may evolve through expansion of the National Cancer Institute's Rapid Access to Innovation Development program, which currently provides such resources to the cancer research community. Their availability to the broader research community should expedite discoveries for other major public health challenges.

For more information on the Translational Research Core Services program, contact Josephine Briggs, M.D., National Institute of Diabetes and Digestive and Kidney Diseases, (301) 496-6325, briggsj@extra.niddk.nih.gov.

The URL for the NIH Roadmap web site is nihroadmap.nih.gov. Further information about NIH can be found at its Web site: www.nih.gov.

 

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