Thursday, February 24, 2005

NIH ROADMAP-Re-engineering the Clinical Research Enterprise

An enriched pipeline of biomedical discoveries, an infrastructure to facilitate the translation of these discoveries from the laboratory to the clinic, and a robust force of clinical investigators will make it possible to test new therapeutic and preventive strategies in larger numbers of patients far sooner than currently possible. These large studies are often best conducted through networks of investigators who are equipped with tools to facilitate collaboration and information sharing.
Because of the vast number of therapies, diagnostics, and treatments that must be evaluated through clinical trials, many clinical research networks operate simultaneously, but independently, of each other. As a result, researchers must sometimes duplicate data that already exists because they are unaware of the data or do not have access to the data. Standardizing data reporting would enable seamless data- and sample-sharing across studies. By enhancing the efficiency of clinical research networks through informatics and other technologies, researchers will be better able to broaden the scope of their research. Reduced duplication of studies will leave more time and funds to address additional research questions.
The Clinical Research Networks facet of the Re-engineering the Clinical Research Enterprise Roadmap will promote and expand clinical research networks that can rapidly conduct high-quality clinical studies that address multiple research questions. An inventory of existing clinical research networks will explore existing informatics and training infrastructures in order to identify characteristics that promote or inhibit successful network interactivity, productivity and expansion, or broadening of research scope. "Best practices" can then be identified and widely disseminated, further enhancing the efficiency of clinical research networks.
The project will support feasibility studies, selected through a Broad Agency Announcement, aimed at enhancing the clinical research infrastructure through increasing the scope of research activities, increasing participation, and facilitating communication and cooperation among networks. The results of the inventory and the feasibility studies will assist in the development of a National Electronics Clinical Trials and Research (NECTAR) network. NECTAR will provide the informatics infrastructure that will serve as the backbone for interconnected and inter-operable research networks.
The URL for the NIH Roadmap Web site is For more information on the Re-engineering the Clinical Research Enterprise Clinical Research Networks initiative, contact Lawrence Friedman, M.D., National Heart, Lung, and Blood Institute, (301) 496-9899, Further information about NIH can be found at its Web site:


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