Re-engineering the Clinical Research Enterprise

Clinical Research Networks and NECTAR

Overview

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 was designed to 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 (IECRN or Networks for Clinical Research) explored existing informatics and training infrastructures in order to identify characteristics that promoted or inhibited successful network interactivity, productivity and expansion. "Best practices" have been identified which can be disseminated to further enhance the efficiency of clinical research networks.

The project supported 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 which was designed to assist in the development of a National Electronics Clinical Trials and Research (NECTAR) network. NECTAR was thought to provide the informatics infrastructure to serve as the backbone for interconnected and inter-operable research networks.

A Clinical Research Network (CRN) Communications Committee was established to disseminate accomplishments of the NIH Roadmap Feasibility of Integrating and Expanding the Clinical Research Network to the broader research community. The CRN Communications Committee target audience will focus not only on the Principal Investigators in research networks but will include the interdisciplinary groups that represent those clinicians “in the research field.”

For more information on the Re-engineering the Clinical Research Enterprise Clinical Research Networks initiative, contact Dr. Jody Sachs, National Center for Research Resources, (301) 435-0802, sachsjg@mail.nih.gov.

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