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Lessons From the Clinical Research Networks Initiative

Robert L. Williams, MD, MPH; Stephen B. Johnson, PhD; Sarah M. Greene, MPH; Eric B. Larson, MD, MPH; Lee A. Green, MD, MPH; Alan Morris, MD; Dennis Confer, MD; Gregory Reaman, MD; Rosemary Madigan, RN, MPH; James Kahn, MD; for the Principal Investigators of the Clinical Research Networks Initiative

Arch Intern Med. 2008;168(17):1919-1925.

Background  The National Institutes of Health (NIH) Roadmap for Medical Research aims to increase the efficiency and speed of clinical research. We report results and lessons learned from a key component of the Roadmap, the Clinical Research Networks initiative.

Methods  Twelve diverse, experienced, large, clinical research networks were funded for 3 years to develop strategies for integrating, expanding, and increasing the interoperability of clinical research networks in support of the Roadmap goals. Network leaders met periodically in person and by teleconference to describe common challenges encountered and solutions used for expansion and increased interoperability.

Results  These networks developed innovative solutions to technical challenges, including strategies for interoperability of information systems and management of complex information system technologies (eg, "brokering" to address data system incompatibility, data transfer, and security requirements), and solutions to human factor challenges at the individual, group, intraorganizational, and interorganizational levels (eg, applying collaborative organizing and decision-making processes based on key principles).

Conclusions  These solutions can provide guidance to existing and future clinical research networks, particularly those forming as part of the NIH Clinical Translation Science Award program. Remaining technical and human factor challenges, however, as well as the largely unmet need for consistent funding for network infrastructure and maintenance, stand in the way of fulfilling the vision of a robust future role for clinical research networks.

Author Affiliations: Department of Family and Community Medicine, University of New Mexico, Albuquerque (Dr Williams); Department of Biomedical Informatics, Columbia University, New York, New York (Dr Johnson); The Center for Health Studies, Group Health, Seattle, Washington (Ms Greene and Dr Larson); Department of Family Medicine, University of Michigan, Ann Arbor (Dr Green); Pulmonary/Critical Care Division, Sorenson Heart-Lung Center, Intermountain Medical Center, and University of Utah, Salt Lake City (Dr Morris); National Marrow Donor Program, Minneapolis, Minnesota (Dr Confer); Department of Pediatrics, George Washington University School of Medicine and Health Sciences, Bethesda, Maryland (Dr Reaman); Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia (Ms Madigan); and Department of Medicine, University of California, San Francisco (Dr Kahn).