Signposts along the NIH roadmap for reengineering clinical research - Lessons from the Clinical Research Networks Initiative

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 networkswere 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 humanfactor 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.