Clinical Trials 2009;6(1):67-75 [doi: 10.1177/1740774508100983].
Jeng-Jong Pan, PhD (Center for the Clinical Trials Network, NIDA), Meredith L. Nahm, MS, CCDM (CTN Data and Statistics Center), Paul Wakim, PhD (Center for the Clinical Trials Network, NIDA), Carol Cushing, BBA, RN (Center for the Clinical Trials Network, NIDA), Lori Poole (CTN Data and Statistics Center), Betty Tai, PhD (Center for the Clinical Trials Network, NIDA), Carl F. Pieper, DPH (Center for the Clinical Trials Network, NIDA).
Clinical trial networks (CTNs) were created to provide a sustaining infrastructure for the conduct of multisite clinical trials. As such, they must withstand changes in membership. Centralization of infrastructure including knowledge management, portfolio management, information management, process automation, work policies, and procedures in clinical research networks facilitates consistency and ultimately research. In 2005, the National Institute on Drug Abuse (NIDA) CTN transitioned from a distributed data management model to a centralized informatics infrastructure to support the network's trial activities and administration. Centralization has provided the CTN with integrated trial status reporting and the first standards-based public data share. A preliminary cost-benefit analysis showed a 50% reduction in data management cost per study participant over the life of a trial. Post centralization data management operations are more efficient and less costly, with higher data quality. This article describes and evaluates the CTN's centralized informatics infrastructure and discusses the challenges to inform others considering such an endeavor. (Article (Peer-Reviewed), PDF, English, 2009)
Keywords: Clinical trials - Methods | Cost-effectiveness | Data management | National Drug Abuse Treatment Clinical Trials Network | NIDA Data Share | Clinical Trials (journal)
Document No: 345, PMID: 19254937, PMCID: PMC2962616
Submitted by CTN Dissemination Librarians, 3/4/2009.