Operational Data Management within the Clinical Trials Network of the National Institute on Drug Abuse (NIDA CTN)
Year of Publication
20th Annual Conference of the Society for Clinical Data Management
Las Vegas, NV
The Clinical Trials Network (CTN) for the National Institute on Drug Abuse (NIDA) provides a platform in which NIDA, treatment researchers, and community-based service providers work toward new treatment options in community-level clinical practice. The CTN framework consists of thirteen nodes (Regional Research and Training Centers - RRTCs linked with Community-based Treatment programs - CTPs), a Clinical Coordinating Center (CCC), and Data Coordinating Center (DCC). This framework links a variety of CTPs and patient populations throughout the country. Setting up the network in this manner allows the CTN to provide a broad and powerful infrastructure for rapid, multi-site testing of promising science-based therapies and the subsequent delivery of these treatments to patients in community-based treatment. The role of the DCC is to provide statistical and data management support to the network in 7 areas. These tasks are 1) establish and administer a web-based data collection system, 2) support protocol development and perform statistical analyses, 3) review and monitor the quality of study data 4) monitor trial performance 5) prepare reports for and support Data and Safety Monitoring Boards 6) participate in committee and subcommittee calls and meetings 7) provide support in the areas of electronic health records, common data elements and registries. Forming a central data coordinating center provided the ability to monitor for consistency and trends across multiple protocols across many sites at different locations in the country. This presentation will focus on approaches for maximizing data and project management efficiencies. The benefits, challenges, and strategies for effective trial operations will be discussed. Specific speaking points will include structure of the electronic data capture system (EDC), data quality, site monitoring, trial progress monitoring, help desk coordination, training, and data share. Because The EMMES Corporation serves as both the CCC and DSC for this network, specific insights in ways to build an effective team with good communication will be also discussed.