New England Research Institutes (NERI) proposes to serve as the Data Coordinating Center for the Thalassemia Clinical Research Network to accomplish the following goals: To collaborate with the Steering Committee in the selection of protocols and the design of the clinical trials, specifically providing statistical advice relevant to design, conduct, and analysis; To develop and maintain a data management system for the Network; To develop and maintain a system for tracking all central laboratory specimens; To train trial personnel in all aspects of the trials, conduct site visits, and monitor and document the quality of all data collected; To compile edit, report on, and analyze trial data and collaborate in scientific presentations and publications; and To provide administrative support. Important features of NERI's proposal include: our extensive, highly relevant expertise in multi-site studies of sickle cell disease; clinical trials involving transfusion therapy of patients with sickle cell anemia and interferon treatment for patients with hepatitis C; our in-house expertise in quality of life, health care utilization and cost measurement; our proprietary ADEPT web-based data management system which fully integrates data entry with automated, centralized randomization and protocol and patient tracking; our modular approach to all study protocols; and finally, our proposal to establish in, Year 01, a registry of all thalassemia patients identified, during the funding period, at each of the clinical centers to fully inform all proposed clinical trials in terms of feasibility target population, and science.
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