A Paradox-based data collection and management system for multi-center randomized clinical trials
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Mazen Abdellatif1, Domenic J Reda
1Hines VA Cooperative Studies Program Coordinating Center (151K), P.O. Box 5000, 5th Ave. and Roosevelt Rd. Bldg. 1, Rm. B240, Hines, IL 60141-5000, USA. abdellat@research.hines.med.va.gov
Abstract:
We have developed a Paradox-based data collection and management system for large-scale multi-site randomized clinical trials. The system runs under Windows operating system and integrates Symantec pcAnywhere32 telecommunications software for data transmission and remote control sessions, PKZIP utility for the compression/decompression of transmitted data, and Stat/Transfer for exporting the centralized Paradox database for analyses. We initially developed this system for VA Cooperative Study #399 'The Effect of Antiarrhythmic Therapy in Maintaining Stability of Sinus Rhythm in Atrial Fibrillation', which collects over 1000 variables on 706 patients at 20 sites. Patient intake for this 5-year study began in March of 1998. We have also developed an enhanced version of this system, which is being used in the NIH-funded 'Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)' that collects over 1200 variables on 1588 patients at 13 sites. Patient intake for this 4-year study began in October of 2000.
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