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A Paradox-based data collection and management system for multi-center randomized clinical trials.
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
Computer Methods and Programs in Biomedicine
|February 6, 2004
Summary
A new Paradox-based system efficiently manages data for large, multi-site randomized clinical trials. This technology supports complex studies, ensuring reliable data collection and analysis for improved research outcomes.
Area of Science:
- Clinical Informatics
- Data Management Systems
- Randomized Clinical Trials
Background:
- Large-scale randomized clinical trials require robust data collection and management systems.
- Multi-site trials present unique challenges in data integration and standardization.
- Existing systems may not adequately support the complexity of modern clinical research.
Purpose of the Study:
- To develop and implement a Paradox-based data collection and management system for large-scale, multi-site randomized clinical trials.
- To enhance data integrity, transmission efficiency, and analytical accessibility in clinical research.
- To provide a scalable solution adaptable to diverse trial requirements.
Main Methods:
- Development of a centralized Paradox database system.
- Integration of Symantec pcAnywhere32 for secure data transmission and remote control.
- Utilization of PKZIP for data compression and Stat/Transfer for database export for analysis.
- System implementation in VA Cooperative Study #399 and NIH-funded GAIT trial.
Main Results:
- The system successfully manages large volumes of data (over 1000 variables) across multiple sites (20 sites in one study).
- Efficient data collection and transmission were achieved, supporting studies with hundreds of patients.
- The system demonstrated adaptability and scalability through its use in two distinct large-scale trials.
Conclusions:
- A Paradox-based system provides an effective solution for managing complex data in multi-site randomized clinical trials.
- The integrated software components ensure secure data handling, efficient transmission, and streamlined analysis.
- This data management approach supports the successful execution of large clinical research studies.