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A database system for integrated clinical trial management, control, statistical analysis and ICH-compliant reporting
A Gouveia-Oliveira1, N C Salgado
1Datamedica Ltd., Lisbon, Portugal.
Proceedings. AMIA Symposium
|November 24, 1999
Summary
This study presents an integrated computer system for clinical drug trial management, enhancing data integrity and reporting. The system automates monitoring and statistical analysis, ensuring compliance with international guidelines.
Area of Science:
- Clinical pharmacology
- Biostatistics
- Health informatics
Background:
- Manual clinical trial management is error-prone and causes delays.
- Ensuring data integrity and timely reporting is critical for drug trials.
- Organizations need robust database systems for effective clinical trial conduct.
Purpose of the Study:
- To design and implement an integrated computer system for managing clinical drug trials.
- To automate the generation of monitoring and statistical analysis reports.
- To ensure compliance with international guidelines for clinical trial management.
Main Methods:
- Developed a Windows-based integrated computer system.
- Incorporated third-party software tools.
- Major components include COATI (Control, Assessment and Tracking of Therapeutic Investigations), DART (Data Analysis and Reporting Tool), and PANDA (Data Analysis Package).
Main Results:
- The system is a client-server database application (COATI).
- Automated data abstraction and reporting are performed by DART.
- Automated statistical analysis is conducted by PANDA.
- The system has been in production for two years.
- Successfully used in 15 clinical trials across diverse medical conditions and study designs.
Conclusions:
- The integrated system effectively manages and controls multiple clinical drug trials.
- Automated report generation ensures compliance with international standards.
- The system enhances data integrity and timely reporting in drug development.