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The relational database model and multiple multicenter clinical trials.

B A Blumenstein¹

¹Southwest Oncology Group Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, Washington 98104.

Controlled Clinical Trials

|December 1, 1989

Summary

This summary is machine-generated.

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The Southwest Oncology Group (SWOG) uses a relational database management system (RDBMS) for flexible clinical trial data management. This system supports multiple users and interactive data operations, enhancing software development and maintenance.

Area of Science:

Biomedical Informatics
Clinical Trial Management
Database Systems

Background:

Managing complex data from multiple clinical trials presents significant challenges.
Traditional data models may lack the flexibility required for diverse research needs.

Purpose of the Study:

To evaluate the suitability of a relational database management system (RDBMS) for clinical trial data management.
To explore the advantages and disadvantages of the relational model compared to hierarchical models.

Main Methods:

The Southwest Oncology Group (SWOG) implemented an RDBMS for its clinical trial data.
Developed data operations software in a compiled language to interact with the RDBMS.
Focused on accommodating multiple entity types (patients, studies, participants).

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Main Results:

The relational model offers inherent flexibility and natural accommodation of multiple entity types.
Tradeoffs include increased computing cycles and procedural complexity for referential integrity.
The RDBMS serves as a platform for developing interactive data operations software.

Conclusions:

Relational database management systems provide a flexible and robust platform for clinical trial data.
The chosen RDBMS facilitates the development and maintenance of essential data operations software.
SWOG's approach demonstrates the practical benefits of RDBMS in multi-trial environments.