Comparison of paper-based and electronic data collection process in clinical trials: costs simulation study

Area of Science:

• Health Informatics
• Clinical Trial Management
• Process Modeling

Background:

• Clinical trials traditionally rely on paper-based data collection (PDC).
• Electronic data collection (EDC) presents an internet-based alternative for direct data entry by investigators.
• Viewing clinical trials as a business process allows for detailed cost analysis.

Purpose of the Study:

• To model both paper-based data collection (PDC) and electronic data collection (EDC) processes in clinical trials.
• To estimate and compare the cost differences between PDC and EDC for a sample clinical trial.
• To identify key subprocesses contributing to cost variations.

Main Methods:

• Utilized the Extended Event-driven Process Chains (eEPC) modeling technique for both PDC and EDC.
• Assigned cost functions to each process function, incorporating parameters like effort, staff prices, and data quality.
• Estimated parameter values and performed cost calculations for a sample clinical trial.

Main Results:

• Identified data gathering, monitoring, and data management as key subprocesses with significant cost and duration differences.
• The data management subprocess showed the most substantial difference between PDC and EDC.
• For the sample trial, EDC decreased data collection costs by 55%.

Conclusions:

• The EDC process offers substantial cost reductions compared to PDC in clinical trials.
• Estimated savings with EDC range from 49% to 62% based on parameter variations.
• EDC streamlines data collection, particularly in the data management phase, leading to greater efficiency and cost-effectiveness.