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Economic Analysis of Centralized vs. Decentralized Electronic Data Capture in Multi-Center Clinical Studies

BACKGROUND
New data management models are emerging in multi-center clinical studies. We evaluated the incremental costs associated with decentralized vs. centralized models.


METHODS
We developed clinical research network economic models to evaluate three data management models: centralized, decentralized with local software, and decentralized with shared database. Descriptive information from three clinical research studies served as inputs for these models.


MAIN OUTCOME MEASURES
The primary outcome was total data management costs. Secondary outcomes included: data management costs for sites, local data centers, and central coordinating centers.


RESULTS
Both decentralized models were more costly than the centralized model for each clinical research study: the decentralized with local software model was the most expensive. Decreasing the number of local data centers and case book pages reduced cost differentials between models.


CONCLUSION
Decentralized vs. centralized data management in multi-center clinical research studies is associated with increases in data management costs.