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Economic analysis of centralized vs. decentralized electronic data capture in multi-center clinical studies.

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1
Duke University, Durham, North Carolina, USA.

Abstract

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.

PMID:
21335692
PMCID:
PMC3506018
[Indexed for MEDLINE]
Free PMC Article
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