title: Economic analysis of centralized vs. decentralized electronic data capture in multi-center clinical studies.
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Decentralized vs. centralized data management in multi-center clinical research studies is associated with increases in data management costs.
authors.affiliation: Duke University, Durham, North Carolina, USA.
authors.forename: Anita
authors.initials: A
authors.lastname: Walden
authors.forename: Meredith
authors.initials: M
authors.lastname: Nahm
authors.forename: M Edwina
authors.initials: ME
authors.lastname: Barnett
authors.forename: Jose G
authors.initials: JG
authors.lastname: Conde
authors.forename: Andrew
authors.initials: A
authors.lastname: Dent
authors.forename: Ahmed
authors.initials: A
authors.lastname: Fadiel
authors.forename: Theresa
authors.initials: T
authors.lastname: Perry
authors.forename: Chris
authors.initials: C
authors.lastname: Tolk
authors.forename: James E
authors.initials: JE
authors.lastname: Tcheng
authors.forename: Eric L
authors.initials: EL
authors.lastname: Eisenstein
mesh_terms: D003365:Costs and Cost Analysis / Q000379:methods; D006751:Hospital Information Systems / Q000191:economics* / Q000458:organization & administration*; D019451:Information Management / Q000458:organization & administration*; D017146:Models, Organizational