Skip to main content

Design considerations, architecture, and use of the Mini-Sentinel distributed data system.

Publication ,  Journal Article
Curtis, LH; Weiner, MG; Boudreau, DM; Cooper, WO; Daniel, GW; Nair, VP; Raebel, MA; Beaulieu, NU; Rosofsky, R; Woodworth, TS; Brown, JS
Published in: Pharmacoepidemiol Drug Saf
January 2012

PURPOSE: We describe the design, implementation, and use of a large, multiorganizational distributed database developed to support the Mini-Sentinel Pilot Program of the US Food and Drug Administration (FDA). As envisioned by the US FDA, this implementation will inform and facilitate the development of an active surveillance system for monitoring the safety of medical products (drugs, biologics, and devices) in the USA. METHODS: A common data model was designed to address the priorities of the Mini-Sentinel Pilot and to leverage the experience and data of participating organizations and data partners. A review of existing common data models informed the process. Each participating organization designed a process to extract, transform, and load its source data, applying the common data model to create the Mini-Sentinel Distributed Database. Transformed data were characterized and evaluated using a series of programs developed centrally and executed locally by participating organizations. A secure communications portal was designed to facilitate queries of the Mini-Sentinel Distributed Database and transfer of confidential data, analytic tools were developed to facilitate rapid response to common questions, and distributed querying software was implemented to facilitate rapid querying of summary data. RESULTS: As of July 2011, information on 99,260,976 health plan members was included in the Mini-Sentinel Distributed Database. The database includes 316,009,067 person-years of observation time, with members contributing, on average, 27.0 months of observation time. All data partners have successfully executed distributed code and returned findings to the Mini-Sentinel Operations Center. CONCLUSION: This work demonstrates the feasibility of building a large, multiorganizational distributed data system in which organizations retain possession of their data that are used in an active surveillance system.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Pharmacoepidemiol Drug Saf

DOI

EISSN

1099-1557

Publication Date

January 2012

Volume

21 Suppl 1

Start / End Page

23 / 31

Location

England

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Software
  • Program Development
  • Product Surveillance, Postmarketing
  • Pilot Projects
  • Pharmacology & Pharmacy
  • Models, Theoretical
  • Humans
  • Feasibility Studies
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Curtis, L. H., Weiner, M. G., Boudreau, D. M., Cooper, W. O., Daniel, G. W., Nair, V. P., … Brown, J. S. (2012). Design considerations, architecture, and use of the Mini-Sentinel distributed data system. Pharmacoepidemiol Drug Saf, 21 Suppl 1, 23–31. https://doi.org/10.1002/pds.2336
Curtis, Lesley H., Mark G. Weiner, Denise M. Boudreau, William O. Cooper, Gregory W. Daniel, Vinit P. Nair, Marsha A. Raebel, et al. “Design considerations, architecture, and use of the Mini-Sentinel distributed data system.Pharmacoepidemiol Drug Saf 21 Suppl 1 (January 2012): 23–31. https://doi.org/10.1002/pds.2336.
Curtis LH, Weiner MG, Boudreau DM, Cooper WO, Daniel GW, Nair VP, et al. Design considerations, architecture, and use of the Mini-Sentinel distributed data system. Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:23–31.
Curtis, Lesley H., et al. “Design considerations, architecture, and use of the Mini-Sentinel distributed data system.Pharmacoepidemiol Drug Saf, vol. 21 Suppl 1, Jan. 2012, pp. 23–31. Pubmed, doi:10.1002/pds.2336.
Curtis LH, Weiner MG, Boudreau DM, Cooper WO, Daniel GW, Nair VP, Raebel MA, Beaulieu NU, Rosofsky R, Woodworth TS, Brown JS. Design considerations, architecture, and use of the Mini-Sentinel distributed data system. Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:23–31.

Published In

Pharmacoepidemiol Drug Saf

DOI

EISSN

1099-1557

Publication Date

January 2012

Volume

21 Suppl 1

Start / End Page

23 / 31

Location

England

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Software
  • Program Development
  • Product Surveillance, Postmarketing
  • Pilot Projects
  • Pharmacology & Pharmacy
  • Models, Theoretical
  • Humans
  • Feasibility Studies