Towards Semantic Interoperability in a Clinical Trials Management System

  • Ravi D. Shankar
  • Susana B. Martins
  • Martin J. O’Connor
  • David B. Parrish
  • Amar K. Das
Part of the Lecture Notes in Computer Science book series (LNCS, volume 4273)

Abstract

Clinical trials are studies in human patients to evaluate the safety and effectiveness of new therapies. Managing a clinical trial from its inception to completion typically involves multiple disparate applications facilitating activities such as trial design specification, clinical sites management, participants tracking, and trial data analysis. There remains however a strong impetus to integrate these diverse applications – each supporting different but related functions of clinical trial management – at syntactic and semantic levels so as to improve clarity, consistency and correctness in specifying clinical trials, and in acquiring and analyzing clinical data. The situation becomes especially critical with the need to manage multiple clinical trials at various sites, and to facilitate meta-analyses on trials. This paper introduces a knowledge-based framework that we are building to support a suite of clinical trial management applications. Our initiative uses semantic technologies to provide a consistent basis for the applications to interoperate. We are adapting this approach to the Immune Tolerance Network (ITN), an international research consortium developing new therapeutics in immune-mediated disorders.

References

  1. 1.
    Rotrosen, D., Matthews, J.B., Bluestone, J.A.: The Immune Tolerance Network: a New Paradigm for Developing Tolerance-Inducing Therapies. J. Allergy Clinical Immunology 110(1), 17–23 (2002)CrossRefGoogle Scholar
  2. 2.
  3. 3.
    Johnson, P.D., Tu, S.W., Musen, M.A., Purves, I.: A Virtual Medical Record for Guideline-Based Decision Support. In: AMIA Annual Symposium, Washington, DC, pp. 294–298 (2001)Google Scholar
  4. 4.
    O’Connor, M.J., Shankar, R.D., Das, A.K.: An Ontology-Driven Mediator for Querying Time-Oriented Biomedical Data. In: 19th IEEE International Symposium on Computer-Based Medical Systems, Salt Lake City, Utah, pp. 264–269 (2006)Google Scholar
  5. 5.
    OWL Specification, http://www.w3.org/2004/OWL/
  6. 6.
  7. 7.
  8. 8.
    Knublauch, H., Fergerson, R.W., Noy, N.F., Musen, M.A., The Protégé, O.W.L.: The Protégé OWL Plugin: An Open Development Environment for Semantic Web applications. In: McIlraith, S.A., Plexousakis, D., van Harmelen, F. (eds.) ISWC 2004. LNCS, vol. 3298, pp. 229–243. Springer, Heidelberg (2004)CrossRefGoogle Scholar
  9. 9.
    O’Connor, M.J., Knublauch, H., Tu, S.W., Grossof, B., Dean, M., Grosso, W.E., Musen, M.A.: Supporting Rule System Interoperability on the Semantic Web with SWRL. In: Gil, Y., Motta, E., Benjamins, V.R., Musen, M.A. (eds.) ISWC 2005. LNCS, vol. 3729, pp. 974–986. Springer, Heidelberg (2005)CrossRefGoogle Scholar
  10. 10.
    Allen, J.F.: Maintaining knowledge about temporal intervals. Communications of the ACM 26(11), 832–843 (1993)CrossRefGoogle Scholar
  11. 11.
  12. 12.
  13. 13.
    Musen, M.A., Tu, S.W., Das, A.K., Shahar, Y.: EON: A component-based approach to automation of protocol-directed therapy. Journal of the American Medical Informatics Association 3(6), 367–388 (1996)Google Scholar
  14. 14.
    Fox, J., Johns, N., Rahmanzadeh, A., Thomson, R.: PROfarma: A method and language for specifying clinical guidelines and protocols. In: Proceedings of Medical Informatics Europe, Amsterdam (1996)Google Scholar
  15. 15.
    Boxwala, A.A., Peleg, M., Tu, S.W., Ogunyemi, O., Zeng, Q.T., Wang, D., Patel, V.L., Greenes, R.A., Shortliffe, E.H.: GLIF3: A Representation Format for Sharable Computer-Interpretable Clinical Practice. Journal of Biomedical Informatics 37(3), 147–161 (2004)CrossRefGoogle Scholar
  16. 16.
    Sim, I., Olasov, B., Carini, S.: The Trial Bank system: capturing randomized trials for evidence-based medicine. In: Proceedings of the AMIA Annual Symposium, p. 1076 (2003)Google Scholar
  17. 17.
    Modgil, S., Hammond, P.: Decision support tools for clinical trial design. Artificial Intelligence in Medicine 27(2), 181–200 (2003)CrossRefGoogle Scholar
  18. 18.
  19. 19.
  20. 20.
  21. 21.
    Wang, H., Rector, A., Drummond, N., et al.: Frames and OWL Side by Side. In: 9th International Protégé Conference, Stanford, CA (2006)Google Scholar
  22. 22.
    Crubezy, M., O’Connor, M.J., Buckeridge, D.L., Pincus, Z.S., Musen, M.A.: Ontology-Centered Syndromic Surveillance for Bioterrorism. IEEE Intelligent Systems 20(5), 26–35 (2005)CrossRefGoogle Scholar
  23. 23.
  24. 24.

Copyright information

© Springer-Verlag Berlin Heidelberg 2006

Authors and Affiliations

  • Ravi D. Shankar
    • 1
  • Susana B. Martins
    • 1
  • Martin J. O’Connor
    • 1
  • David B. Parrish
    • 2
  • Amar K. Das
    • 1
  1. 1.Stanford Medical InformaticsStanford University School of MedicineStanfordUSA
  2. 2.The Immune Tolerance NetworkPittsburgh

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