Patterns of Clinical Trial Eligibility Criteria

  • Krystyna Milian
  • Annette ten Teije
  • Anca Bucur
  • Frank van Harmelen
Part of the Lecture Notes in Computer Science book series (LNCS, volume 6924)


Medical research would benefit from automatic methods that support eligibility evaluation for patient enrollment in clinical trials and design of eligibility criteria. In this study we addressed the problem of formalizing eligibility criteria. By analyzing a large set of breast cancer clinical trials we derived a set of patterns, that capture typical structure of conditions, pertaining to syntax and semantics. We qualitatively analyzed their expressivity and evaluated coverage using regular expressions, running experiments on a few thousands of clinical trials also related to other diseases. Based on an early evaluation we conclude that derived patterns cover the language of eligibility criteria to a large extent and may serve as a semi-formal representation. We expect that extending the presented method for pattern recognition with recognition of ontology concepts will facilitate generating computable queries and automated reasoning for various applications.


eligibility criteria patterns of eligibility criteria regular expressions for eligibility criteria formalization of eligibility criteria 


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Trialx (June 2010),
  2. 2.
    Clinicaltrials (2011),
  3. 3.
    Neo altto (neoadjuvant lapatinib and/or trastuzumab treatment optimisation) study (2011),
  4. 4.
    Topoisomerase ii alpha gene amplification and protein overexpression predicting efficacy of epirubicin (top) (2011),
  5. 5.
    Aronson, A.R.: Metamap: Mapping text to the umls metathesaurus. In: Proceedings AMIA Symposium (2001)Google Scholar
  6. 6.
    Cunningham, H., Maynard, D., Bontcheva, K., Tablan, V.: GATE: A framework and graphical development environment for robust NLP tools and applications. In: Proceedings of the 40th Anniversary Meeting of the Association for Computational Linguistics (2002)Google Scholar
  7. 7.
    Medlock, S., Opondo, D., Eslami, S., Askari, M., Wierenga, P., de Rooij, S.E., Abu-Hanna, A.: Lerm (logical elements rule method): A method for assessing and formalizing clinical rules for decision support. International Journal of Medical Informatics 80(4), 286–295 (2011)CrossRefGoogle Scholar
  8. 8.
    Ohno-Machado, L., Wang, S., Mar, P., Boxwala, A.: Decision support for clinical trial eligibility determination in breast cancer. In: Proceedings AMIA Symposium (1999)Google Scholar
  9. 9.
    Ross, J., Tu, S.W., Carini, S., Sim, I.: Analysis of eligibility criteria complexity in clinical trials. In: AMIA Summits on Translational Science Proceedings (2010)Google Scholar
  10. 10.
    Sordo, M., Ogunyemi, O., Boxwala, A.A., Greenes, R.A.: Software specifications for gello: An object-oriented query and expression language for clinical decision support. Technical report, Decision Systems Group, Brigham & Women’s Hospital, Harvard Medical School, Boston, MA (2003)Google Scholar
  11. 11.
    Tu, S., Peleg, M., Carini, S., Rubin, D., Sim, I.: Ergo: A templatebased expression language for encoding eligibility criteria. Technical report (2009)Google Scholar
  12. 12.
    Tu, S.W., Kemper, C.A., Lane, N.M., Carlson, R.W., Musen, M.A.: A methodology for determining patients eligibility for clinical trials. Methods of Information in Medicine (1993)Google Scholar
  13. 13.
    Wang, S., Ohno-Machado, L., Mar, P., Boxwala, A., Greenes, R.: Enhancing arden syntax for clinical trial eligibility criteria. In: Proceedings AMIA Symposium (1999)Google Scholar
  14. 14.
    Weng, C., Tu, S.W., Sim, I., Richesson, R.: Formal representations of eligibility criteria: A literature review. Journal of Biomedical Informatics (2009)Google Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2012

Authors and Affiliations

  • Krystyna Milian
    • 1
  • Annette ten Teije
    • 1
  • Anca Bucur
    • 2
  • Frank van Harmelen
    • 1
  1. 1.Vrije UniversiteitAmsterdamThe Netherlands
  2. 2.Philips ResearchThe Netherlands

Personalised recommendations