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Form Follows Function

Model-Driven Engineering for Clinical Trials

  • Conference paper

Part of the book series: Lecture Notes in Computer Science ((LNPSE,volume 7151))

Abstract

We argue that, for certain constrained domains, elaborate model transformation technologies—implemented from scratch in general-purpose programming languages—are unnecessary for model-driven engineering; instead, lightweight configuration of commercial off-the-shelf productivity tools suffices. In particular, in the CancerGrid project, we have been developing model-driven techniques for the generation of software tools to support clinical trials. A domain metamodel captures the community’s best practice in trial design. A scientist authors a trial protocol, modelling their trial by instantiating the metamodel; customized software artifacts to support trial execution are generated automatically from the scientist’s model. The metamodel is expressed as an XML Schema, in such a way that it can be instantiated by completing a form to generate a conformant XML document. The same process works at a second level for trial execution: among the artifacts generated from the protocol are models of the data to be collected, and the clinician conducting the trial instantiates such models in reporting observations—again by completing a form to create a conformant XML document, representing the data gathered during that observation. Simple standard form management tools are all that is needed. Our approach is applicable to a wide variety of information-modelling domains: not just clinical trials, but also electronic public sector computing, customer relationship management, document workflow, and so on.

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References

  1. Blair, T.: Modernising government. UK Cabinet Office white paper CM 4310, UK Government (March 1999), http://www.archive.official-documents.co.uk/document/cm43/4310/4310.htm

  2. Brenton, J., Caldas, C., Davies, J., Harris, S., Maccallum, P.: CancerGrid: Developing open standards for clinical cancer informatics. In: UK E-Science All Hands Meeting (2005)

    Google Scholar 

  3. Brenton, J., Davies, J., Gibbons, J., Harris, S.: Accelerating cancer research using semantics-driven technology. In: Microsoft eScience Workshop (December 2008)

    Google Scholar 

  4. Brooks Jr., F.P.: The Mythical Man-Month. Addison-Wesley (1975)

    Google Scholar 

  5. Calinescu, R.: Model-based SOA generation for cancer clinical trials. In: Skar, L.A., Bjerkestrand, A.A. (eds.) OOPSLA Workshop on Service-Oriented Architectures, Portland, Oregon, pp. 57–71 (2006)

    Google Scholar 

  6. Calinescu, R., Harris, S., Gibbons, J., Davies, J., Toujilov, I., Nagl, S.: Model-driven architecture for cancer research. In: Software Engineering and Formal Methods, pp. 59–68 (September 2007)

    Google Scholar 

  7. CancerGrid website, http://www.cancergrid.org/

  8. CancerGrid metadata registry (cgMDR), http://www.cancergrid.org/index.php?option=com_content&id=8:mdrarticle

  9. Cong, G., Fan, W., Jia, X., Ma, S.: PRATA: A system for XML publishing, integration and view maintenance. In: UK e-Science All Hands Meeting, pp. 432–435 (2006)

    Google Scholar 

  10. Crichton, C., Davies, J., Gibbons, J., Harris, S., Shukla, A.: Semantic frameworks for e-Government. In: Pardo, T., Janowski, T. (eds.) International Conference on Theory and Practice of Electronic Governance (ICEGOV), pp. 30–39 (2007)

    Google Scholar 

  11. Crichton, C., Davies, J., Gibbons, J., Harris, S., Shukla, A., Tsui, A.: Semantics-driven development for electronic government applications. In: HICSS Workshop on Electronic Government (2009)

    Google Scholar 

  12. Crichton, C., Davies, J., Gibbons, J., Harris, S., Tsui, A., Brenton, J.: Metadata-driven software for clinical trials. In: ICSE Workshop on Software Engineering in Health Care. IEEE (May 2009)

    Google Scholar 

  13. Davies, J., Gibbons, J., Harris, S., Metz, J., Pollard, A.J., Snape, M.: Model-driven support for a vaccine study in Kathmandu. In: Microsoft eScience Workshop (2009)

    Google Scholar 

  14. Davies, J., Gibbons, J., Harris, S., Warzel, D.: Evolving health informatics: Semantic frameworks and metadata-driven architectures. In: Microsoft eScience Workshop (2008)

    Google Scholar 

  15. Davies, J., Harris, S., Crichton, C., Shukla, A., Gibbons, J.: Metadata standards for semantic interoperability in electronic government. In: International Conference on Theory and Practice of Electronic Governance (2008)

    Google Scholar 

  16. Earl, H.: Neo-tAnGo: A neoadjuvant study of sequential epirubicin + cyclophosphamide and paclitaxel ± gemcitabine in the treatment of high risk early breast cancer with molecular profiling, proteomics and candidate gene analysis (2007) iSRCTN 78234870, http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=1229

  17. Fegan, G.W., Lang, T.A.: Could an open-source clinical trial data-management system be what we have all been looking for? PLoS Medicine 5(3) (March 2008)

    Google Scholar 

  18. Fowler, M.: Domain Specific Languages. Addison Wesley (2010)

    Google Scholar 

  19. Harris, S., Calinescu, R.: CancerGrid clinical trials model 1.1. Tech. Rep. MRC/1.4.1.3, CancerGrid (2006), http://www.cancergrid.org/index.php?option=com_remository&func=fileinfo&id=185

  20. ISO/IEC JTC1 SC32 WG2: ISO/IEC,11179, Information technology—metadata registries, http://metadata-standards.org/11179/

  21. Kush, R.: Can the protocol be standardised? Tech. rep., Clinical Data Interchange Standards Consortium (2006)

    Google Scholar 

  22. McLaren, I., Wicks, T.: Developing generative frameworks using XML. In: Automated Software Engineering, pp. 368–372 (2001)

    Google Scholar 

  23. Mellor, S.J., Balcer, M.: Executable UML: A Foundation for Model-Driven Architecture. Addison-Wesley (2002)

    Google Scholar 

  24. Microsoft: InfoPath website, http://office.microsoft.com/en-us/infopath/

  25. Microsoft: XML Schema Definition Tool (Xsd.exe) (2009), http://msdn.microsoft.com/en-us/library/x6c1kb0sVS.80.aspx

  26. Miller, J., Mukerji, J.: Model driven architecture: A technical perspective. Tech. Rep. ormsc/2001-07-01, Object Management Group (July 2001)

    Google Scholar 

  27. Moher, D., Schulz, K., Altman, D.G.: The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomised trials. The Lancet, 357 (April 2001)

    Google Scholar 

  28. Poole, C., Earl, H.: NEAT: National breast cancer study of epirubicin plus CMF versus classical CMF adjuvant therapy (2001) iSRCTN 42625759, http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=643

  29. Poole, C., Howard, H., Dunn, J.: tAnGo: A phase III randomized trial of gemcitabine in paclitaxel-containing, epirubicin-based adjuvant chemotherapy for women with early stage breast cancer (2004) iSRCTN 51146252, http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=661

  30. Sierra, J.L., Fernández-Valmayor, A., Fernández-Manjón, B.: A document-oriented paradigm for the construction of content-intensive applications. Computer Journal 49(5), 562–584 (2006)

    Article  Google Scholar 

  31. Steele, G.L.: Objects have not failed, position statement for OOPSLA panel (2002)

    Google Scholar 

  32. Stell, A., Sinnott, R., Ajayi, O.: Supporting the clinical trial recruitment process through the grid. In: UK e-Science All Hands Meeting, pp. 61–68 (2006)

    Google Scholar 

  33. Sullivan, L.: The tall office building artistically considered. Lippincott’s Magazine (March 1896)

    Google Scholar 

  34. University of Birmingham School of Medicine: How Birmingham researchers are taking a measured look at medical treatments. Medlines 4 (July 1997), http://www.publications.bham.ac.uk/medlines/1997b/a_medpg3.htm

  35. US National Cancer Institute: caCORE software development kit (2006), http://ncicb.nci.nih.gov/infrastructure/cacoresdk

  36. US National Cancer Institute: Cancer Biomedical Informatics Grid (2006), https://cabig.nci.nih.gov/

  37. Wong, P.Y.H., Gibbons, J.: A process-algebraic approach to workflow specification and refinement. In: Software Composition (2007)

    Google Scholar 

  38. Wong, P.Y.H., Gibbons, J.: On Specifying and Visualising Long-Running Empirical Studies. In: Vallecillo, A., Gray, J., Pierantonio, A. (eds.) ICMT 2008. LNCS, vol. 5063, pp. 76–90. Springer, Heidelberg (2008)

    Chapter  Google Scholar 

  39. Wong, P.Y.H., Gibbons, J.: Formalisations and applications of BPMN. Science of Computer Programming 76, 633–650 (2011)

    Article  MATH  Google Scholar 

  40. Wong, P.Y.H., Gibbons, J.: Property specifications for workflow modelling. Science of Computer Programming 76(10), 942–967 (2011)

    Article  MATH  Google Scholar 

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Davies, J., Gibbons, J., Calinescu, R., Crichton, C., Harris, S., Tsui, A. (2012). Form Follows Function. In: Liu, Z., Wassyng, A. (eds) Foundations of Health Informatics Engineering and Systems. FHIES 2011. Lecture Notes in Computer Science, vol 7151. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-32355-3_2

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  • DOI: https://doi.org/10.1007/978-3-642-32355-3_2

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-32354-6

  • Online ISBN: 978-3-642-32355-3

  • eBook Packages: Computer ScienceComputer Science (R0)

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