Design-a-trial: A rule-based decision support system for clinical trial design

Knowledge-Based Systems

Volumn 17, Issue 2-4, 2004, Pages 121-129

  Nammuni, K ^a   Pickering, C ^b   Modgil, S ^c   Montgomery, A ^b   Hammond, P ^c   Wyatt, J C ^d   Altman, D G ^e   Dunlop, R ^b   Potts, H W W ^f  

^a UNIVERSITY OF SOUTHAMPTON   (United Kingdom)

^b InferMed Ltd   (United Kingdom)

^c UNIVERSITY COLLEGE LONDON   (United Kingdom)

^d Natl Inst for Clinical Excellence   (United Kingdom)

^e UNIVERSITY OF OXFORD   (United Kingdom)

^f UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

Ethics application; Randomised controlled clinical trial; Trial protocol

Indexed keywords

ARTIFICIAL INTELLIGENCE; COMPUTER PROGRAMMING; DATA ACQUISITION; DRUG PRODUCTS; INFORMATION RETRIEVAL SYSTEMS; MEDICAL IMAGING; PROBLEM SOLVING; STATISTICAL METHODS;

ETHICS APPLICATION; RANDOMISED CONTROLLED CLINICAL TRIAL (RCT); TRIAL PROTOCOL;

DECISION SUPPORT SYSTEMS;

EID: 3242724981     PISSN: 09507051     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.knosys.2004.03.007     Document Type: Conference Paper

References (36)

1. Raven A. Consider it pure joy. third ed. An Introduction to Clinical Trials. 1997;Cambridge Healthcare Research Ltd, Cambridge.
2. US Food and Drug Administration, ICH E6: Good Clinical Practice: Consolidated Guideline 1996, Date accessed: 13th June 2003, www.fda.gov/cder/ guidance/959fnl.pdf .
3. Medical Research Council, MRC Guidelines for Good Clinical Practice in Clinical Trials 1998, Date accessed: 13th June 2003, www.mrc.ac.uk/pdf-ctg.pdf .
4. Department of Health, Research Governance Framework for England, Date accessed: 13th June 2003, www.doh.gov.uk/research/rd3/nhsrandd/ researchgovernance.htm .
5. The World Medical Association, Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, Date accessed: 13th June 2003, www.wma.net/e/policy/b3.htm .
6. Altman D.G. Practical Statistics for Medical Research. 1991;Chapman and Hall, London.
7. Wyatt J.C. Clinical Knowledge and Practice in the Information Age: a Handbook for Health Professionals. 2001;The Royal Society of Medicine Press Limited, London.
8. CONSORT Homepage, Date accessed: 15th June 2003, www.consort-statement. org/ .
9. Altman D.G., Dore C.J. Randomisation and baseline comparisons in clinical trials. Lancet. 335:1990;149-153.
10. Wyatt J.C., Altman D.G., Pantin C. Design-a-Trial: a knowledge-based aid for writers of clinical trial protocols. Reichert A., Sadan S. Proceedings of Medical Informatics Europe'93, Jerusalem (ISBN 965-294-091-7). 1993;68-73 Freund Ltd, London.
11. Wyatt J.C., Altman D.G., Heathfield H., et al. Development of Design-a-Trial: a knowledge-based critiquing system for authors of clinical trial protocols. Comput. Meth. Programs Biomed. 43:1994;283-291.
12. H.W.W. Potts, J.C. Wyatt, S. Modgil, et al., Design-a-Trial: A Knowledge-based System to Support Clinical Trial Designers, Sept. 1999: ISCB-GMDS-99 Abstract Volume, 339, Abstract of presentation at ISCB-GMDS-99, Heidelberg.
13. Modgil S., Hammond P., Wyatt J.C. The Design-a-Trial project: developing a knowledge-based tool for authoring clinical trial protocols. Heller B., Löffler H., Musen M. Computer-Based Support for Clinical Guidelines and Protocols: In Proceedings of EWGLP-2000 (Studies in Health Technology and Informatics. vol. 83:2001;71-85 IOS press, Amsterdam.
14. Modgil S., Hammond P. Generating symbolic and natural language partial solutions for inclusion in medical plans. Quaglini S., Barahona P., Andreassen S. Proceedings of 8th Conference on Artificial Intelligence in Medicine in Europe, AIME, Cascais Portugal, July, LNAI, 2101. 2001;239-248.
15. Modgil S., Hammond P. Decision support tools for clinical trial design. Artif. Intell. Med. 27:2003;181-200.
16. Potts H.W.W., Wyatt J.C., Altman D.G. Challenges in evaluating complex decision support systems: lessons from Design-a-Trial. Quaglini S., Barahona P., Andreassen S. Artificial Intelligence in Medicine. 2001;453-456 Springer, Heidelberg.
17. Sterling L., Shapiro E. The Art of Prolog. second ed. Advanced Programming Techniques. 1994;MIT Press, Cambridge, MA. (March 10, 1994), ISBN: 0262691639.
18. Microsoft, Microsoft.NET, Date accessed: 13th June 2003, www.microsoft.com/net/ .
19. LPA, Win-Prolog 4.3, Date accessed: 13th June 2003, www.lpa.co.uk/win.htm .
20. SafeScript Ltd - The World Standard Drug Database, Date accessed: 13th June 2003, //admin.safescript.com/ .
21. InferMed Ltd, Homepage. Date accessed: 13th June, www.infermed.com .
22. CDISC, Homepage, Date accessed: 16th June 2003, www.cdisc.org/ .
23. Balena F. Programming Microsoft® Visual Basic® .NET (Core Reference). first ed. 2002;Microsoft Press. ISBN: 0-7356-1375-3.
24. Shneiderman B. Eight Golden Rules of Interface Design. third ed. In Designing the User Interface. 1997;Addison-Wesley, London.
25. Smith S.L., Mosier J.N. Design guidelines for user-system interface software. Technical Report ESD-TR-84-190. 1984;The Mitre Corporation, Bedford, MA.
26. Egger M., Jüni P., Bartlett C. Value of flow diagrams in reports of randomized controlled trials. Am. Med. Assoc. 285:2001;1996-1999.
27. Ernst and Young, Eighth Annual European Life Sciences Report, Date accessed: 16th June 2003, www.ey.com/global/Content.nsf/UK/ HS_-_Library_-_Integration .
28. Pharsight, Solutions for Clinical Development: The Need for Computer-Assisted Trial Design (CATD), Date accessed: 13th June 2003, www.pharsight.com/solutions/soln_catd_need.php.
29. Haag U. Knowledge representation for computer-aided planning of controlled clinical trials: the PaTriCIa project. Methods Inf. Med. 36:(3):1997;172-178.
30. D.L. Rubin, J. Gennari, M.A. Musen, Knowledge representation and tool support for critiquing clinical trial protocols, SMI Report Number: SMI-2000-0844.
31. The Royal Free Clinical Trials Centre, Homepage, Date accessed: 16th June 2003, www.clinical-trials-centre.org .
32. Scirex Corporation, Homepage, Date accessed: 16th June 2003, www.scirex.com .
33. Clinical Evidence, Homepage, Date accessed: 16th June 2003, www.clinicalevidence.com/lpBinCE/lpext.dll?f=templatesandfn=main-h.htmand2.0 .
34. Centre for Statistics in Medicine, HomePage, Date accessed: 16th June 2003, http://www.ihs.ox.ac.uk/csm/ .
35. University College London Department of Statistical Science, Date accessed: 16th June 2003, http://www.ucl.ac.uk/Stats/ .
36. Cochrane Collaboration, Homepage, Date accessed: 16th June 2003, www.cochrane.org .