Standardizing clinical trials workflow representation in UML for international site comparison.
Abstract
BACKGROUND: With the globalization of clinical trials, a growing emphasis has been
placed on the standardization of the workflow in order to ensure the reproducibility
and reliability of the overall trial. Despite the importance of workflow evaluation,
to our knowledge no previous studies have attempted to adapt existing modeling languages
to standardize the representation of clinical trials. Unified Modeling Language (UML)
is a computational language that can be used to model operational workflow, and a
UML profile can be developed to standardize UML models within a given domain. This
paper's objective is to develop a UML profile to extend the UML Activity Diagram schema
into the clinical trials domain, defining a standard representation for clinical trial
workflow diagrams in UML. METHODS: Two Brazilian clinical trial sites in rheumatology
and oncology were examined to model their workflow and collect time-motion data. UML
modeling was conducted in Eclipse, and a UML profile was developed to incorporate
information used in discrete event simulation software. RESULTS: Ethnographic observation
revealed bottlenecks in workflow: these included tasks requiring full commitment of
CRCs, transferring notes from paper to computers, deviations from standard operating
procedures, and conflicts between different IT systems. Time-motion analysis revealed
that nurses' activities took up the most time in the workflow and contained a high
frequency of shorter duration activities. Administrative assistants performed more
activities near the beginning and end of the workflow. Overall, clinical trial tasks
had a greater frequency than clinic routines or other general activities. CONCLUSIONS:
This paper describes a method for modeling clinical trial workflow in UML and standardizing
these workflow diagrams through a UML profile. In the increasingly global environment
of clinical trials, the standardization of workflow modeling is a necessary precursor
to conducting a comparative analysis of international clinical trials workflows.
Type
Journal articleSubject
AlgorithmsBrazil
Clinical Trials as Topic
Computer Simulation
Humans
International Cooperation
Medical Oncology
Models, Theoretical
Programming Languages
Reference Standards
Rheumatology
Workflow
Permalink
https://hdl.handle.net/10161/4582Published Version (Please cite this version)
10.1371/journal.pone.0013893Publication Info
de Carvalho, Elias Cesar Araujo; Jayanti, Madhav Kishore; Batilana, Adelia Portero;
Kozan, Andreia MO; Rodrigues, Maria J; Shah, Jatin; ... Pietrobon, Ricardo (2010). Standardizing clinical trials workflow representation in UML for international site
comparison. PLoS One, 5(11). pp. e13893. 10.1371/journal.pone.0013893. Retrieved from https://hdl.handle.net/10161/4582.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
Collections
More Info
Show full item record
Articles written by Duke faculty are made available through the campus open access policy. For more information see: Duke Open Access Policy
Rights for Collection: Scholarly Articles
Works are deposited here by their authors, and represent their research and opinions, not that of Duke University. Some materials and descriptions may include offensive content. More info