Two CDISC Use Cases and Further Thoughts on Medical Devices
At the November 2014 CDISC International Interchange, held in Bethesda, Maryland, there was a session that showcased three somewhat unusual implementations of CDISC standards. The first use case was presented by Rafael Smets, who described the use of CDASH and SDTM in setting up a safety data monitoring system. This presentation has been well summarized in “Overview on CDISC for Safety Monitoring, Devices and Epidemiology…” on pg. 15 of the November 2014 CDISC Newsletter. Here, we will explore the other two presentations, which were focused on devices and on epidemiology.
Clinical and Epidemiological Research Yoshiteru Chiba of the University Hospital Medical Information Network (UMIN Center) at the University of Tokyo Hospital presented a talk about UMIN’s project named “Development, Operation and Evaluation of Clinical and Epidemiological Research Data Using CDISC ODM.” Two additional authors were Takahiro Kiuchi, M.D., Ph.D., and Hirono Ishikawa, Ph.D. The goal of this project was to use ODM to retrieve data from multiple studies or subsets of studies that reside in different structures in different locations, and store the resulting data in a flexible, ODM-based cloud environment.
UMIN provides the technology infrastructure and information services and support for a wide variety of activities, including clinical education and training and evaluation systems, glossaries, clinical trials registries, patient recruitment databases, and, of course, many kinds of clinical and epidemiological research. A measure of its success is that, between its inception in 2000 and 2014, active projects per year have climbed from zero to over 200, and registered users have topped 3 million.
Because of the large quantity and variety of the data, this environment provides opportunities for combining and using data in ways that go beyond traditional silo-bound analyses. UMIN’s project studied challenging exploratory research drawing data from different databases, recombining them and extracting further meaning. The resulting system allow users to employ ODM syntax to search for particular data fields they want and returns all the databases that contain that field. Based on those results, users can choose to retrieve selected or all records from one or many studies, which are then stored in the cloud in ODM format for use in further research. In addition, the project concluded that the same CDISC standards could be used for data submitted to academic publications as well as
Strength through Collaboration
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