2013 Fiscal Year Final Research Report
Development and evaluation of a clinical trial simulation system by the second use of EMRs
| Project/Area Number |
23790566
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| Research Category |
Grant-in-Aid for Young Scientists (B)
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| Allocation Type | Multi-year Fund |
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| Research Field |
Medical sociology
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| Research Institution | Kyoto University |
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Principal Investigator |
SUMI Eriko 京都大学, 医学(系)研究科(研究院), 助教 (30452337)
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| Project Period (FY) |
2011 – 2012
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| Keywords | 医療情報学 / 臨床試験 / データ収集 / 二次利用 / 電子カルテ |
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| Research Abstract |
I established the standard model of a data warehouse with a search system and data elements to retrieve from EMRs, which aims to predict the number of patients in a clinical trial. Then I established a method, i.e., how to translate the inclusion/exclusion criteria of a clinical trial into items in the items of the system, to search a patient in line with the inclusion/exclusion criteria of a clinical trial using EMRs search system. I evaluated the correlation between the estimated number of patients provided by the search system and the accrual achievement, and evaluated the completeness of mapping clinical manifestation in trial eligibility criteria into structured data elements in the EMRs. Moreover, As the second use of EMRs, I carried out a pharmacoepidemiology study and pilot-study of a use of EMR templates as case report forms to collect the data.
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[Journal Article] An eClinical Trial System for Cancer that Integrates with Clinical Pathways and Electronic Medical Records2012
Author(s)
Keiichi Yamamoto, Kenya Yamanaka, Etsuro Hatano, Eriko Sumi, Takamichi Ishii, Kojiro Taura, Kohta Iguchi, Satoshi Teramukai, Masayuki Yokode, Shinji Uemoto, Masanori Fukushima
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Journal Title
Clin Trials
Volume: 9(4)
Pages: 408-417
DOI
Peer Reviewed
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