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<b>Roles of the Data Storage System in Clinical Trials and Observational Cohort Studies </b>
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- UEDA Shinichiro
- Department of Clinical Pharmacology & Therapeutics, University of the Ryukyus
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- KAGEYAMA Shigeru
- Division of Clinical Pharmacology and Therapeutics, Jikei University School of Medicine
Bibliographic Information
- Other Title
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- <b>3.臨床試験,観察研究におけるデータストレージシステムの活用 </b>
- Roles of the Data Storage System in Clinical Trials and Observational Cohort Studies
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Description
Appropriate observational studies with sufficient external validity are apparently warranted to assess comparative effectiveness and safety of treatment with approved drugs in real world clinical practice. This kind of study must register patients consecutively without any arbitrariness, assess outcome carefully, (e.g. cardiovascular events) and automatically extract clinical data including results from laboratory tests and prescribed drugs. Clinical trials for the assessment of efficacy of newly developing drugs may also need such patients' registry. Data storage system by SS-MIX may be appropriate for this purpose. (Jpn J Pharmacoepidemiol 2013;18(1):31-34)
Journal
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- Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku
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Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku 18 (1), 31-34, 2013
Japanese Society for Pharmacoepidemiology
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Keywords
Details 詳細情報について
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- CRID
- 1390282679459604352
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- NII Article ID
- 130004541714
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- ISSN
- 1882790X
- 13420445
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- Text Lang
- ja
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- Data Source
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- JaLC
- Crossref
- CiNii Articles
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- Abstract License Flag
- Disallowed