<b>Roles of the Data Storage System in Clinical Trials and Observational Cohort Studies </b>

  • UEDA Shinichiro
    Department of Clinical Pharmacology & Therapeutics, University of the Ryukyus
  • KAGEYAMA Shigeru
    Division of Clinical Pharmacology and Therapeutics, Jikei University School of Medicine

Bibliographic Information

Other Title
  • <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

Details 詳細情報について

  • CRID
    1390282679459604352
  • NII Article ID
    130004541714
  • DOI
    10.3820/jjpe.18.31
  • ISSN
    1882790X
    13420445
  • Text Lang
    ja
  • Data Source
    • JaLC
    • Crossref
    • CiNii Articles
  • Abstract License Flag
    Disallowed

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