治験促進のための治験実施体制についての治験責任医師・分担医師および治験依頼者への意識調査 : 責任医師等および依頼者へのアンケート結果に対する考察 Questionnaire to the Investigators and Monitors of the Sponsors of the Clinical Trials Enforcement System for Clinical Trials Promotion : Discussion on Results of the Study

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著者

    • 中村 忠博 NAKAMURA Tadahiro
    • 長崎大学医学部・歯学部附属病院治験管理センター Clinical Research and Trial Center, Nagasaki University Hospital
    • 一川 暢宏 ICHIKAWA Nobuhiro
    • 長崎大学医学部・歯学部附属病院治験管理センター Clinical Research and Trial Center, Nagasaki University Hospital
    • 佐々木 均 SASAKI Hitoshi
    • 長崎大学医学部・歯学部附属病院治験管理センター Clinical Research and Trial Center, Nagasaki University Hospital

抄録

The number of clinical trials in Japan is decreasing following the new GCP enforcement. For the promotion of clinical trials, establishment of a clinical trial enforcement system which meets the investigators and the sponsors' expectations, is necessary. We questioned the investigators and sponsors about problems in the clinical trial enforcement system and the function of the clinical research coordinator (CRC) in Nagasaki University Hospital. The results suggested that investigators and sponsors need assistance from CRC for a large portion of their clinical trial practices. It was noteworthy that when a sponsor applies for clinical trials to hospitals or clinics, the most important problem is the complexity of the document related to the clinical trial. The investigators and the sponsors need to be aware that a low number of participants prevents the progress of clinical trials. In addition, it was suggested that an economic incentive given to the investigators for clinical trial promotion is desirable

収録刊行物

  • 臨床薬理 = JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS  

    臨床薬理 = JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS 37(2), 75-82, 2006-03-31 

    The Japanese Society of Clinical Pharmacology and Therapeutics

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各種コード

  • NII論文ID(NAID)
    10018117685
  • NII書誌ID(NCID)
    AN0025404X
  • 本文言語コード
    JPN
  • 資料種別
    REV
  • ISSN
    03881601
  • データ提供元
    CJP書誌  J-STAGE 
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