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―

• 中村 忠博

  長崎大学医学部・歯学部附属病院治験管理センター

• 一川 暢宏

  長崎大学医学部・歯学部附属病院治験管理センター

• 佐々木 均

  長崎大学医学部・歯学部附属病院治験管理センター

書誌事項

タイトル別名

• 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
• Discussion on Results of the Study
• 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

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

  臨床薬理 37 (2), 75-82, 2006

  一般社団法人 日本臨床薬理学会

キーワード

• clinical trial enforcement system
• clinical research coordinator
• promotion
• questionnaires

詳細情報

• CRID: 1390282680344848000
• NII論文ID: 10018117685
• NII書誌ID: AN0025404X
• DOI: 10.3999/jscpt.37.2_75
• ISSN: 18828272
• ISSN: 03881601
• Web Site: https://search.jamas.or.jp/link/ui/2006235866
• 本文言語コード: ja
• データソース種別:
  • JaLC
  • Crossref
  • CiNii Articles
• 抄録ライセンスフラグ: 使用不可