查詢結果分析
來源資料
頁籤選單縮合
題名 | 臨床試驗查核與統計方面缺失=Inspection of Clinical Trials and Statistical Deficiencies |
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作者姓名(中文) | 劉仁沛; | 書刊名 | 臨床試驗中英文季刊 |
卷期 | 4 2007.11[民96.11] |
頁次 | 頁12-25 |
分類號 | 412.24 |
關鍵詞 | 查核; 藥品優良臨床試驗規範; 統計缺失; Inspection; Good clinical practice; Statistical deficiencies; |
語文 | 中文(Chinese) |
中文摘要 | 為了確保臨床試驗受試者的福祉及臨床試驗能按「藥品優良臨床試驗規範」(Good Clinical Practice, GCP)確實執行,我國於1997年7月1號起,開始對臺灣查驗登記用之臨床試驗進行查核,迄今已滿十年,本文將對臺灣臨床試驗查核的緣起進行簡述,並將十年來所發現有關統計部分的缺失作一概述,最後對臺灣臨床試驗查核的未來展望與方向提出具體的建議。 |
英文摘要 | To protect the welfare of the trial subjects and to ensure that the clinical trials are conducted according to the Good Clinical Practice, Since July 1, 1997, Taiwan government started to perform inspection for clinical trials conducted in Taiwan for the purpose of registration. Therefore this year marks the anniversary of trial inspection in Taiwan. This article describes a brief history for implementation of inspection of registration trial in Taiwan. In addition, we elucidate some statistical deficiencies encountered during the past 10 years. Final remarks on the suggestions for future directions and fundamental changes of inspection for registration trials are also provided. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。