[新聞] 浩鼎將變更設計 擴大三期臨床試驗
1.原文連結(必須檢附):
http://udn.com/news/story/6/1515374-%E6%B5%A9%E9%BC%8E%E5%B0%87%E8%AE%8A%E6%9B%B4%E8%A8%AD%E8%A8%88-%E6%93%B4%E5%A4%A7%E4%B8%89%E6%9C%9F%E8%87%A8%E5%BA%8A%E8%A9%A6%E9%A9%97
2.原文內容:2016-02-21 14:54 經濟日報 記者高行╱即時報導
針對浩鼎抗乳癌新藥OBI-822後續發展,董事長張念慈表示,此次解盲儘管未達標,但後
續仍將和台灣食衛署討論申請藥證的後續事宜,且有鑑於此次解盲相關數據已證明IgG、
IgM免疫抗體反應機制效應,現正朝第三期臨床試驗設計,主要在美、歐進行,將擴大全
球臨床試驗人數。
OBI-822多國臨床試驗計畫總主持人黃俊升指出,解盲初步結果顯示,OBI-822能讓產生免
疫反應的患者獲得非常顯著的益處,研究團隊相當振奮,將進一步以前期實驗結果為依據
,重新設計第三期臨床試驗,以有無產生免疫反應為主要標準,有效降低第三期臨床試驗
的風險。
黃俊升指出,如果按照目前第三期臨床設計規畫,以有無免疫反應作為新設計指標,若套
在這次解盲結果應該已「過關」,且法規單位對新指標的接受度也高,加上試驗結果的用
藥安全性不錯,對後續第三期臨床試驗的結果仍抱持樂觀。
3.心得/評論(必需填寫):國英數物理化學生物 六科不能上台大醫
取國英數 三科來上台大財金?
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※ 編輯: ncaa8702 (111.240.148.221), 02/21/2016 15:31:31
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