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BTBA presents: 生技來一刻

BTBA presents: 生技來一刻

Technology

藥物醫材於真實世界中的安全性監測 -- 藥物流行病學家Dr. Darren Toh杜勝偉教授

藥物醫材於真實世界中的安全性監測 -- 藥物流行病學家Dr. Darren Toh杜勝偉教授

2022-04-01
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監測已批准的藥物以及醫療器材在現實世界中使用的安全性狀況,尤其是任何不良反應的追蹤,是FDA重要的任務之一。然而在2007年前,FDA往往是被動地等待企業、醫院以及消費者向FDA提供反饋,再由機構評估採取措施的必要性。FDA Sentinel System的建立試圖集結各大數據中心、學界以及業界的力量,創造高達一億人的醫療電子數據,讓FDA可以主動與即時地監測藥物被使用的狀況。

這集我們邀請到Sentinel System的首席科學家、哈佛大學流行病學教授Dr. Darren Toh 杜勝偉博士,分享藥物流行病學家眼中的真實世界證據的取得以及應用,以及他協助建立Sentinel System的心路歷程。也分享COVID-19疫情期間,大量流行病學研究被發表又如何改變大家對於真實世界資料的使用想像。

  • 藥物流行病學研究內容 02:52
  • 真實世界的資料來源 07:48
  • 近年真實世界證據被重視的原因與契機 17:00
  • Sentinel System的簡介以及歷程 24:10
  • 現在真實世界數據使用的痛點與機會 32:20
  • 講者職涯規劃 43:30
  • 不同領域的人如何加速真實世界證據地的應用 48:10
  • 講者未來五年規劃 54:28
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