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臨床試驗

臨床試驗. 江斾萱 臨床試驗支援與規範經理 (Compliance Oversight Lead) 04 Oct 2013. 簡介 什麼是 臨床試驗 臨床試驗的過程 臨床試驗中的角色 臨床試驗與我們的關係. 外界對臨床試驗及臨床試驗專員的迷思. 英文要很好 ? 都要藥學系畢業 ? 臨床試驗專員賺很多 ? 臨床試驗報喜不報憂 ? 病人都是白老鼠 ?. 我對臨床試驗的了解程度. 簡介. 1997-2001 高雄醫學大學 生物醫學暨環境生物學系. 1997-2001 高雄醫學大學 生物醫學暨環境生物學系. 2001-2003

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臨床試驗

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  1. 臨床試驗 江斾萱 臨床試驗支援與規範經理 (Compliance Oversight Lead) 04 Oct 2013

  2. 簡介 • 什麼是臨床試驗 • 臨床試驗的過程 • 臨床試驗中的角色 • 臨床試驗與我們的關係

  3. 外界對臨床試驗及臨床試驗專員的迷思 • 英文要很好? • 都要藥學系畢業? • 臨床試驗專員賺很多? • 臨床試驗報喜不報憂? • 病人都是白老鼠?

  4. 我對臨床試驗的了解程度

  5. 簡介 1997-2001 高雄醫學大學 生物醫學暨環境生物學系

  6. 1997-2001 高雄醫學大學 生物醫學暨環境生物學系

  7. 2001-2003 國立成功大學醫學院 分子醫學研究所

  8. 2003-2006 國立陽明大學醫學院 生物藥學研究所

  9. Pfizer Ltd 2006-2009 臨床試驗專員 2009-2010 資深臨床試驗專員 2010-2012 臨床試驗副理 2012-2013 臨床試驗支援與規範副理 2013- 臨床試驗支援與規範經理

  10. 美國藥品研究與制造商協會（PhRMA）

  11. The Drug Development Process NDA / MAA Clinical Data Analysis Full Development Registration Candidate Medicine Tested in 1000-5,000 Patients (Phase III) Studies in 100-300 Patients (Phase II) Extensive Safety Studies Large Amounts of Candidate Medicine Synthesized Studies in Healthy Volunteers (Phase I) Candidate Formulations Developed Exploratory Development Early Safety Studies Synthesis of Compounds Screening Project Team and Plans Discovery

  12. Study team members: Sponsor Clinical Trial Associate Project Manager Clinical Research Associate (CRA) Clinician Data Manager Study Manager

  13. 試驗計劃書

  14. Clinician Development Statistician • Survey from the database: which country to choose? • Recommend by stakeholders • Talk to each of the country for the feasibility

  15. 30 20 10 50 50 20 20 50 50 30

  16. Clinician Development Statistician Data manager Study manager Central Lab Supply Chain Quality Assurance Clinical Operation Team

  17. 50 ? ? ? ? ? ? ? ? ? ? ? ? ?

  18. Clinical Study Protocol • Summary • Introduction • Trial objectives • Trial design • Subject selection • Trial treatments • Trial procedures • Assessments • Adverse event reporting • Data analysis/ statistical methods • Quality control and quality assurance • Data handling and record keeping • Ethics • Definition of end of trial • Publication of trial results • References

  19. 仿單

  20. 臨床試驗 • CRA的工作形態 • Application 送件 • Documentation 做過的就要留下痕跡 • Monitoring 監測 • Communication 溝通 • CRA的性格 • 動：開朗性格/溝通協調/高抗壓性 • 靜：細心/善於整理資料/仔細 • 多工：一心多用 • 藥廠與臨床試驗機構 (CRO, Contract Research Organization)

  21. Email: hsing001@gmail.com / Deborah.Chiang@pfizer.com Mobile: 0952 187173 連絡方式

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