<已截止>2024/1/27 (星期六)【新藥開發系列】Strategies for Acceleration Proof of Concept in Human 加速人體試驗概念驗證PoC之策略

I. Drug Development Roadmap (藥物開發路線圖)

II. Characteristics of the New Drug R & D (新藥研發的特點)

1. High risk and high cost (高風險及高成本)
2. Heavily regulatory process (嚴格的監管流程)
3. Market globalization (市場全球化)
4. Territoriality (屬地主義)
5. Economical pressure and challenge (經濟壓力與挑戰)

III. Aims of Clinical Development (臨床開發的目的)

IV. Causes of Failure in Clinical Trial (臨床試驗失敗的原因)

• Strategy and resolution (策略及解決方案)

V. Introduction to Clinical Trials (臨床試驗的介紹)

1. Phase I to Phase IV Clinical Trials (一至四期臨床試驗)
2. Decision making at End of Phase II (第二期臨床試驗結束時的決策)
3. First-in-human Trial (首次人體試驗)

VI. Exploratory INDs (探索性INDs)

• Microdose vs pharmacological approach (微劑量及藥理學方法之比較)

VII. Content and Purpose of Phase I/II Studies (I/II期臨床研究的內容與目的)

• Clinical Pharmacology (臨床藥理學)
  (1) Exploratory phase I vs confirmatory phase I (探索性及確認性第I期試驗之比較)
  (2) Role and Usage of Nonclinical Information (非臨床資訊的角色及用途)

VIII. Early PoC in Phase I/IIa (第I/IIa期的早期概念驗證)

1. First in Human Study (首次於人體執行之藥物臨床試驗)
   (1) Pharmacokinetic Study (藥物動力學試驗)
   A. Bioavailability studies (生體可用率試驗)
   B. ADME study (藥物代謝動力學試驗)
   a. Food effect (食物效應)
   b. Hepatic/renal impairment (肝/腎功能異常)
   c. Drug-drug interaction (藥物相互作用)
   d. PK/PD/safety relationship (藥動/藥效/安全性之關係)
   (2) Pharmacodynamic Study (藥效學試驗)
   A. Endpoint for clinical trial (臨床指標)
   B. Biomarkers (生物標記)
   – Surrogate endpoints, prognostic markers and predictive markers
2. Summary of Clinical Pharmacology Studies (臨床藥理學研究總結)

IX. Safety, Risk Assessment and Management (安全性、風險評估及管理)

1. Safety data collection (安全性資料的收集)
2. Objectives of safety data analysis (安全性資料分析的目的)
3. Responsibilities and goals (責任及目標)
4. Classic vs newer phase I trials (傳統與較新的I期試驗)
5. Safety monitoring and AE (安全性監測及不良事件)
6. Roles and responsibilities of investigator, study team member and sponsor (試驗主持人、試驗團隊及試驗委託者的角色和責任)
7. Adverse event reporting and documentation (不良事件的通報及記錄)
   – Adverse event term (不良事件的用詞)
8. Applications of MedDRA (MedDRA的應用)
9. AE term selection (不良事件的用詞選擇)
10. Severity vs seriousness (severity及seriousness的比較)
11. Causality (因果相關性)
12. Action taken and outcomes (採取的行動及結果)
13. Review and assessment of SAE (嚴重不良反應的審查及評估)
14. Clinical case evaluation (試驗案例的評估)
15. Site vs sponsor assessment (醫院端及試驗委託者的評估)
16. Narrative (敘述性資料)
17. Data Monitoring Committees (資料監測委員會)

X. Summary (總結)