臨床試驗 Clinical Trials
Date
Aug 20, 2020 12:00 AM — 3:49 PM
臨床試驗課程主要討論討二大主題: a) 臨床試驗設計與分析, 著重在統計相關議題. b) 基礎醫學與臨床醫學共通的實驗設計與分析, 著重在一般生物醫學的實驗設計與資料分析.
臨床試驗設計與分析
Introduction and Protocol
Ethics
Study Population and Outcome Measures
Study Controls
Basic Design
Randomization
Blinding
Sample Size
Safety Assessment
Quality of Life
Recruitment and Retaining of Participants
Data Safety Monitoring Committee
Interim Analysis
Data Analysis
- Baseline Assessment
- Analysis Set: ITT and PP
- Ineligibility
- Nonadherence
- Poor Quality Data
- Competing Events
- Missing Data
- Multiple Comparisons
- Adjustment of Covariates
- Subgroup Analysis
- Baseline Assessment
Reporting and Interpreting of Results
Equivalence and Noninferiority
Phase I Design
Phase II Design
Dose-Finding Design
Cancer Clinical Trial
Diagnostic Devices
Biomarker and Translation Medicine
Precision Medicine and Targeted Therapy
Vaccine Trial
Adaptive Design
Regulatory issues: ICH E9 and ICH E9 (R1)
醫學實驗設計與分析
- Basic Concepts in Experiments
- Experimental Unit and Replications
- Randomization
- Treatment Design and Experimental Design
- Crossed or Nested
- Complete or INcomplete
- Replications: True or Technical
- Data layout or Field
- Fixed Factors and Random Factors
- CRD (Completely Randomized Designs)
- One Way ANOVA
- Multiple Testings and Multiple Comparisons
- Fixed and Random Factors/Effects
- CRD
- Two Fixed Factors
- Balanced and Unbalanced
- Interaction
- ANCOVA (Analysis of Covariances)
- RCBD/CBD (Randomized Complete Block Designs)
- Block: Fixed or Random?
- RCBD Variations
- Replications
- Crossed Blocks
- LSD (Latin/Eular Square Design)
- GLSD (Graceo+Latin Square Design)
- SPD (Split Plot Design)
- CRD on the Whole Plots
- RCBD on the Whole Plots
- SSPD (Split Split Plot Design)
- SBD (Strip Plot Designs, Split Block Design)
- Crossover Design
- RMD (Repeated Measures Design)
- FD (Factorial Design)
- Incomplete Design
- BIBD (Balanced Incompete Block Design)
- FFD (Fractional Factorial Design)
