Categories

This site uses six audience-facing categories. Language is handled separately with tags (lang-kor, lang-eng).

Clinical Trial Design

Methodology for protocol planning, hypothesis strategy, estimands, adaptive designs, and covariate adjustment.

• Adjustment of Baseline Covariates in Randomized Controlled Trial
• Connection between noncomparative adaptive design and estimand framework
• Switching noninferiority and superiority trial

Regulatory Science

FDA/MFDS/ICH-focused interpretation posts, with practical implications for submissions.

• FDA Guidance Digest
• Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause
• 식약처 의료기기 임상관련 통계업무

Real World Evidence

RWE strategy, causal inference, and non-interventional evidence design.

• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
• Considerations Regarding Non-Interventional Studies for Drug and Biological Products Guidance for Industry
• RWE guideline week1 causal inference

Medical AI

AI/ML in clinical research, diagnostic performance metrics, and model evaluation context.

• FDA Guidance Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests
• FDA Perspective on the Regulation of AI in Health Care and Biomedicine
• Speical ROC Curves

Statistics Fundamentals

Core concepts and explainers for broader technical literacy.

• Standard deviation and standard error
• 표준편차와 표준오차
• 통계적 우월성 검정 가설 설정 (단측 검정 vs 양측 검정)

Notes & Reads

Book notes, career reflections, and personal/professional commentary.

• Neuroscience to Read Before You Get Stupid
• 국내 임상통계 관련 진로 소개
• Fisher와 Tea Tasting Lady