Archives

All posts by year.

2026

• Examples of Real-World Evidence Used in Medical Device Regulatory Decisions (Fiscal Years 2020–2025) (2026-04-19)
• FDA 가이던스 한국어 요약: Multiple Endpoints in Clinical Trials (2022) (2026-03-22)
• 식품의약품안전처(MFDS) 통계 관련 가이드라인 목록 (2026-03-15)
• FDA 통계(Biostatistics) 관련 가이던스 목록 (2026-03-15)
• 멍청해지기 전에 읽는 뇌과학 - 이인아 저 (독후감) (2026-03-01)
• Neuroscience to Read Before You Get Stupid (ENG) (2026-03-01)
• Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause (2026-03-01)
• Most important statistical ideas of the past 50 years_Gelman (2026-02-22)

2025

• 의료기기 임상 Project Template 개발 및 활용 (2025-11-22)
• Connection between noncomparative adaptive design and estimand framework (2025-11-15)
• Adjustment of Baseline Covariates in Randomized Controlled Trial (ENG) (2025-10-20)
• Adjustment of Baseline Covariates in Randomized Controlled Trial (2025-10-20)
• Session1_AI in Drug & Biological Product Development Hybrid Public Workshop 2025 (2025-10-09)
• Standard deviation and standard error (2025-10-03)
• 표준편차와 표준오차 (2025-10-03)
• 통계적 우월성 검정 가설 설정 (단측 검정 vs 양측 검정) (2025-09-28)
• Fisher와 Tea Tasting Lady (2025-08-10)
• 결혼과 이혼률, 그리고 생존분석 (2025-07-27)
• 식약처 임상통계 심사 평가시 일반적 고려사항 (2025-07-12)
• FDA Guidance Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests (2025-06-28)
• Weekly 1 on 1 Meeting (2025-06-07)
• 디지털 의료기기 임상 관련 정리 (2025-05-24)
• 데이터 사이언스 분야 영어 실력 늘리는 Tip (2025-04-13)
• 가짜연구소 발표 후기 (2025-03-29)
• 국제의료기기 병원설비전시회 KIMES 후기 (2025-03-23)
• Statistical humor (ENG) (2025-03-02)
• 의료기기의 실사용증거 적용에 대한 가이드라인 후기 (2025-02-23)
• 식약처 의료기기 임상관련 통계업무 (2025-02-23)
• Project Application; Adaptive Design and Master Protocol (2025-02-23)
• Adaptive design & Master protocol 스터디 모집 (영어로 진행) (2025-02-23)
• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (ENG) (2025-01-19)
• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (2025-01-19)
• 비열등성 가설 설정 tip (2025-01-18)
• New Guidelines for Statistical Reporting in the Journal (2025-01-12)
• Considerations Regarding Non-Interventional Studies for Drug and Biological Products Guidance for Industry (ENG) (2025-01-12)
• Considerations Regarding Non-Interventional Studies for Drug and Biological Products Guidance for Industry (2025-01-12)
• From Statistical Significance to Significant Others (2025-01-02)
• New Year Greeting (2025-01-02)

2024

• Reflection Paper on Use of Real World Data in Non-Interventional Studies to Generate Real-World Evidence (2024-12-11)
• MHRA guideline on randomised controlled trials using real-world data to support regulatory decisions (2024-12-11)
• RWE guideline causal inference part2 (ENG) (2024-12-11)
• RWE guideline causal inference part1 (ENG) (2024-12-11)
• Steps to avoid over use and misuse of ML in clinical research Review (2024-12-01)
• Comment on ICH M14 Guideline - part 2 (2024-11-17)
• Comment on ICH M14 Guideline - part 1 (2024-11-17)
• DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a RCT_Review (2024-11-17)
• Adjustment of baseline covariates (2024-11-17)
• Adaptive design (2024-11-17)
• Comment on Framework for FDA’s Real-World Evidence Program - part 2 (ENG) (2024-11-01)
• Comment on Framework for FDA’s Real-World Evidence Program - part 2 (2024-11-01)
• Comment on Framework for FDA’s Real-World Evidence Program - part 1 (ENG) (2024-11-01)
• Comment on Framework for FDA’s Real-World Evidence Program - part 1 (2024-11-01)
• 통계적 유의성 vs 임상적 유의성 (2024-11-01)
• Switching noninferiority and superiority trial (ENG) (2024-10-26)
• Framework for FDA’s Real-World Evidence Program part 1 (2024-10-26)
• Switching noninferiority and superiority trial (2024-10-19)
• Master protocol part 1 (2024-10-19)
• RWE guideline week2 causal inference part2 (2024-10-19)
• FDA Perspective on the Regulation of AI in Health Care and Biomedicine (2024-10-18)
• RWE guideline week1 causal inference (2024-10-09)
• Cluster Ranodmized Controlled Trial (2024-10-09)
• Sample size calculation in terms of epsilon and delta (2024-10-01)
• Speical ROC Curves (2024-09-28)
• Breast imaging understanding how accuracy is measured when lesions are the unit of analysis review (2024-09-28)
• Smart Causal Inference (2024-09-21)
• Biostat Guidance (2024-09-21)
• 국내 임상통계 관련 진로 소개 (2024-09-19)
• Pragmatic trial (2024-09-18)
• Introduction to advanced designs for clinical trial (2024-09-18)
• A Brief History of Free-Response ROC Paradigm Data Analysis 리뷰 (2024-09-18)