KOR 43
- 의료기기 임상 Project Template 개발 및 활용
- Adjustment of Baseline Covariates in Randomized Controlled Trial
- Session1_AI in Drug & Biological Product Development Hybrid Public Workshop 2025
- 표준편차와 표준오차
- 통계적 우월성 검정 가설 설정 (단측 검정 vs 양측 검정)
- Fisher와 Tea Tasting Lady
- 결혼과 이혼률, 그리고 생존분석
- 식약처 임상통계 심사 평가시 일반적 고려사항
- FDA Guidance Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests
- 데이터 사이언스 분야 영어 실력 늘리는 Tip
- 가짜연구소 발표 후기
- 국제의료기기 병원설비전시회 KIMES 후기
- 의료기기의 실사용증거 적용에 대한 가이드라인 후기
- 식약처 의료기기 임상관련 통계업무
- Adaptive design & Master protocol 스터디 모집 (영어로 진행)
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
- 비열등성 가설 설정 tip
- Considerations Regarding Non-Interventional Studies for Drug and Biological Products Guidance for Industry
- Reflection Paper on Use of Real World Data in Non-Interventional Studies to Generate Real-World Evidence
- MHRA guideline on randomised controlled trials using real-world data to support regulatory decisions
- Comment on ICH M14 Guideline - part 2
- Comment on ICH M14 Guideline - part 1
- Adjustment of baseline covariates
- Adaptive design
- Comment on Framework for FDA's Real-World Evidence Program - part 2
- Comment on Framework for FDA's Real-World Evidence Program - part 1
- 통계적 유의성 vs 임상적 유의성
- Framework for FDA's Real-World Evidence Program part 1
- Switching noninferiority and superiority trial
- Master protocol part 1
- RWE guideline week2 causal inference part2
- FDA Perspective on the Regulation of AI in Health Care and Biomedicine
- RWE guideline week1 causal inference
- Cluster Ranodmized Controlled Trial
- Sample size calculation in terms of epsilon and delta
- Speical ROC Curves
- Breast imaging understanding how accuracy is measured when lesions are the unit of analysis review
- Smart Causal Inference
- Biostat Guidance
- 국내 임상통계 관련 진로 소개
- Pragmatic trial
- Introduction to advanced designs for clinical trial
- A Brief History of Free-Response ROC Paradigm Data Analysis 리뷰