Archives
- 19 Jan Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (ENG)
- 19 Jan Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
- 18 Jan 비열등성 가설 설정 tip
- 12 Jan New Guidelines for Statistical Reporting in the Journal
- 12 Jan Considerations Regarding Non-Interventional Studies for Drug and Biological Products Guidance for Industry (ENG)
- 12 Jan Considerations Regarding Non-Interventional Studies for Drug and Biological Products Guidance for Industry
- 02 Jan From Statistical Significance to Significant Others
- 02 Jan New Year Greeting
- 11 Dec Reflection Paper on Use of Real World Data in Non-Interventional Studies to Generate Real-World Evidence
- 11 Dec MHRA guideline on randomised controlled trials using real-world data to support regulatory decisions
- 11 Dec RWE guideline causal inference part2 (ENG)
- 11 Dec RWE guideline causal inference part1 (ENG)
- 01 Dec Steps to avoid over use and misuse of ML in clinical research Review
- 17 Nov Comment on ICH M14 Guideline - part 2
- 17 Nov Comment on ICH M14 Guideline - part 1
- 17 Nov DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a RCT_Review
- 17 Nov Adjustment of baseline covariates
- 17 Nov Adaptive design
- 01 Nov Comment on Framework for FDA's Real-World Evidence Program - part 2 (ENG)
- 01 Nov Comment on Framework for FDA's Real-World Evidence Program - part 2
- 01 Nov Comment on Framework for FDA's Real-World Evidence Program - part 1 (ENG)
- 01 Nov Comment on Framework for FDA's Real-World Evidence Program - part 1
- 01 Nov 통계적 유의성 vs 임상적 유의성
- 26 Oct Switching noninferiority and superiority trial (ENG)
- 26 Oct Framework for FDA's Real-World Evidence Program part 1
- 19 Oct Switching noninferiority and superiority trial
- 19 Oct Master protocol part 1
- 19 Oct RWE guideline week2 causal inference part2
- 18 Oct FDA Perspective on the Regulation of AI in Health Care and Biomedicine
- 09 Oct RWE guideline week1 causal inference
- 09 Oct Cluster Ranodmized Controlled Trial
- 01 Oct Sample size calculation in terms of epsilon and delta
- 28 Sep Speical ROC Curves
- 28 Sep Breast imaging understanding how accuracy is measured when lesions are the unit of analysis review
- 21 Sep Smart Causal Inference
- 21 Sep Biostat Guidance
- 19 Sep 국내 임상통계 관련 진로 소개
- 18 Sep Pragmatic trial
- 18 Sep Introduction to advanced designs for clinical trial
- 18 Sep A Brief History of Free-Response ROC Paradigm Data Analysis 리뷰