비열등성 가설 설정 tip
(이미지 출처: US FDA Guidance(2016), Non-Inferiority Clinical Trials to Establish Effectiveness) 이미 유효성이 입증된 기존 기기(Active Control)의 효과와 새로운 기기(Test)의 효과를 비교하여, 새로운 기기의 효과가 기존 시험기기에 비해 열등하지 않음(비열등함) 을 평...
Tea Tasting Statisticians
New Guidelines for Statistical Reporting in the Journal
Title New Guidelines for Statistical Reporting in the Journal Information Link https://www.nejm.org/doi/full/10.1056/NEJMe1906559 Citation Harrington, D., D’...
Considerations Regarding Non-Interventional Studies for Drug and Biological Products Guidance for Industry (ENG)
Presentation date : 25.01.08 Hyeon-woo Jeong gave a presentation. This guideline outlines the requirements for utilizing Real World Evidence (RWE) to demonstrate drug effectiveness and safety. A N...
Considerations Regarding Non-Interventional Studies for Drug and Biological Products Guidance for Industry
Presentation date : 25.01.08 정현우님이 발표해주셨다. 이 가이드라인은 약물의 효과와 안전성을 입증하기 위해 Real World Evidence (RWE)를 활용할 때 따라야하는 가이드라인이다. Non-Interventional Study란 계획된 프로토콜에 따라 환자에게 처치를 하는 임상시험이 아니라 일상적인 의료관행에 맞춰서...
From Statistical Significance to Significant Others
🎊 Personal Milestone Update 🎊 I’m thrilled to announce my marriage to 👩💻SooYoung Kwak on Saturday, December 21st! ✨ Our Story: It all started when I came across SooYoung’s insightful article on ...
New Year Greeting
I hope everyone reading this message has a wonderful 2025 🎉 As we begin this year, I hope we all have a Uniformly Most Powerful career path ahead - one that helps us grow consistently and reach our...
Reflection Paper on Use of Real World Data in Non-Interventional Studies to Generate Real-World Evidence
Reflection Paper on Use of Real World Data in Non-Interventional Studies to Generate Real-World Evidence 곽수영님께서 발표해주셨다. 유럽 EMA의 가이드라인인데, ICH M14 가이드라인과 비교했을 때 내용상의 큰 차이는 없었다. 다만, 여기서는 real world e...
MHRA guideline on randomised controlled trials using real-world data to support regulatory decisions
발표자 : 이현빈 MHRA guideline on randomised controlled trials using real-world data to support regulatory decisions Real-World Data (RWD)라고 하면 많은 내용을 포함하고 있다. Randomized Controlled Trial에서 single arm으...
RWE guideline causal inference part2 (ENG)
On October 16th, we had the Pseudo Lab’s RWE guideline study. It was the final week covering causal inference concepts. Next week, we’ll cover the FDA framework guidelines. This week’s topics were ...
RWE guideline causal inference part1 (ENG)
We had our first meeting of the Pseudo Lab’s RWE (Real World Evidence) guideline study. To generate real world evidence from real world data, we need to understand the concept of causal inference. ...