🎊 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 ...

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 곽수영님께서 발표해주셨다. 유럽 EMA의 가이드라인인데, ICH M14 가이드라인과 비교했을 때 내용상의 큰 차이는 없었다. 다만, 여기서는 real world e...

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...

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 ...

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. ...

Information link: https://www.nature.com/articles/s41591-022-01961-6 Introduction The lackluster performance of  many machine learning (ML) systems in healthcare has been well   docu...

김청수님이 발표해주셨다. Protocol development에서 특히 개념적 정의를 operational definition으로 옮기는 내용을 중점적으로 살펴보았다. 먼저 개념적 정의는 연구에서 우리가 측정하고자 하는 개념이다. 예시 : 질환을 정의하기 위한 임상적 진단 기준이나 관심 노출을 정의하기 위한 약물 복용의 측정이다. 그런데 개념적 정의는...

가짜연구소 스터디에서 ICH M14 guideline에 대해 다루었다. ICH(The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) 가이드라인은 규제기관과 제약 회사 등 관련 업계에서 인정받는 과학적이고 기술적인 가이드...

Information link: https://www.bmj.com/content/363/bmj.k3750 Introduction RCT(randomised controlled trials) Properly conducted, randomised controlled trials are considered to be the b...