가짜연구소에서 임상시험 가이드라인을 공부하는 모임입니다. 주로 통계 분야에 집중하여 공부하였습니다.
자료 링크 https://pseudo-lab.github.io/Let-Biostat-Guidance-Guide-Us/intro.html
도움이 되었다면 깃허브 스타를 눌러주세요!
정리한 자료
Good Clinical Practice
Guideline for Industry E9 Statistical Principles for Clinical Trials
Points to Consider on Switching between Superiority and Non-inferiority
DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomized controlled trial
Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Guidance for Industry and FDA Staff
E9(R1) STATISTICAL PRINCIPLES FOR CLINICAL TRIALS: ADDENDUM: ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS