Biostat Guidance

가짜연구소에서 임상시험 통계 가이드라인을 공부하고 자료를 정리하였습니다.

7기 Let Biostat Guidance Guide Us 팀에서 제작하였습니다.

자료 링크 https://pseudo-lab.github.io/Let-Biostat-Guidance-Guide-Us/intro.html

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