Let Biostat Guidance Guide Us (LBGGU)

Let Biostat Guidance Guide Us (LBGGU)#

가짜연구소에서 임상시험 가이드라인을 공부하는 모임입니다. 주로 통계 분야에 집중하여 공부하였습니다.

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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