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This page is for first-time readers who want practical regulatory statistics guidance quickly.

If you work in clinical/regulatory teams (non-statistician)

1. FDA Guidance Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests
2. Adjustment of Baseline Covariates in Randomized Controlled Trial
3. Connection between noncomparative adaptive design and estimand framework

If you prepare device submissions

1. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
2. 식약처 의료기기 임상관련 통계업무
3. 의료기기의 실사용증거 적용에 대한 가이드라인 후기

If you are new to trial design decisions

1. Introduction to advanced designs for clinical trial
2. Pragmatic trial
3. Switching noninferiority and superiority trial

Recommended weekly reading routine

• Read one guidance interpretation post from FDA Guidance Digest.
• Read one method post from Problem Index.
• Share one post with your clinical, RA/QA, or medical affairs team and discuss implications for your protocol.