FDA Guidance
E9 Statistical Principles for Clinical Trials
Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
Multiple Endpoints in Clinical Trials
Adaptive Designs for Medical Device Clinical Studies
Adaptive Designs for Clinical Trials of Drugs and Biologics
Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act
EMEA Guidance
Statistical Principles for Clinical Trials
Estimands and sensitivity analysis in clinical trials
Guideline for good clinical practice
Point to consider on multiplicity issues in clinical trials
Methodological issues in confirmatory clinical trials planned with an adaptive design