On Robustness of Noninferiority Clinical Trial Designs Against Bias, Variability, and Nonconstancy

On the Lower Predictive Bound Approach for Noninferiority Clinical Trials with Binary Data

(2014) Qing Liu et al.   Journal of Biopharmaceutical Statistics

Adjusting for Unknown Bias in Noninferiority Clinical Trials

(2013) Katherine Odem-Davis et al.   Statistics in Biopharmaceutical Research

Statistical considerations in biosimilar clinical efficacy trials with asymmetrical margins

(2012) Yulan Li et al.   STATISTICS IN MEDICINE

Some essential considerations in the design and conduct of non-inferiority trials

(2011) Thomas R Fleming et al.   Clinical Trials

Evaluating Rivaroxaban for Nonvalvular Atrial Fibrillation — Regulatory Considerations

(2011) Thomas R. Fleming et al.   NEW ENGLAND JOURNAL OF MEDICINE

Inferiority Index and Margin in Noninferiority Trials

(2011) Gang Li et al.   Statistics in Biopharmaceutical Research

Understanding the FDA Guidance on Adaptive Designs: Historical, Legal, and Statistical Perspectives

(2010) Qing Liu et al.   Journal of Biopharmaceutical Statistics

Blinded Independent Central Review of the Progression-Free Survival Endpoint

(2010) O. Amit et al.   ONCOLOGIST