Statistical Issues and Controversies in Active-Controlled, “Noninferiority” Trials

Indirect comparisons in the comparative efficacy and non-inferiority settings

(2011) Steven Snapinn et al.   PHARMACEUTICAL STATISTICS

Active controlled studies in antibiotic drug development

(2011) Aaron Dane   PHARMACEUTICAL STATISTICS

Through the looking glass: understanding non-inferiority

(2011) Jennifer Schumi et al.   Trials

PISC Expert Team White Paper: Toward a Consistent Standard of Evidence When Evaluating the Efficacy of an Experimental Treatment From a Randomized, Active-Controlled Trial

(2010) Patrick Peterson et al.   Statistics in Biopharmaceutical Research

Issues in Noninferiority Trials: The Evidence in Community‐Acquired Pneumonia

(2008) Thomas R. Fleming et al.   CLINICAL INFECTIOUS DISEASES

Current issues in non-inferiority trials

(2007) Thomas R. Fleming   STATISTICS IN MEDICINE

Preservation of effect and the regulatory approval of new treatments on the basis of non-inferiority trials

(2007) Steven Snapinn et al.   STATISTICS IN MEDICINE