Detecting and accounting for violations of the constancy assumption in non-inferiority clinical trials

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

(2015) Qing Liu et al.   Journal of Biopharmaceutical Statistics

Semiparametric Bayesian commensurate survival model for post-market medical device surveillance with non-exchangeable historical data

(2013) Thomas A. Murray et al.   BIOMETRICS

Adaptive adjustment of the randomization ratio using historical control data

(2013) Brian P Hobbs et al.   Clinical Trials

Nevirapine versus efavirenz for patients co-infected with HIV and tuberculosis: a randomised non-inferiority trial

(2013) Maryline Bonnet et al.   LANCET INFECTIOUS DISEASES

Adjusting for Unknown Bias in Noninferiority Clinical Trials

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

Hierarchical Commensurate and Power Prior Models for Adaptive Incorporation of Historical Information in Clinical Trials

(2011) Brian P. Hobbs et al.   BIOMETRICS

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

(2011) Thomas R Fleming et al.   Clinical Trials

Raltegravir once daily or twice daily in previously untreated patients with HIV-1: a randomised, active-controlled, phase 3 non-inferiority trial

(2011) Joseph J Eron et al.   LANCET INFECTIOUS DISEASES

Bio-creep in non-inferiority clinical trials

(2010) Siobhan Everson-Stewart et al.   STATISTICS IN MEDICINE

Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial

(2009) Jeffrey L Lennox et al.   LANCET

Class-Sparing Regimens for Initial Treatment of HIV-1 Infection

(2008) Sharon A. Riddler et al.   NEW ENGLAND JOURNAL OF MEDICINE

Determining the Effective Sample Size of a Parametric Prior

(2007) Satoshi Morita et al.   BIOMETRICS

Current issues in non-inferiority trials

(2007) Thomas R. Fleming   STATISTICS IN MEDICINE