Tutorial on statistical considerations on subgroup analysis in confirmatory clinical trials

Methods for identification and confirmation of targeted subgroups in clinical trials: A systematic review

(2015) Thomas Ondra et al.   Journal of Biopharmaceutical Statistics

Statistical Considerations on Subgroup Analysis in Clinical Trials

(2015) Mohamed Alosh et al.   Statistics in Biopharmaceutical Research

Reliably Basing Conclusions on Subgroups of Randomized Clinical Trials

(2014) Armin Koch et al.   Journal of Biopharmaceutical Statistics

An Overview of Statistical Planning to Address Subgroups in Confirmatory Clinical Trials

(2014) Gary G. Koch et al.   Journal of Biopharmaceutical Statistics

Standardization for Subgroup Analysis in Randomized Controlled Trials

(2014) Ravi Varadhan et al.   Journal of Biopharmaceutical Statistics

Statistical Perspectives on Subgroup Analysis: Testing for Heterogeneity and Evaluating Error Rate for the Complementary Subgroup

(2014) Mohamed Alosh et al.   Journal of Biopharmaceutical Statistics

A Regulatory Perspective on Essential Considerations in Design and Analysis of Subgroups When Correctly Classified

(2014) Sue-Jane Wang et al.   Journal of Biopharmaceutical Statistics

Multiplicity and replicability: two sides of the same coin

(2014) Frank Bretz et al.   PHARMACEUTICAL STATISTICS

Methods for exploring treatment effect heterogeneity in subgroup analysis: an application to global clinical trials

(2014) I. Manjula Schou et al.   PHARMACEUTICAL STATISTICS

Multiplicity considerations for subgroup analysis subject to consistency constraint

(2013) Mohamed Alosh et al.   BIOMETRICAL JOURNAL

Graphical assessment of consistency in treatment effect among countries in multi-regional clinical trials

(2013) Joshua Chen et al.   Clinical Trials

Testing each hypothesis marginally at alpha while still controlling FWER: how and when

(2012) Jianjun David Li   STATISTICS IN MEDICINE

Bayesian models for subgroup analysis in clinical trials

(2011) Hayley E Jones et al.   Clinical Trials

Chain Procedures: A Class of Flexible Closed Testing Procedures With Clinical Trial Applications

(2011) Brian A. Millen et al.   Statistics in Biopharmaceutical Research

Regional differences in multinational clinical trials: anticipating chance variation

(2010) Ian C Marschner   Clinical Trials

Inconsistent trial assessments by the National Institute for Health and Clinical Excellence and IQWiG: standards for the performance and interpretation of subgroup analyses are needed

(2010) J. Hasford et al.   JOURNAL OF CLINICAL EPIDEMIOLOGY

No inconsistent trial assessments by NICE and IQWiG: different assessment goals may lead to different assessment results regarding subgroup analyses

(2010) Ralf Bender et al.   JOURNAL OF CLINICAL EPIDEMIOLOGY

Design and Analysis Considerations in Clinical Trials With a Sensitive Subpopulation

(2010) Yan D. Zhao et al.   Statistics in Biopharmaceutical Research

Adaptive patient enrichment designs in therapeutic trials

(2009) Sue-Jane Wang et al.   BIOMETRICAL JOURNAL

Optimizing Trial Design

(2009) Cyrus Mehta et al.   CIRCULATION

Lapatinib Combined With Letrozole Versus Letrozole and Placebo As First-Line Therapy for Postmenopausal Hormone Receptor–Positive Metastatic Breast Cancer

(2009) Stephen Johnston et al.   JOURNAL OF CLINICAL ONCOLOGY

A recycling framework for the construction of Bonferroni-based multiple tests

(2009) C.-F. Burman et al.   STATISTICS IN MEDICINE

Wild-TypeKRASIs Required for Panitumumab Efficacy in Patients With Metastatic Colorectal Cancer

(2008) Rafael G. Amado et al.   JOURNAL OF CLINICAL ONCOLOGY

A flexible strategy for testing subgroups and overall population

(2008) Mohamed Alosh et al.   STATISTICS IN MEDICINE

A graphical approach to sequentially rejective multiple test procedures

(2008) Frank Bretz et al.   STATISTICS IN MEDICINE

A flexible fixed-sequence testing method for hierarchically ordered correlated multiple endpoints in clinical trials

(2007) Mohammad F. Huque et al.   JOURNAL OF STATISTICAL PLANNING AND INFERENCE