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Modified Toxicity Probability Interval Design: A Safer and More Reliable Method Than the 3 + 3 Design for Practical Phase I Trials

Journal of clinical oncology, 2013-05, Vol.31 (14), p.1785-1791

2013

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A targeted simulation‐extrapolation method for evaluating biomarkers based on new technologies in precision medicine

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2022-05, Vol.21 (3), p.584-598

2022

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Adaptive patient enrichment designs in therapeutic trials

Biometrical journal, 2009-04, Vol.51 (2), p.358-374

2009

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Treatment effect heterogeneity for univariate subgroups in clinical trials: Shrinkage, standardization, or else

Biometrical journal, 2016-01, Vol.58 (1), p.133-153

2016

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Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2007-07, Vol.6 (3), p.227-244

2007

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The i3+3 design for phase I clinical trials

Journal of biopharmaceutical statistics, 2020-03, Vol.30 (2), p.294-304

2020

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The impact of misclassification errors on the performance of biomarkers based on next-generation sequencing, a simulation study

Journal of biopharmaceutical statistics, 2024-09, Vol.34 (5), p.700-718

2024

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Paradigms for adaptive statistical information designs: practical experiences and strategies

Statistics in medicine, 2012-11, Vol.31 (25), p.3011-3023

2012

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A Bayesian interval dose-finding design addressingOckham's razor: mTPI-2

Contemporary clinical trials, 2017-07, Vol.58, p.23-33

2017

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Recent advances in clinical trial design considerations in Thera“nostics”

Contemporary clinical trials, 2020-09, Vol.96, p.106100-106100, Article 106100

Wang, Sue-Jane

2020

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Comments on 'Twenty-five years of confirmatory adaptive designs: opportunities and pitfalls'

Statistics in medicine, 2016-02, Vol.35 (3), p.348-349

2016

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Multiplicity in confirmatory clinical trials: a case study with discussion from a JSM panel

Statistics in medicine, 2015-11, Vol.34 (26), p.3461-3480

2015

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Modification of Sample Size in Group Sequential Clinical Trials

Biometrics, 1999-09, Vol.55 (3), p.853-857

1999

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Consideration of regional difference in design and analysis of multi-regional trials

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2010-07, Vol.9 (3), p.173-178

2010

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Prostate Cancer Theranostics: Concurrent Approvals by the Food and Drug Administration of the First Diagnostic Imaging Drug Indicated to Select Patients for a Paired Radioligand Therapeutic Drug

Journal of Nuclear Medicine, 2022-11, Vol.63 (11), p.1642-1643

2022

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Hi3 + 3: A model-assisted dose-finding design borrowing historical data

Contemporary clinical trials, 2021-10, Vol.109, p.106437-106437, Article 106437

2021

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Flexible design clinical trial methodology in regulatory applications

Statistics in medicine, 2011-06, Vol.30 (13), p.1519-1527

2011

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

Journal of biopharmaceutical statistics, 2014-01, Vol.24 (1), p.19-41

2014

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Performance of LTMLE in the Presence of Missing Data in Control-Matched Longitudinal Studies

Statistics in biopharmaceutical research, 2023-07, Vol.15 (3), p.618-637

2023

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Challenges to multiple testing in clinical trials

Biometrical journal, 2010-12, Vol.52 (6), p.747-756

2010

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Guest editors-in-chief note to COVID-19 special issue

Contemporary clinical trials, 2021-02, Vol.101, p.106241-106241, Article 106241

2021

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Some fundamental issues with non-inferiority testing in active controlled trials

Statistics in medicine, 2003-01, Vol.22 (2), p.213-225

2003

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Some Controversial Multiple Testing Problems in Regulatory Applications

Journal of biopharmaceutical statistics, 2009-01, Vol.19 (1), p.1-11

2009

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Theranostics approach in drug development: is there study efficiency when the prevalence of the molecular target is very high?

Theranostics, 2022, Vol.12 (7), p.3079-3083

2022

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Evaluation of external RNA controls for the assessment of microarray performance

Nature biotechnology, 2006-09, Vol.24 (9), p.1132-1139

2006

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Modified Toxicity Probability Interval Design: A Safer and More Reliable Method Than the 3 + 3 Design for Practical Phase I Trials

A targeted simulation‐extrapolation method for evaluating biomarkers based on new technologies in precision medicine

Adaptive patient enrichment designs in therapeutic trials

Treatment effect heterogeneity for univariate subgroups in clinical trials: Shrinkage, standardization, or else

Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset

The i3+3 design for phase I clinical trials

The impact of misclassification errors on the performance of biomarkers based on next-generation sequencing, a simulation study

Paradigms for adaptive statistical information designs: practical experiences and strategies

A Bayesian interval dose-finding design addressingOckham's razor: mTPI-2

Recent advances in clinical trial design considerations in Thera“nostics”

Comments on 'Twenty-five years of confirmatory adaptive designs: opportunities and pitfalls'

Multiplicity in confirmatory clinical trials: a case study with discussion from a JSM panel

Modification of Sample Size in Group Sequential Clinical Trials

Consideration of regional difference in design and analysis of multi-regional trials

Prostate Cancer Theranostics: Concurrent Approvals by the Food and Drug Administration of the First Diagnostic Imaging Drug Indicated to Select Patients for a Paired Radioligand Therapeutic Drug

Hi3 + 3: A model-assisted dose-finding design borrowing historical data

Flexible design clinical trial methodology in regulatory applications

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

Performance of LTMLE in the Presence of Missing Data in Control-Matched Longitudinal Studies

Challenges to multiple testing in clinical trials

Guest editors-in-chief note to COVID-19 special issue

Some fundamental issues with non-inferiority testing in active controlled trials

Some Controversial Multiple Testing Problems in Regulatory Applications

Theranostics approach in drug development: is there study efficiency when the prevalence of the molecular target is very high?

Evaluation of external RNA controls for the assessment of microarray performance

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