Sue-Jane Wang

发表

The MicroArray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurements.

Hanlee P. Ji, G. M. Fischer, Stephen C. Harris, 2006, Nature biotechnology.

The MicroArray Quality Control (MAQC)-II study of common practices for the development and validation of microarray-based predictive models

Kevin C. Dorff, Aaron M. Smalter, Stephen C. Harris, 2010, Nature Biotechnology.

Regulatory Perspectives on Multiplicity in Adaptive Design Clinical Trials throughout a Drug Development Program

Sue-Jane Wang, Robert O'Neill, Sue-Jane Wang, 2011, Journal of biopharmaceutical statistics.

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

R. Varadhan, Sue-Jane Wang, 2016, Biometrical journal. Biometrische Zeitschrift.

Editorial: Making an Impact

Sue-Jane Wang, S. Julious, 2006 .

Modification of Sample Size in Group Sequential Clinical Trials

Sue-Jane Wang, H. M. Hung, Lu Cui, 1999, Biometrics.

Perspectives on the Use of Adaptive Designs in Clinical Trials. Part I. Statistical Considerations and Issues

Sue-Jane Wang, 2010, Journal of biopharmaceutical statistics.

Unblinded Adaptive Statistical Information Design Based on Clinical Endpoint or Biomarker

W. Brannath, Sue-Jane Wang, A. Koch, 2013 .

Adaptive enrichment with subpopulation selection at interim: methodologies, applications and design considerations.

Sue-Jane Wang, H. M. Hung, 2013, Contemporary clinical trials.

Evaluation of the extent of adaptation to sample size in clinical trials for cardiovascular and CNS diseases.

Sue-Jane Wang, Hua Peng, H. Hung, 2018, Contemporary clinical trials.

Perspective on adaptive designs: 4 years European Medicines Agency reflection paper, 1 year draft US FDA guidance - where are we now?

Sue-Jane Wang, M. Posch, A. Koch, 2012 .

Some Challenges With Statistical Inference in Adaptive Designs

Sue-Jane Wang, H. M. Hung, Peiling Yang, 2014, Journal of biopharmaceutical statistics.

Statistical challenges in a regulatory review of cardiovascular and CNS clinical trials

Sue-Jane Wang, H. M. Hung, Peiling Yang, 2016, Journal of biopharmaceutical statistics.

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

Sue-Jane Wang, R. O’Neill, H. M. Hung, 2007, Pharmaceutical statistics.

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

Sue-Jane Wang, Zheng Su, 2020, Contemporary Clinical Trials.

Evaluation of performance of some enrichment designs dealing with high placebo response in psychiatric clinical trials.

Yang Yang, H M James Hung, Sue-Jane Wang, 2011, Contemporary clinical trials.

Statistical Considerations for Testing Multiple Endpoints in Group Sequential or Adaptive Clinical Trials

H M James Hung, Sue-Jane Wang, Robert O'Neill, 2007, Journal of biopharmaceutical statistics.

Adaptive Covariate Adjustment in Clinical Trials

Sue-Jane Wang, H. James Hung, 2005, Journal of biopharmaceutical statistics.

Some Controversial Multiple Testing Problems in Regulatory Applications

Sue-Jane Wang, H. M. James Hung, Sue-Jane Wang, 2009, Journal of biopharmaceutical statistics.

Adaptive Statistical Inference Following Sample Size Modification Based on Interim Review of Effect Size *

Sue-Jane Wang, H. M. Hung, Lu Cui, 2002 .

Statistical considerations in evaluating pharmacogenomics-based clinical effect for confirmatory trials

Robert T O'Neill, Sue-Jane Wang, Sue-Jane Wang, 2010, Clinical trials.

Statistical Considerations for Noninferiority Trial Designs Without Placebo

Sue-Jane Wang, Sue-Jane Wang, H. James Hung, 2013 .

Multiple Testing of Noninferiority Hypotheses in Active Controlled Trials

Sue-Jane Wang, Sue-Jane Wang, H. James Hung, 2004, Journal of biopharmaceutical statistics.

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

Yi Tsong, Sue-Jane Wang, John Lawrence, 2002, Statistics in medicine.

Assessing treatment efficacy in noninferiority trials.

H M James Hung, Sue-Jane Wang, Sue-Jane Wang, 2003, Controlled clinical trials.

Statistical Issues On Objective, Design, And Analysis Of Noninferiority Active-controlled Clinical Trial

Yi Tsong, H M James Hung, Lu Cui, 2003, Journal of biopharmaceutical statistics.

TACT method for non‐inferiority testing in active controlled trials

H M James Hung, Sue-Jane Wang, Sue-Jane Wang, 2002, Statistics in medicine.

Utility and pitfalls of some statistical methods in active controlled clinical trials.

Yi Tsong, H M James Hung, Sue-Jane Wang, 2002, Controlled clinical trials.

Non-inferiority trials

Sue-Jane Wang, R. O’Neill, H. M. Hung, 2017 .

Non-Inferiority Trial

Sue-Jane Wang, R. O’Neill, H. M. Hung, 2007 .

On the Commonly Used Design and Statistical Considerations in Double Blind, Potentially Unblind, and Open‐Label Clinical Trials

Sue-Jane Wang, S. E. Nevius, Sue‐Jane Wang, 2004 .

An evidential approach to non‐inferiority clinical trials

Sue-Jane Wang, J. Blume, 2011, Pharmaceutical statistics.

Utility of adaptive strategy and adaptive design for biomarker-facilitated patient selection in pharmacogenomic or pharmacogenetic clinical development program.

Sue-Jane Wang, Sue-Jane Wang, 2008, Journal of the Formosan Medical Association = Taiwan yi zhi.

The Reproducibility of Lists of Differentially Expressed Genes in Microarray Studies

Weida Tong, Qian Xie, Huixiao Hong, 2007 .

Adaptive Designs in Drug Development

Sue-Jane Wang, H. M. Hung, 2014 .

The Bias Issue Under the Complete Null With Response Adaptive Randomization: Commentary on “Adaptive and Model-Based Dose-Ranging Trials: Quantitative Evaluation and Recommendation”

Sue-Jane Wang, Sue-Jane Wang, 2010 .

Ethnic Sensitive or Molecular Sensitive Beyond All Regions Being Equal in Multiregional Clinical Trials

Sue-Jane Wang, Sue-Jane Wang, H. James Hung, 2012, Journal of biopharmaceutical statistics.

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

J. Hsu, Sue-Jane Wang, F. Bretz, 2015, Statistics in medicine.

Gene expression Sample size for gene expression microarray experiments †

James J. Chen, Sue-Jane Wang, Chen-An Tsai, 2005 .

Recent advances in clinical trial design considerations in Thera"nostics".

Sue-Jane Wang, 2020, Contemporary clinical trials.

Designing pharmacogenomic studies to be fit for purpose.

Sue-Jane Wang, S. Patterson, D. Burns, 2010, Pharmacogenomics.

Panel forum on multiple comparison procedures: A commentary from a complex trial design and analysis plan

J. Hsu, Sue-Jane Wang, F. Bretz, 2013, Biometrical journal. Biometrische Zeitschrift.

FDG-PET lymphoma demonstration project invitational workshop.

W. Wilson, A. Barker, A. Zelenetz, 2007, Academic radiology.

Is pulmonary vascular resistance index predictive of exercise tolerance in adult patients with idiopathic pulmonary arterial hypertension.

Sue-Jane Wang, J. Hung, John Lawrence, 2012, Contemporary clinical trials.

Impacts of Predictive Genomic Classifier Performance on Subpopulation-Specific Treatment Effects Assessment

Sue-Jane Wang, Ming-Chung Li, 2016 .

Bayesian Sample Size Planning Tool for Phase I Dose-Finding Trials.

Sue-Jane Wang, Yuan Ji, Xiaolei Lin, 2022, JCO precision oncology.

Multi‐regional clinical trials – What are the challenges?

Sue-Jane Wang, 2010, Pharmaceutical statistics.

Comment on “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”

Sue-Jane Wang, H. M. Hung, 2010 .

Trial design issues and treatment effect modeling in multi‐regional schizophrenia trials

H M James Hung, Sue-Jane Wang, Yeh-Fong Chen, 2010, Pharmaceutical statistics.

A Regulatory Perspective on Choice of Margin and Statistical Inference Issue in Non‐inferiority Trials

Sue-Jane Wang, H M James Hung, Robert O'Neill, 2005, Biometrical journal. Biometrische Zeitschrift.

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

Sue-Jane Wang, Yuan Ji, Yunshan Duan, 2020, Contemporary clinical trials.

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

Yuan Ji, Sue-Jane Wang, Shengjie Yang, 2016, Contemporary clinical trials.

Multiple Comparison Procedures

A. Tamhane, Y. Hochberg, J. Hsu, 2009 .

Cutaneous Radiation Injuries: Models, Assessment and Treatments

Sue-Jane Wang, C. Rios, A. DiCarlo, 2020, Radiation Research.

Evaluation of external RNA controls for the assessment of microarray performance

Weida Tong, Huixiao Hong, Leming Shi, 2006, Nature Biotechnology.

Biomarker adaptive designs in clinical trials

Tzu-Pin Lu, Dung-Tsa Chen, Sue-Jane Wang, 2014 .

Application of Genomic Technologies for Bridging Strategy Involving Different Race and Ethnicity in Pharmacogenomics Clinical Trials

Sue-Jane Wang, 2012 .

Editorial

Sue-Jane Wang, S. Julious, 2006 .

Determinants of Utilization of Tay-Sachs Screening

Sue-Jane Wang, J. Rotter, L. Platt, 1993, Obstetrics and gynecology.

Modified toxicity probability interval design: a safer and more reliable method than the 3 + 3 design for practical phase I trials.

Yuan Ji, Sue-Jane Wang, Sue-Jane Wang, 2013, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

A Trans-Agency Workshop on the Pathophysiology of Radiation-Induced Lung Injury

Sue-Jane Wang, M. Satyamitra, Libero Marzella, 2021, Radiation Research.

The i3+3 design for phase I clinical trials

Sue-Jane Wang, Yuan Ji, Meizi Liu, 2020, Journal of biopharmaceutical statistics.

The i3+3 design for phase I clinical trials.

Sue-Jane Wang, Yuan Ji, Meizi Liu, 2019, Journal of Clinical Oncology.

Sample Size for Identifying Differentially Expressed Genes in Microarray Experiments

Sue-Jane Wang, James J. Chen, James J. Chen, 2004, J. Comput. Biol..

Multiple comparisons in complex clinical trial designs

Sue-Jane Wang, H M James Hung, Sue-Jane Wang, 2013, Biometrical journal. Biometrische Zeitschrift.

Adaptive patient enrichment designs in therapeutic trials

Sue-Jane Wang, Robert T O'Neill, H M James Hung, 2009, Biometrical journal. Biometrische Zeitschrift.

Group sequential test strategies for superiority and non‐inferiority hypotheses in active controlled clinical trials

Y Tsong, S J Wang, H M Hung, 2001, Statistics in medicine.

Challenges to multiple testing in clinical trials

Sue-Jane Wang, Sue-Jane Wang, H. James Hung, 2010, Biometrical journal. Biometrische Zeitschrift.

Methodological issues with adaptation of clinical trial design

Sue-Jane Wang, H M James Hung, Robert T O'Neill, 2006, Pharmaceutical statistics.

A Regulatory View on Adaptive/Flexible Clinical Trial Design

Robert T O'Neill, Sue-Jane Wang, H M James Hung, 2006, Biometrical journal. Biometrische Zeitschrift.

Paradigms for adaptive statistical information designs: practical experiences and strategies

Sue-Jane Wang, Robert O'Neill, H M James Hung, 2012, Statistics in medicine.

Editorial: Adaptive Designs: Appealing in Development of Therapeutics, and Where do Controversies Lie?

Sue-Jane Wang, Sue-Jane Wang, 2010, Journal of biopharmaceutical statistics.

Perspectives on the Use of Adaptive Designs in Clinical Trials. Part II. Panel Discussion

Frank Bretz, Tim Friede, Norbert Benda, 2010, Journal of biopharmaceutical statistics.

From Adaptive Design to Modern Protocol Design for Drug Development: Part II. Success Probabilities and Effect Estimates for Phase 3 Development Programs

Sue-Jane Wang, Frank Brefz, Sue-Jane Wang, 2010 .

From Adaptive Design to Modern Protocol Design for Drug Development: Part I. Editorial and Summary of Adaptive Designs Session at the Third FDA/DIA Statistics Forum

Frank Bretz, Sue-Jane Wang, Sue-Jane Wang, 2010 .

Commentary on “Personalized Medicine in Oncology: Hype or Hope?”

Sue-Jane Wang, 2009 .

Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant.

Sue-Jane Wang, I. Zineh, E. Unger, 2011, The Journal of clinical psychiatry.

Perspectives on statistical strategies for the regulatory biomarker qualification process

Sue-Jane Wang, S. Hendrix, L. McShane, 2021, Biomarkers in medicine.

A simple and efficient algorithm for genome-wide homozygosity analysis in disease

A. Singleton, J. Hardy, Sue-Jane Wang, 2009, Molecular systems biology.

Sample size for gene expression microarray experiments

Sue-Jane Wang, James J. Chen, Chen-An Tsai, 2005, Bioinform..

Guest Editors' introduction to the 15th anniversary special issue.

Sue-Jane Wang, Zheng Su, Yunzhi Lin, 2021, Contemporary clinical 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

Sue-Jane Wang, A. Fotenos, Libero Marzella, 2022, The Journal of Nuclear Medicine.

Short of complete abstinence: an analysis exploration of multiple drinking episodes in alcoholism treatment trials.

Robert T O'Neill, Sue-Jane Wang, Sue-Jane Wang, 2002, Alcoholism, clinical and experimental research.

Adapting the sample size planning of a phase III trial based on phase II data

H M James Hung, Robert T O'Neill, Sue-Jane Wang, 2006, Pharmaceutical statistics.

Impacts on type I error rate with inappropriate use of learn and confirm in confirmatory adaptive design trials

Sue-Jane Wang, H. M. James Hung, Robert T. O'Neill, 2010, Biometrical journal. Biometrische Zeitschrift.

A Commentary on the U.S. FDA Adaptive Design Draft Guidance and EMA Reflection Paper from a Regulatory Perspective and Regulatory Experiences

Sue-Jane Wang, Sue-Jane Wang, 2014 .

Adaptive design clinical trials and trial logistics models in CNS drug development

Robert O'Neill, Sue-Jane Wang, H. M. James Hung, 2011, European Neuropsychopharmacology.

Biomarker as a classifier in pharmacogenomics clinical trials: a tribute to 30th anniversary of PSI

Sue-Jane Wang, Sue-Jane Wang, 2007, Pharmaceutical statistics.

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

H M James Hung, Robert T O'Neill, Sue-Jane Wang, 2010, Pharmaceutical statistics.

Yi Tsong, Lu Cui, Sue-Jane Wang, 2002, Journal of biopharmaceutical statistics.

Commentary on “Applying CHW method to 2-in-1 design: gain or lose”

Lu Cui, H. M. James Hung, Sue Jane Wang, 2019, Journal of biopharmaceutical statistics.

Commentary on “Experiences in Model/Simulation for Early Phase or Late Phase Study Planning Aimed to Learn Key Design Elements”

Sue-Jane Wang, Sue-Jane Wang, 2009 .

Discussion of the “White Paper of the PhRMA Working Group on Adaptive Dose-Ranging Designs”

Sue-Jane Wang, Sue-Jane Wang, 2007, Journal of biopharmaceutical statistics.

Modeling and simulation for medical product development and evaluation: highlights from the FDA-C-Path-ISOP 2013 workshop

B. Corrigan, Sue-Jane Wang, T. Colatsky, 2014, Journal of Pharmacokinetics and Pharmacodynamics.

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

Sue-Jane Wang, Hai Zhu, Zhipeng Huang, 2022, Statistics in Biopharmaceutical Research.

Issues with Statistical Risks for Testing Methods in Noninferiority Trial Without a Placebo ARM

Sue-Jane Wang, H M James Hung, Robert O'Neill, 2007, Journal of biopharmaceutical statistics.

Family history: a comprehensive genetic risk assessment method for the chronic conditions of adulthood.

Sue-Jane Wang, J. Rotter, L. Raffel, 1997, American journal of medical genetics.

Indeterminate Data and Handling for Assessing Diagnostic Performance in Imaging Drug Developments

Sue-Jane Wang, 2023, The New England Journal of Statistics in Data Science.

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

Sue-Jane Wang, A. Fotenos, Shane C. Masters, 2022, Theranostics.

Some Recent Advances on Statistical Approaches for Planning Multi-regional Clinical Trials

Sue-Jane Wang, Xiangmin Zhang, H. M. James Hung, 2018 .

Some Recent Advances on Statistical Approaches for Planning Multi-regional Clinical Trials

Sue-Jane Wang, H. M. Hung, Xiangmin Zhang, 2017, Statistics in Biosciences.

Emerging Challenges of Clinical Trial Methodologies in Regulatory Applications

Sue-Jane Wang, Sue-Jane Wang, H. M. James Hung, 2014 .

Increased risk for type I (insulin-dependent) diabetes in relatives of patients with alopecia areata (AA).

Sue-Jane Wang, J. Rotter, T. Shohat, 1994, American journal of medical genetics.

The MicroArray Quality Control (MAQC)-II study of common practices for the development and validation of microarray-based predictive models

Todd H. Stokes, Kevin C. Dorff, Aaron M. Smalter, 2010, Nature Biotechnology.

Sample Size Adaptation in Fixed-Dose Combination Drug Trial

Sue-Jane Wang, Sue-Jane Wang, H M James Hung, 2012, Journal of biopharmaceutical statistics.

Flexible design clinical trial methodology in regulatory applications

Sue-Jane Wang, H M James Hung, Robert O'Neill, 2011, Statistics in medicine.

Adaptive Statistical Analysis Following Sample Size Modification Based on Interim Review of Effect Size

Sue-Jane Wang, H M James Hung, Lu Cui, 2005, Journal of biopharmaceutical statistics.

Rejoinder

Sue-Jane Wang, H. M. Hung, John Lawrence, 2006 .

The i3+3 design for phase I clinical trials

Sue-Jane Wang, Yuan Ji, Meizi Liu, 2019, Journal of biopharmaceutical statistics.

Bridging Study versus Prespecified Regions Nested in Global Trials

Sue-Jane Wang, Sue-Jane Wang, 2009 .

Regulatory Experience of Qualifying Total Kidney Volume as a Prognostic Biomarker for Clinical Trial Enrichment

Sue-Jane Wang, John Lawrence, H. J. James Hung, 2019, Statistics in Biopharmaceutical Research.

Non-inferiority trials

Sue-Jane Wang, H. M. Hung, R. O'neill, 2017 .

Pharmacogenomic data submissions to the FDA: clinical case studies.

Sue-Jane Wang, Grant A. Williams, W. Trepicchio, 2004, Pharmacogenomics.

Pharmacogenomic data submissions to the FDA: clinical pharmacology case studies.

Sue-Jane Wang, G. Ruaño, Shiew-Mei Huang, 2004, Pharmacogenomics.