Works by Wang, Sue Jane

Results: 82

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

Published in:

Statistics in Biopharmaceutical Research, 2023, v. 15, n. 3, p. 618, doi. 10.1080/19466315.2022.2108136

By:

Wang, Sue-Jane;
Huang, Zhipeng;
Zhu, Hai

Publication type:

Article

Comment on "Estimands for Recurrent Event Endpoints in the Presence of a Terminal Event".

Published in:

Statistics in Biopharmaceutical Research, 2023, v. 15, n. 2, p. 249, doi. 10.1080/19466315.2022.2029556

By:

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

Publication type:

Article

Statement on P-values.

Published in:

2021

By:

Gwise, Thomas;
Rothmann, Mark D.;
James Hung, H.M.;
Amatya, Anup;
Rothwell, Rebecca;
Wang, Sue Jane;
Wu, Yute;
Smith, Fraser;
Weng, Yu-Ting;
Andraca-Carrera, Eugenio;
Grosser, Stella;
Chattopadhyay, Somesh;
Collins, Sylva H.

Publication type:

Letter

p-Value, Hypothesis Testing, Strength of Evidence: Comment on "The Role of p-Values in Judging the Strength of Evidence and Realistic Replication Expectations".

Published in:

Statistics in Biopharmaceutical Research, 2021, v. 13, n. 1, p. 30, doi. 10.1080/19466315.2020.1811150

By:

Hung, H. M. James;
Lawrence, John;
Wang, Sue-Jane

Publication type:

Article

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

Published in:

Statistics in Biopharmaceutical Research, 2019, v. 11, n. 3, p. 239, doi. 10.1080/19466315.2019.1584913

By:

Lawrence, John;
Wang, Sue-Jane;
James Hung, H. M.

Publication type:

Article

Genomic Classifier for Patient Enrichment: Misclassification and Type I Error Issues in Pharmacogenomics Noninferiority Trial.

Published in:

Statistics in Biopharmaceutical Research, 2011, v. 3, n. 2, p. 310, doi. 10.1198/sbr.2010.10012

By:

Wang, Sue-Jane

Publication type:

Article

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

Published in:

Statistics in Biopharmaceutical Research, 2010, v. 2, n. 4, p. 458, doi. 10.1198/sbr.2010.09054COMM2

By:

Wang, Sue-Jane

Publication type:

Article

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

Published in:

Statistics in Biopharmaceutical Research, 2009, v. 1, n. 4, p. 462, doi. 10.1198/sbr.2009.0066

By:

Wang, Sue-Jane

Publication type:

Article

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

Published in:

Statistics in Biopharmaceutical Research, 2009, v. 1, n. 4, p. 457, doi. 10.1198/sbr.2009.0065

By:

Wang, Sue-Jane

Publication type:

Article

TACT method for non-inferiority testing in active controlled trials.

Published in:

Statistics in Medicine, 2003, v. 22, n. 2, p. 227, doi. 10.1002/sim.1316

By:

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

Publication type:

Article

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

Published in:

Statistics in Medicine, 2003, v. 22, n. 2, p. 213, doi. 10.1002/sim.1315

By:

James Hung, H. M.;
Wang, Sue-Jane;
Tsong, Yi;
Lawrence, John;
O'Neil, Robert T.

Publication type:

Article

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

Published in:

Statistics in Medicine, 2001, v. 20, n. 13, p. 1903, doi. 10.1002/sim.820

By:

Wang, Sue-Jane;
James Hung, H. M.;
Tsong, Yi;
Cui, Lu

Publication type:

Article

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

Published in:

Molecular Systems Biology, 2009, v. 5, n. 1, p. 304, doi. 10.1038/msb.2009.53

By:

Liu, Wei;
Ding, Jinhui;
Gibbs, Jesse Raphael;
Wang, Sue Jane;
Hardy, John;
Singleton, Andrew

Publication type:

Article

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

Published in:

Journal of Pharmacokinetics & Pharmacodynamics, 2014, v. 41, n. 6, p. 545, doi. 10.1007/s10928-014-9390-0

By:

Romero, Klaus;
Sinha, Vikram;
Allerheiligen, Sandra;
Danhof, Meindert;
Pinheiro, Jose;
Kruhlak, Naomi;
Wang, Yaning;
Wang, Sue-Jane;
Sauer, John-Michael;
Marier, J.;
Corrigan, Brian;
Rogers, James;
Lambers Heerspink, H.;
Gumbo, Tawanda;
Vis, Peter;
Watkins, Paul;
Morrison, Tina;
Gillespie, William;
Gordon, Mark;
Stephenson, Diane

Publication type:

Article

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

Published in:

Biometrical Journal, 2010, v. 52, n. 6, p. 798, doi. 10.1002/bimj.200900207

By:

Wang, Sue-Jane;
James Hung, H. M.;
O'Neill, Robert T.

Publication type:

Article

Challenges to multiple testing in clinical trials.

Published in:

Biometrical Journal, 2010, v. 52, n. 6, p. 747, doi. 10.1002/bimj.200900206

By:

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

Publication type:

Article

Challenges and regulatory experiences with non-inferiority trial design without placebo arm.

Published in:

Biometrical Journal, 2009, v. 51, n. 2, p. 324, doi. 10.1002/bimj.200800219

By:

Hung, H. M. James;
Wang, Sue-Jane;
O'Neill, Robert

Publication type:

Article

Adaptive patient enrichment designs in therapeutic trials.

Published in:

Biometrical Journal, 2009, v. 51, n. 2, p. 358, doi. 10.1002/bimj.200900003

By:

Wang, Sue-Jane;
James Hung, H. M.;
O'Neill, Robert T.

Publication type:

Article

RejoinderThe views expressed in this article do not necessarily represent those of the U.S. Food and Drug Administration.

Published in:

Biometrical Journal, 2006, v. 48, n. 4, p. 613

By:

H. M. James Hung;
Robert T. O'Neill;
Sue-Jane Wang;
John Lawrence

Publication type:

Article

A Regulatory View on Adaptive/Flexible Clinical Trial DesignThe views expressed in this article do not necessarily represent those of the U.S. Food and Drug Administration.

Published in:

Biometrical Journal, 2006, v. 48, n. 4, p. 565

By:

H. M. James Hung;
Robert T. O'Neill;
Sue-Jane Wang;
John Lawrence

Publication type:

Article

A Regulatory Perspective on Choice of Margin and Statistical Inference Issue in Non-inferiority TrialsThe views expressed in this article do not necessarily represent those of the U.S. Food and Drug Administration.

Published in:

Biometrical Journal, 2005, v. 47, n. 1, p. 28

By:

Sue-Jane Wang;
Robert O'Neill

Publication type:

Article

Testing for Treatment Effects on Subsets of Endpoints.

Published in:

Biometrical Journal, 2002, v. 44, n. 5, p. 541, doi. 10.1002/1521-4036(200207)44:5<541::AID-BIMJ541>3.0.CO;2-0

By:

Chen, James J.;
Wang, Sue-Jane

Publication type:

Article

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

Published in:

Journal of Biopharmaceutical Statistics, 2024, v. 34, n. 5, p. 700, doi. 10.1080/10543406.2023.2269251

By:

Wang, Dong;
Wang, Sue-Jane;
Lababidi, Samir

Publication type:

Article

The i3+3 design for phase I clinical trials.

Published in:

Journal of Biopharmaceutical Statistics, 2020, v. 30, n. 2, p. 294, doi. 10.1080/10543406.2019.1636811

By:

Liu, Meizi;
Wang, Sue-Jane;
Ji, Yuan

Publication type:

Article

Commentary on "Applying CHW method to 2-in-1 design: gain or lose".

Published in:

Journal of Biopharmaceutical Statistics, 2019, v. 29, n. 4, p. 722, doi. 10.1080/10543406.2019.1634088

By:

Cui, Lu;
Hung, H.M. James;
Wang, Sue Jane

Publication type:

Article

Rejoinder to Dr. Cyrus R. Mehta.

Published in:

Journal of Biopharmaceutical Statistics, 2016, v. 26, n. 2, p. 405, doi. 10.1080/10543406.2015.1099542

By:

Hung, H.M. James;
Wang, Sue-Jane;
Yang, Peiling

Publication type:

Article

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

Published in:

Journal of Biopharmaceutical Statistics, 2016, v. 26, n. 1, p. 37, doi. 10.1080/10543406.2015.1092025

By:

Hung, H. M. James;
Wang, Sue-Jane;
Yang, Peiling;
Jin, Kun;
Lawrence, John;
Kordzakhia, George;
Massie, Tristan

Publication type:

Article

Some Challenges With Statistical Inference in Adaptive Designs.

Published in:

Journal of Biopharmaceutical Statistics, 2014, v. 24, n. 5, p. 1059, doi. 10.1080/10543406.2014.925911

By:

Hung, H. M. James;
Wang, Sue-Jane;
Yang, Peiling

Publication type:

Article

Guest Editors’ Note: Special Issue on Subgroup Analysis in Clinical Trials.

Published in:

Journal of Biopharmaceutical Statistics, 2014, v. 24, n. 1, p. 1, doi. 10.1080/10543406.2014.858958

By:

Wang, Sue-Jane;
Dmitrienko, Alex

Publication type:

Article

Standardization for Subgroup Analysis in Randomized Controlled Trials.

Published in:

Journal of Biopharmaceutical Statistics, 2014, v. 24, n. 1, p. 154, doi. 10.1080/10543406.2013.856023

By:

Varadhan, Ravi;
Wang, Sue-Jane

Publication type:

Article

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

Published in:

Journal of Biopharmaceutical Statistics, 2014, v. 24, n. 1, p. 19, doi. 10.1080/10543406.2013.856022

By:

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

Publication type:

Article

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

Published in:

Journal of Biopharmaceutical Statistics, 2012, v. 22, n. 5, p. 879, doi. 10.1080/10543406.2012.701576

By:

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

Publication type:

Article

Sample Size Adaptation in Fixed-Dose Combination Drug Trial.

Published in:

Journal of Biopharmaceutical Statistics, 2012, v. 22, n. 4, p. 679, doi. 10.1080/10543406.2012.676533

By:

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

Publication type:

Article

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

Published in:

Journal of Biopharmaceutical Statistics, 2011, v. 21, n. 4, p. 846, doi. 10.1080/10543406.2011.552878

By:

Wang, Sue-Jane;
James Hung, H.M.;
O'Neill, Robert

Publication type:

Article

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

Published in:

Journal of Biopharmaceutical Statistics, 2010, v. 20, n. 6, p. 1090, doi. 10.1080/10543406.2010.514446

By:

Wang, Sue-Jane

Publication type:

Article

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

Published in:

Journal of Biopharmaceutical Statistics, 2010, v. 20, n. 6, p. 1083, doi. 10.1080/10543406.2010.514461

By:

Wang, Sue-Jane

Publication type:

Article

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

Published in:

Journal of Biopharmaceutical Statistics, 2010, v. 20, n. 6, p. 1098, doi. 10.1080/10543406.2010.514447

By:

Benda, Norbert;
Brannath, Werner;
Bretz, Frank;
Burger, Hans-Ulrich;
Friede, Tim;
Maurer, Willi;
Wang, Sue-Jane

Publication type:

Article

Some Controversial Multiple Testing Problems in Regulatory Applications.

Published in:

Journal of Biopharmaceutical Statistics, 2009, v. 19, n. 1, p. 1, doi. 10.1080/10543400802541693

By:

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

Publication type:

Article

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

Published in:

Journal of Biopharmaceutical Statistics, 2007, v. 17, n. 6, p. 1201, doi. 10.1080/10543400701645405

By:

Hung, H. M. James;
Wang, Sue-Jane;
O'Neill, Robert

Publication type:

Article

Discussion of the "White Paper of the PhRMA Working Group on Adaptive Dose-Ranging Designs".

Published in:

Journal of Biopharmaceutical Statistics, 2007, v. 17, n. 6, p. 1015, doi. 10.1080/10543400701643897

By:

Wang, Sue-Jane

Publication type:

Article

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

Published in:

Journal of Biopharmaceutical Statistics, 2007, v. 17, n. 2, p. 201, doi. 10.1080/10543400601177343

By:

Hung, H. M.James;
Wang, Sue-Jane;
O'Neill, Robert

Publication type:

Article

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

Published in:

Journal of Biopharmaceutical Statistics, 2005, v. 15, n. 4, p. 693, doi. 10.1081/BIP-200062855

By:

James Hung, H. M.;
Cui, Lu;
Wang, Sue-Jane;
Lawrence, John

Publication type:

Article

Adaptive Covariate Adjustment in Clinical Trials.

Published in:

Journal of Biopharmaceutical Statistics, 2005, v. 15, n. 4, p. 605, doi. 10.1081/BIP-200062280

By:

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

Publication type:

Article

Multiple Testing of Noninferiority Hypotheses in Active Controlled Trials#.

Published in:

Journal of Biopharmaceutical Statistics, 2004, v. 14, n. 2, p. 327, doi. 10.1081/BIP-120037183

By:

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

Publication type:

Article

Group Sequential Design and Analysis of Clinical Equivalence Assessment for Generic Nonsystematic Drug Products#.

Published in:

Journal of Biopharmaceutical Statistics, 2004, v. 14, n. 2, p. 359, doi. 10.1081/BIP-120037186

By:

Tsong, Yi;
Zhang, Juan (Joanne);
Wang, Sue Jane

Publication type:

Article

ISSUES RELATED TO SUBGROUP ANALYSIS IN CLINICAL TRIALS.

Published in:

Journal of Biopharmaceutical Statistics, 2002, v. 12, n. 3, p. 347, doi. 10.1081/BIP-120014565

By:

Cui, Lu;
James Hung, H. M.;
Wang, Sue Jane;
Tsong, Yi

Publication type:

Article

MARKET REACTIONS TO THE PASSAGE OF THE FINANCIAL HOLDING COMPANY ACT IN TAIWAN.

Published in:

Pacific Economic Review, 2008, v. 13, n. 4, p. 453, doi. 10.1111/j.1468-0106.2008.00412.x

By:

JANE-SUE WANG;
JING-TWEN CHEN;
PIN-HUANG CHOU

Publication type:

Article

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

Published in:

Pharmaceutical Statistics, 2022, v. 21, n. 3, p. 584, doi. 10.1002/pst.2187

By:

Wang, Dong;
Wang, Sue‐Jane;
Xu, Joshua;
Lababidi, Samir

Publication type:

Article

Sample size for gene expression microarray experiments†The views presented in this paper are those of the authors and not necessarily representing those of the US Food and Drug Administration.

Published in:

Bioinformatics, 2005, v. 21, n. 8, p. 1502, doi. 10.1093/bioinformatics/bti162

By:

Chen-An Tsai;
Sue-Jane Wang;
Dung-Tsa Chen;
James J. Chen

Publication type:

Article

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

Published in:

Theranostics, 2022, v. 12, n. 7, p. 3079, doi. 10.7150/thno.71788

By:

Sue-Jane Wang;
Fotenos, Anthony;
Masters, Shane C.;
Marzella, Louis

Publication type:

Article