Works by Wang, Sue-Jane

Results: 72

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.

Published in:

Journal of Nuclear Medicine, 2022, v. 63, n. 9, p. 1, doi. 10.2967/jnumed.122.264299

By:

Hofling, A. Alex;
Fotenos, Anthony F.;
Gang Niu;
Fallah, Jaleh;
Agrawal, Sundeep;
Wang, Sue-Jane;
Marzella, Libero

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

An evidential approach to non-inferiority clinical trials.

Published in:

Pharmaceutical Statistics, 2011, v. 10, n. 5, p. 440, doi. 10.1002/pst.513

By:

Wang, Sue-Jane;
Blume, Jeffrey D.

Publication type:

Article

Multi-regional clinical trials - What are the challenges?

Published in:

Pharmaceutical Statistics, 2010, v. 9, n. 3, p. 171, doi. 10.1002/pst.457

By:

Wang, Sue-Jane

Publication type:

Article

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

Published in:

Pharmaceutical Statistics, 2010, v. 9, n. 3, p. 217, doi. 10.1002/pst.439

By:

Chen, Yeh-Fong;
Wang, Sue-Jane;
Khin, Ni A.;
Hung, H. M. James;
Laughren, Thomas P.

Publication type:

Article

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

Published in:

Pharmaceutical Statistics, 2010, v. 9, n. 3, p. 173, doi. 10.1002/pst.440

By:

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

Publication type:

Article

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

Published in:

Pharmaceutical Statistics, 2007, v. 6, n. 4, p. 283, doi. 10.1002/pst.316

By:

Wang, Sue-Jane

Publication type:

Article

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

Published in:

Pharmaceutical Statistics, 2007, v. 6, n. 3, p. 227, doi. 10.1002/pst.300

By:

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

Publication type:

Article

Editorial.

Published in:

Pharmaceutical Statistics, 2006, v. 5, n. 3, p. 157, doi. 10.1002/pst.236

By:

Julious, Steven A.;
Wang, Sue-Jane

Publication type:

Article

Methodological issues with adaptation of clinical trial design.

Published in:

Pharmaceutical Statistics, 2006, v. 5, n. 2, p. 99, doi. 10.1002/pst.219

By:

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

Publication type:

Article

Editorial.

Published in:

Pharmaceutical Statistics, 2006, v. 5, n. 2, p. 81, doi. 10.1002/pst.225

By:

Julious, Steven A.;
Wang, Sue-Jane

Publication type:

Article

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

Published in:

Pharmaceutical Statistics, 2006, v. 5, n. 2, p. 85, doi. 10.1002/pst.217

By:

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

Publication type:

Article

Lots Achieved, Lots More To Do.

Published in:

Pharmaceutical Statistics, 2006, v. 5, n. 1, p. 1, doi. 10.1002/pst.201

By:

Furlong, Larry;
Julious, Steven A.;
Wang, Sue-Jane

Publication type:

Article

Modification of Sample Size in Group Sequential Clinical Trials.

Published in:

Biometrics, 1999, v. 55, n. 3, p. 853, doi. 10.1111/j.0006-341X.1999.00853.x

By:

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

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

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

Published in:

2016

By:

Hung, H. M. J.;
Wang, Sue ‐ Jane;
Lawrence, John

Publication type:

journal article

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

Published in:

2015

By:

Wang, Sue‐Jane;
Bretz, Frank;
Dmitrienko, Alex;
Hsu, Jason;
Hung, H. M. James;
Koch, Gary;
Maurer, Willi;
Offen, Walt;
O'Neill, Robert

Publication type:

journal article

Paradigms for adaptive statistical information designs: practical experiences and strategies.

Published in:

Statistics in Medicine, 2012, v. 31, n. 25, p. 3011, doi. 10.1002/sim.5410

By:

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

Publication type:

Article

Flexible design clinical trial methodology in regulatory applications.

Published in:

Statistics in Medicine, 2011, v. 30, n. 13, p. 1519, doi. 10.1002/sim.4021

By:

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

Publication type:

Article

Gastrointestinal Acute Radiation Syndrome: Mechanisms, Models, Markers, and Medical Countermeasures.

Published in:

Radiation Research, 2024, v. 201, n. 6, p. 628, doi. 10.1667/RADE-23-00196.1

By:

Winters, Thomas A.;
Marzella, Libero;
Molinar-Inglis, Olivia;
Price, Paul W.;
Han, Nyun Calvin;
Cohen, Jonathan E.;
Wang, Sue-Jane;
Fotenos, Anthony F.;
Sullivan, Julie M.;
Esker, John I.;
Lapinskas, Paula J.;
DiCarlo, Andrea L.

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

A Bayesian Analysis Suitable for Classroom Presentation.

Published in:

American Statistician, 1988, v. 42, n. 1, p. 75, doi. 10.2307/2685267

By:

Franck, Wallace E.;
Hewett, John E.;
Islam, Mohammed Z.;
Wang, Sue Jane;
Cooperstock, Michael

Publication type:

Article

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

Published in:

Biometrical Journal, 2016, v. 58, n. 1, p. 133, doi. 10.1002/bimj.201400102

By:

Varadhan, Ravi;
Wang, Sue‐Jane

Publication type:

Article

Multiple comparisons in complex clinical trial designs.

Published in:

Biometrical Journal, 2013, v. 55, n. 3, p. 420, doi. 10.1002/bimj.201200048

By:

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

Publication type:

Article

MCP2011-The 7th international conference on multiple comparison procedures.

Published in:

Biometrical Journal, 2013, v. 55, n. 3, p. 271, doi. 10.1002/bimj.201300025

By:

Wang, Sue Jane;
Hsu, Jason C.;
Posch, Martin

Publication type:

Article

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

Published in:

Biometrical Journal, 2013, v. 55, n. 3, p. 275, doi. 10.1002/bimj.201200047

By:

Wang, Sue Jane;
Bretz, Frank;
Dmitrienko, Alex;
Hsu, Jason;
Hung, H. M. James;
Huque, Mohammad;
Koch, Gary

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

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