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James Hung

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Publications

TOP 3
H M James Hung; Sue-Jane Wang
Multiple comparisons in complex clinical trial designs.
Sue-Jane Wang; Frank Bretz; Alex Dmitrienko; Jason Hsu; H M James Hung; Mohammad Huque; Gary Koch
Panel forum on multiple comparison procedures: a commentary from a complex trial design and analysis plan.
John Lawrence; Steve Bai; H M James Hung; Robert O'Neill
Regional treatment effects in studies of cardiorenal drugs: a summary of recent clinical trials.

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All Publications

2013: H M James Hung; Sue-Jane Wang
Multiple comparisons in complex clinical trial designs.
Biometrical journal. Biometrische Zeitschrift 2013;55(3):420-9.
2013: Sue-Jane Wang; Frank Bretz; Alex Dmitrienko; Jason Hsu; H M James Hung; Mohammad Huque; Gary Koch
Panel forum on multiple comparison procedures: a commentary from a complex trial design and analysis plan.
Biometrical journal. Biometrische Zeitschrift 2013;55(3):275-93.
2012: John Lawrence; Steve Bai; H M James Hung; Robert O'Neill
Regional treatment effects in studies of cardiorenal drugs: a summary of recent clinical trials.
Journal of the American College of Cardiology 2012;60(12):1117-8.
2011: Thomas Laughren; Jee Eun Lee; Robert L Levin; Cheri Y Lindberg; Mitchell Mathis; Barry N Rosloff; Robert J Temple; Ellis F Unger; Sue-Jane Wang; Yaning Wang; Peiling Yang; Bei Yu; Huixia Zhang; Li Zhang; Atul Bhattaram; Phillip V Dinh; Linda Fossom; Jogarao V S Gobburu; H M James Hung; Violetta Klimek; Issam Zineh
Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant.
The Journal of clinical psychiatry 2011;72(9):1166-73.
2011: Yeh-Fong Chen; Yang Yang; H M James Hung; Sue-Jane Wang
Evaluation of performance of some enrichment designs dealing with high placebo response in psychiatric clinical trials.
Contemporary clinical trials 2011;32(4):592-604.
2011: H M James Hung; Sue-Jane Wang; Robert O'Neill
Flexible design clinical trial methodology in regulatory applications.
Statistics in medicine 2011;30(13):1519-27.
2011: Sue-Jane Wang; H M James Hung; Robert O'Neill
Adaptive design clinical trials and trial logistics models in CNS drug development.
European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology 2011;21(2):159-66.
2010: Yeh-Fong Chen; Sue-Jane Wang; Ni A Khin; H M James Hung; Thomas Laughren
Trial design issues and treatment effect modeling in multi-regional schizophrenia trials.
Pharmaceutical statistics 2010;9(3):217-29.
2010: H M James Hung; Sue-Jane Wang; Robert T O'Neill
Consideration of regional difference in design and analysis of multi-regional trials.
Pharmaceutical statistics 2010;9(3):173-8.
2009: H M James Hung; Sue-Jane Wang; Robert O'Neill
Challenges and regulatory experiences with non-inferiority trial design without placebo arm.
Biometrical journal. Biometrische Zeitschrift 2009;51(2):324-34.
2009: Ohidul Siddiqui; H M James Hung; Robert O'Neill
MMRM vs. LOCF: a comprehensive comparison based on simulation study and 25 NDA datasets.
Journal of biopharmaceutical statistics 2009;19(2):227-46.
2009: H M James Hung; Sue-Jane Wang
Some controversial multiple testing problems in regulatory applications.
Journal of biopharmaceutical statistics 2009;19(1):1-11; discussion 12-41.
2008: H M James Hung
Considerations in adapting clinical trial design.
Journal of the Formosan Medical Association = Taiwan yi zhi 2008;107(12 Suppl):14-8.
2007: Sue-Jane Wang; Robert T O'Neill; H M James Hung
Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset.
Pharmaceutical statistics 2007;6(3):227-44.
2007: H M James Hung; Sue-Jane Wang; Robert O'Neill
Statistical considerations for testing multiple endpoints in group sequential or adaptive clinical trials.
Journal of biopharmaceutical statistics 2007;17(6):1201-10.
2007: H M James Hung; Sue-Jane Wang; Robert O'Neill
Issues with statistical risks for testing methods in noninferiority trial without a placebo ARM.
Journal of biopharmaceutical statistics 2007;17(2):201-13.
2006: H M James Hung; Robert T O'Neill; Sue-Jane Wang; John Lawrence
A regulatory view on adaptive/flexible clinical trial design.
Biometrical journal. Biometrische Zeitschrift 2006;48(4):565-73.
2006: H M James Hung; Sue-Jane Wang; Robert T O'Neill
Methodological issues with adaptation of clinical trial design.
Pharmaceutical statistics 2006;5(2):99-107.
2006: Sue-Jane Wang; H M James Hung; Robert T O'Neill
Adapting the sample size planning of a phase III trial based on phase II data.
Pharmaceutical statistics 2006;5(2):85-97.
2005: H M James Hung; Sue-Jane Wang; Robert O'Neill
A regulatory perspective on choice of margin and statistical inference issue in non-inferiority trials.
Biometrical journal. Biometrische Zeitschrift 2005;47(1):28-36; discussion 99-107.
2005: H M James Hung; Lu Cui; Sue-Jane Wang; John Lawrence
Adaptive statistical analysis following sample size modification based on interim review of effect size.
Journal of biopharmaceutical statistics 2005;15(4):693-706.
2005: Sue-Jane Wang; H M James Hung
Adaptive covariate adjustment in clinical trials.
Journal of biopharmaceutical statistics 2005;15(4):605-11.
2004: H M James Hung; Sue-Jane Wang
Multiple testing of noninferiority hypotheses in active controlled trials.
Journal of biopharmaceutical statistics 2004;14(2):327-35.
2003: Sue-Jane Wang; H M James Hung
Assessing treatment efficacy in noninferiority trials.
Controlled clinical trials 2003;24(2):147-55.
2003: Yi Tsong; Sue Jane Wang; H M James Hung; Lu Cui
Statistical issues on objective, design, and analysis of noninferiority active-controlled clinical trial.
Journal of biopharmaceutical statistics 2003;13(1):29-41.
2003: Sue-Jane Wang; H M James Hung
TACT method for non-inferiority testing in active controlled trials.
Statistics in medicine 2003;22(2):227-38.
2002: Lu Cui; H M James Hung; Sue Jane Wang; Yi Tsong
Issues related to subgroup analysis in clinical trials.
Journal of biopharmaceutical statistics 2002;12(3):347-58.
2002: Sue-Jane Wang; H M James Hung; Yi Tsong
Utility and pitfalls of some statistical methods in active controlled clinical trials.
Controlled clinical trials 2002;23(1):15-28.
2001: S J Wang; H M James Hung; Yi Tsong; L Cui
Group sequential test strategies for superiority and non-inferiority hypotheses in active controlled clinical trials.
Statistics in medicine 2001;20(13):1903-12.
2000: H M James Hung
Evaluation of a combination drug with multiple doses in unbalanced factorial design clinical trials.
Statistics in medicine 2000;19(16):2079-87.
1997: S J Wang; H M James Hung
Large sample tests for binary outcomes in fixed-dose combination drug studies.
Biometrics 1997;53(2):498-503.
1997: H M James Hung; Robert T O'Neill; P Bauer; K Köhne
The behavior of the P-value when the alternative hypothesis is true.
Biometrics 1997;53(1):11-22.
1995: H M James Hung; G Y Chi; Robert T O'Neill
Efficacy evaluation for monotherapies in two-by-two factorial trials.
Biometrics 1995;51(4):1483-93.
1993: H M James Hung; G Y Chi; R J Lipicky
Testing for the existence of a desirable dose combination.
Biometrics 1993;49(1):85-94.