Research Topics
| Sue Jane WangSummaryAffiliation: Food and Drug Administration Country: USA Publications
| Collaborators
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Detail Information
Publications
Short of complete abstinence: an analysis exploration of multiple drinking episodes in alcoholism treatment trialsSue Jane Wang
Division of Biometrics II, OB OPaSS CDER FDA, Rockville, Maryland 20857, USA
Alcohol Clin Exp Res 26:1803-9. 2002....- Adaptive covariate adjustment in clinical trialsSue Jane Wang
Division of Biometrics II, OB OPaSS CDER, FDA, HFD 715, Rockville, Maryland, USA
J Biopharm Stat 15:605-11. 2005..We propose an adaptive strategy to achieve this goal if the current data are needed to help the search... - Adaptive statistical analysis following sample size modification based on interim review of effect sizeH M James Hung
Division of Biometrics I, OB OPaSS CDER, FDA, Rockville, Maryland, USA
J Biopharm Stat 15:693-706. 2005..The performance of this adaptive design strategy is assessed by comparing it with a fixed maximum sample size design that is properly adjusted in anticipation of the possible sample size adjustment... - A regulatory view on adaptive/flexible clinical trial designH M James Hung
Division of Biometrics I, OB OTS CDER FDA, Rockville, MD, USA
Biom J 48:565-73. 2006..Up till now, regulatory experience in these designs is very limited. We share some of the challenges... - Discussion of the "White Paper of the PhRMA Working Group on adaptive dose-ranging designs"Sue-Jane Wang
Center for Drug Evaluation and Research, US Food and Drug Administration, Rockvill 20857-0001, Maryland, USA
J Biopharm Stat 17:1015-20; discussion 1029-32. 2007 
Paradigms for adaptive statistical information designs: practical experiences and strategiesSue Jane Wang
Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, U S A
Stat Med 31:3011-23. 2012....- Ethnic sensitive or molecular sensitive beyond all regions being equal in multiregional clinical trialsSue Jane Wang
Office of Biostatistics, OTS CDER, Food and Drug Adminstration, Silver Spring, Maryland 20993 0002, USA
J Biopharm Stat 22:879-93. 2012.... - Perspectives on the use of adaptive designs in clinical trials. Part I. Statistical considerations and issuesSue Jane Wang
Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, Maryland, USA
J Biopharm Stat 20:1090-7. 2010..Part II, capturing the panelists' perspectives given at the panel discussion session, can be found immediately following Part I... - Impacts on type I error rate with inappropriate use of learn and confirm in confirmatory adaptive design trialsSue Jane Wang
OTS CDER, US FDA, Silver Spring, MD 20993 0002, USA
Biom J 52:798-810. 2010..Inappropriate use of any "Learn and Confirm" strategy should not be overlooked... - Statistical considerations in evaluating pharmacogenomics-based clinical effect for confirmatory trialsSue Jane Wang
Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, US FDA, Silver Spring, MD 20993, USA
Clin Trials 7:525-36. 2010..The current practice for seeking genomically favorable patients in randomized controlled clinical trials using genomic convenience samples... - Approaches to evaluation of treatment effect in randomized clinical trials with genomic subsetSue Jane Wang
Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U S Food and Drug Administration, Silver Spring, MD 20993, USA
Pharm Stat 6:227-44. 2007.... - Biomarker as a classifier in pharmacogenomics clinical trials: a tribute to 30th anniversary of PSISue Jane Wang
Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA
Pharm Stat 6:283-96. 2007.... - Regulatory perspectives on multiplicity in adaptive design clinical trials throughout a drug development programSue Jane Wang
Office of Biostatistics, OTS CDER, FDA, Silver Spring, Maryland 20993 0002, USA
J Biopharm Stat 21:846-59. 2011..We assert that maximizing these probabilities would be critical to determine whether the drug development program continues or how to plan the confirmatory trials if the development continues... - An evidential approach to non-inferiority clinical trialsSue Jane Wang
Office of Biostatistics, Office of Translational Sciences, CDER US FDA, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
Pharm Stat 10:440-7. 2011..In situations where the statistical non-inferiority margin is data driven, lower likelihood support interval limits provide plausibly conservative candidate margins... - Utility of adaptive strategy and adaptive design for biomarker-facilitated patient selection in pharmacogenomic or pharmacogenetic clinical development programSue Jane Wang
Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Maryland, USA
J Formos Med Assoc 107:19-27. 2008.... - Adaptive patient enrichment designs in therapeutic trialsSue Jane Wang
Office of Biostatistics, Division of Biometrics I OB, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, USA
Biom J 51:358-74. 2009..The adaptive designs, when applicable, are along the line of efficiency consideration in a drug development program... - Adaptive design clinical trials and trial logistics models in CNS drug developmentSue Jane Wang
Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U S Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
Eur Neuropsychopharmacol 21:159-66. 2011..However, it is controversial to use the simulated type I error rate to address a strong control of the study-wise type I error rate... - Issues with statistical risks for testing methods in noninferiority trial without a placebo ARMH M James Hung
Division of Biometrics I, Office of Biostatistics, OTS CDER, FDA, Silver Spring, MD 20993 0002, USA
J Biopharm Stat 17:201-13. 2007..For the indirect statistical inference, the practical utility of any method that controls only the across-trial Type I error rate at a fixed small level is limited... - Some controversial multiple testing problems in regulatory applicationsH M James Hung
Division of Biometrics I, OB OTS CDER, FDA, Silver Spring, Maryland 20993 0002, USA
J Biopharm Stat 19:1-11; discussion 12-41. 2009.... - Statistical considerations for testing multiple endpoints in group sequential or adaptive clinical trialsH M James Hung
Division of Biometrics I, OB OTS CDER, FDA, Silver Spring, Maryland 20993 0002, USA
J Biopharm Stat 17:1201-10. 2007.... - Sample size for identifying differentially expressed genes in microarray experimentsSue Jane Wang
Division of Biometrics II, Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland 20857, USA
J Comput Biol 11:714-26. 2004..An example dataset is used to illustrate the use of the proposed approach to plan microarray experiments... - Methodological issues with adaptation of clinical trial designH M James Hung
Division of Biometrics I, OB CDER FDA, 10903 New Hampshire Avenue, BLDG 22 Rm 4238, HFD 710, Mail Stop 4105, Silver Spring, MD 20993 0002, USA
Pharm Stat 5:99-107. 2006..Pre-specification of the adaptation rule is important for the practicality consideration. Changing the originally intended hypothesis for testing with the internal data generates great concerns to clinical trial researchers... - A regulatory perspective on choice of margin and statistical inference issue in non-inferiority trialsH M James Hung
Division of Biometrics I, Office of Biostatistics, OPaSS, CDER, FDA, HFD 710, Room 5062, WOC2, 1451 Rockville Pike, Rockville, MD 20852, USA
Biom J 47:28-36; discussion 99-107. 2005..The margin can be a fixed margin or a margin functionally defined. Between-trial differences always exist and need to be properly considered... 
The MicroArray Quality Control (MAQC)-II study of common practices for the development and validation of microarray-based predictive modelsLeming Shi
National Center for Toxicological Research, US Food and Drug Administration, Jefferson, Arkansas, USA
Nat Biotechnol 28:827-38. 2010..The conclusions and recommendations from MAQC-II should be useful for regulatory agencies, study committees and independent investigators that evaluate methods for global gene expression analysis...- Adapting the sample size planning of a phase III trial based on phase II dataSue Jane Wang
Office of Biostatistics, Office of Pharmacoepidemiology and Statistical Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 20993, USA
Pharm Stat 5:85-97. 2006.... - Sample size adaptation in fixed-dose combination drug trialH M James Hung
Division of Biometrics I, OB OTS CDER, U S Food and Drug Administration, Silver Spring, MD 20993 0002, USA
J Biopharm Stat 22:679-86. 2012..This research sheds some light into possible power advantage from such a sample size reallocation at the interim look... - Trial design issues and treatment effect modeling in multi-regional schizophrenia trialsYeh Fong Chen
Division of Biometrics I, HFD 710, Food and Drug Administration, 10903 New HampshireAvenue, Building 21, Room 4610, Silver Spring, MD 20993 0002, USA
Pharm Stat 9:217-29. 2010..When baseline body weight was considered as a covariate in an empiric model, our results indicated that it alone did not seem to be an important factor in explaining regional difference... - Evaluation of performance of some enrichment designs dealing with high placebo response in psychiatric clinical trialsYeh Fong Chen
Division of Biometric I, Office of Biostatistics, Office of Translational Sciences, Center of Drug Evaluation and Research CDER, Food and Drug Administration, Silver Spring, MD 20993 0002, USA
Contemp Clin Trials 32:592-604. 2011.... - Assessing treatment efficacy in noninferiority trialsSue Jane Wang
Division of Biometrics II, Office of Biostatistics, CDER, FDA, Rockville, MD 20857, USA
Control Clin Trials 24:147-55. 2003..The evaluation provides guidance as to what percentage of the control effect needs to be preserved so that through noninferiority testing of effect retention one can assert the treatment efficacy within a desired level of the error rate... - Challenges and regulatory experiences with non-inferiority trial design without placebo armH M James Hung
Division of Biometrics I, OB OTS CDER, US FDA, 10903 New Hampshire Ave, HFD 710, Silver Spring, MD 20993 0002, USA
Biom J 51:324-34. 2009..This work explores an approach for assessing the impact of potential bias due to violation of a key statistical assumption to guide determination of the non-inferiority margin... - Flexible design clinical trial methodology in regulatory applicationsH M James Hung
Division of Biometrics I, Office of Biostatistics, OTS, CDER, Food and Drug Administration, Silver Spring, MD 20994 0002, USA
Stat Med 30:1519-27. 2011..This work presents the biases that may incur under adaptive patient selection designs... - Utility and pitfalls of some statistical methods in active controlled clinical trialsSue Jane Wang
Division of Biometrics II, Office of Biostatistics, Center of Drug Evaluation and Resesarch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, USA
Control Clin Trials 23:15-28. 2002.... - Evaluation of external RNA controls for the assessment of microarray performanceWeida Tong
National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Rd, Jefferson, Arkansas 72079, USA
Nat Biotechnol 24:1132-9. 2006..This multiplatform investigation of the behavior and utility of ERCs provides a basis for articulating specific recommendations for their future use in evaluating assay performance across multiple platforms... - The balance of reproducibility, sensitivity, and specificity of lists of differentially expressed genes in microarray studiesLeming Shi
National Center for Toxicological Research, US Food and Drug Administration, 3900 NCTR Road, Jefferson, AR 72079, USA
BMC Bioinformatics 9:S10. 2008..The resultant variety of existing and emerging methods exacerbates confusion and continuing debate in the microarray community on the appropriate choice of methods for identifying reliable DEG lists... - A simple and efficient algorithm for genome-wide homozygosity analysis in diseaseWei Liu
Laboratory of Neurogenetics, NIA, Porter Neuroscience Building, NIH Main Campus, Bethesda, MD, USA
Mol Syst Biol 5:304. 2009..We demonstrate this method in a publicly available data set for Alzheimer's disease and identify 26 candidate risk loci in the 22 autosomes. In this data set, these loci can explain 75% of the genetic risk variability of the disease... - Challenges to multiple testing in clinical trialsH M James Hung
OB OTS CDER, US FDA, Silver Spring, MD 20993 0002, USA
Biom J 52:747-56. 2010..Then evaluation of statistical power performance should come in to play in the next step to fine tune the selected procedure... - Consideration of regional difference in design and analysis of multi-regional trialsH M James Hung
Division of Biometrics I, OB CDER FDA, Silver Spring, MD 20993 0002, USA
Pharm Stat 9:173-8. 2010..This article presents a number of useful statistical analysis tools for exploration of regional differences and a method that may be worth consideration in designing a multi-regional clinical trial... - Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressantThomas P Laughren
Division of Psychiatry Products, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993, USA
J Clin Psychiatry 72:1166-73. 2011.... - The MicroArray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurementsLeming Shi
National Center for Toxicological Research, US Food and Drug Administration, Jefferson, Arkansas 72079, USA
Nat Biotechnol 24:1151-61. 2006..This study provides a resource that represents an important first step toward establishing a framework for the use of microarrays in clinical and regulatory settings... - Panel forum on multiple comparison procedures: A commentary from a complex trial design and analysis planSue Jane Wang
U S Food and Drug Administration, HFD 700, WO 21, MailStop Room 3562, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA Johns Hopkins University, Baltimore, MD 21218, USA
Biom J 55:275-93. 2013.... - Multiple comparisons in complex clinical trial designsH M James Hung
Division of Biometrics I, OB OTS CDER, US FDA, 10903 New Hampshire Ave, HFD 710, Silver Spring, MD, 20993 0002, USA
Biom J 55:420-9. 2013..A number of viable expanded strategies are stipulated... - Is pulmonary vascular resistance index predictive of exercise tolerance in adult patients with idiopathic pulmonary arterial hypertensionJohn P Lawrence
U S Food and Drug Administration, Silver Spring, MD 20993 002, USA
Contemp Clin Trials 33:1217-24. 2012..In this article, we look at the relationship between walking distance and a hemodynamic variable, pulmonary vascular resistance index (PVRI), from the available trials... - Group sequential design and analysis of clinical equivalence assessment for generic nonsystematic drug productsYi Tsong
Office of Biostatistics Office of Pharmacoepidemiology and Statistical Sciences, Center of Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20857, USA
J Biopharm Stat 14:359-73. 2004.... - TACT method for non-inferiority testing in active controlled trialsSue Jane Wang
Division of Biometrics II, OB OPaSS CDER FDA, Rockville, MD 20857, USA
Stat Med 22:227-38. 2003.... - Sample size for gene expression microarray experimentsChen-An Tsai
Division of Biometry and Risk Assessment, National Center for Toxicological Research, Food and Drug Administration, Jefferson, AR 72079, USA
Bioinformatics 21:1502-8. 2005..But, under more general correlation structures, the beta-binomial model can underestimate the needed samples by about 1-5 arrays. CONTACT: ... - Pharmacogenomic data submissions to the FDA: clinical pharmacology case studiesGUALBERTO RUANO
Genomas LLC, New Haven, CT, USA
Pharmacogenomics 5:513-7. 2004 - Multiple testing of noninferiority hypotheses in active controlled trialsH M James Hung
Division of Biometrics I, Food and Drug Administration, Rockville, Maryland 20852, USA
J Biopharm Stat 14:327-35. 2004..None of these elements can be allowed to be influenced directly or indirectly by any analysis of the noninferiority trial data. Otherwise, the noninferiority analysis may be invalid... - Some fundamental issues with non-inferiority testing in active controlled trialsH M James Hung
Division of Biometrics I, OB OPaSS CDER FDA, Rockville, MD 20857, USA
Stat Med 22:213-25. 2003..When this condition is violated, both the confidence interval approach and the preservation test method may be problematic...