Sue Jane Wang

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi request reprint Adaptive statistical analysis following sample size modification based on interim review of effect size
    H M James Hung
    Division of Biometrics I, OB OPaSS CDER, FDA, Rockville, Maryland, USA
    J Biopharm Stat 15:693-706. 2005
  2. ncbi request reprint A regulatory view on adaptive/flexible clinical trial design
    H M James Hung
    Division of Biometrics I, OB OTS CDER FDA, Rockville, MD, USA
    Biom J 48:565-73. 2006
  3. ncbi request reprint 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
  4. ncbi request reprint Statistical considerations for testing multiple endpoints in group sequential or adaptive clinical trials
    H M James Hung
    Division of Biometrics I, OB OTS CDER, FDA, Silver Spring, Maryland 20993 0002, USA
    J Biopharm Stat 17:1201-10. 2007
  5. ncbi request reprint Short of complete abstinence: an analysis exploration of multiple drinking episodes in alcoholism treatment trials
    Sue Jane Wang
    Division of Biometrics II, OB OPaSS CDER FDA, Rockville, Maryland 20857, USA
    Alcohol Clin Exp Res 26:1803-9. 2002
  6. doi request reprint Adaptive enrichment with subpopulation selection at interim: methodologies, applications and design considerations
    Sue Jane Wang
    Office of Biostatistics, OTS CDER, FDA, Silver Spring, MD 20993, USA Electronic address
    Contemp Clin Trials 36:673-81. 2013
  7. doi request reprint Panel forum on multiple comparison procedures: a commentary from a complex trial design and analysis plan
    Sue Jane Wang
    U S Food and Drug Administration, HFD 700, WO 21, MailStop Room 3562, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    Biom J 55:275-93. 2013
  8. doi request reprint Paradigms for adaptive statistical information designs: practical experiences and strategies
    Sue 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
  9. ncbi request reprint Ethnic sensitive or molecular sensitive beyond all regions being equal in multiregional clinical trials
    Sue Jane Wang
    Office of Biostatistics, OTS CDER, Food and Drug Adminstration, Silver Spring, Maryland 20993 0002, USA
    J Biopharm Stat 22:879-93. 2012
  10. doi request reprint Perspectives on the use of adaptive designs in clinical trials. Part I. Statistical considerations and issues
    Sue 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

Detail Information

Publications50

  1. ncbi request reprint Adaptive statistical analysis following sample size modification based on interim review of effect size
    H 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...
  2. ncbi request reprint A regulatory view on adaptive/flexible clinical trial design
    H 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...
  3. ncbi request reprint 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
  4. ncbi request reprint Statistical considerations for testing multiple endpoints in group sequential or adaptive clinical trials
    H M James Hung
    Division of Biometrics I, OB OTS CDER, FDA, Silver Spring, Maryland 20993 0002, USA
    J Biopharm Stat 17:1201-10. 2007
    ....
  5. ncbi request reprint Short of complete abstinence: an analysis exploration of multiple drinking episodes in alcoholism treatment trials
    Sue Jane Wang
    Division of Biometrics II, OB OPaSS CDER FDA, Rockville, Maryland 20857, USA
    Alcohol Clin Exp Res 26:1803-9. 2002
    ....
  6. doi request reprint Adaptive enrichment with subpopulation selection at interim: methodologies, applications and design considerations
    Sue Jane Wang
    Office of Biostatistics, OTS CDER, FDA, Silver Spring, MD 20993, USA Electronic address
    Contemp Clin Trials 36:673-81. 2013
    ..We discuss and articulate design considerations for adaptive enrichment among a dual-composite null hypothesis, a flexible dual-independent null hypothesis and a rigorous dual-independent null hypothesis. ..
  7. doi request reprint Panel forum on multiple comparison procedures: a commentary from a complex trial design and analysis plan
    Sue Jane Wang
    U S Food and Drug Administration, HFD 700, WO 21, MailStop Room 3562, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    Biom J 55:275-93. 2013
    ....
  8. doi request reprint Paradigms for adaptive statistical information designs: practical experiences and strategies
    Sue 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
    ....
  9. ncbi request reprint Ethnic sensitive or molecular sensitive beyond all regions being equal in multiregional clinical trials
    Sue Jane Wang
    Office of Biostatistics, OTS CDER, Food and Drug Adminstration, Silver Spring, Maryland 20993 0002, USA
    J Biopharm Stat 22:879-93. 2012
    ....
  10. doi request reprint Perspectives on the use of adaptive designs in clinical trials. Part I. Statistical considerations and issues
    Sue 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...
  11. doi request reprint An evidential approach to non-inferiority clinical trials
    Sue 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...
  12. ncbi request reprint Biomarker as a classifier in pharmacogenomics clinical trials: a tribute to 30th anniversary of PSI
    Sue 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
    ....
  13. doi request reprint Impacts on type I error rate with inappropriate use of learn and confirm in confirmatory adaptive design trials
    Sue 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...
  14. ncbi request reprint Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset
    Sue 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
    ....
  15. doi request reprint Adaptive patient enrichment designs in therapeutic trials
    Sue 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...
  16. ncbi request reprint Utility of adaptive strategy and adaptive design for biomarker-facilitated patient selection in pharmacogenomic or pharmacogenetic clinical development program
    Sue 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
    ....
  17. doi request reprint Adaptive design clinical trials and trial logistics models in CNS drug development
    Sue 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...
  18. doi request reprint Statistical considerations in evaluating pharmacogenomics-based clinical effect for confirmatory trials
    Sue 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...
  19. doi request reprint Regulatory perspectives on multiplicity in adaptive design clinical trials throughout a drug development program
    Sue 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...
  20. ncbi request reprint Issues with statistical risks for testing methods in noninferiority trial without a placebo ARM
    H 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...
  21. doi request reprint Some controversial multiple testing problems in regulatory applications
    H 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
    ....
  22. ncbi request reprint Adaptive covariate adjustment in clinical trials
    Sue 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...
  23. ncbi request reprint Methodological issues with adaptation of clinical trial design
    H 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...
  24. ncbi request reprint Sample size for identifying differentially expressed genes in microarray experiments
    Sue 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...
  25. pmc The MicroArray Quality Control (MAQC)-II study of common practices for the development and validation of microarray-based predictive models
    Leming 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...
  26. ncbi request reprint Adapting the sample size planning of a phase III trial based on phase II data
    Sue 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
    ....
  27. ncbi request reprint A regulatory perspective on choice of margin and statistical inference issue in non-inferiority trials
    H 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...
  28. doi request reprint Sample size adaptation in fixed-dose combination drug trial
    H 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...
  29. doi request reprint Evaluation of performance of some enrichment designs dealing with high placebo response in psychiatric clinical trials
    Yeh 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
    ....
  30. doi request reprint Trial design issues and treatment effect modeling in multi-regional schizophrenia trials
    Yeh 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...
  31. ncbi request reprint Assessing treatment efficacy in noninferiority trials
    Sue 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...
  32. doi request reprint Challenges and regulatory experiences with non-inferiority trial design without placebo arm
    H 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...
  33. doi request reprint Flexible design clinical trial methodology in regulatory applications
    H 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...
  34. doi request reprint Multiple comparisons in complex clinical trial designs
    H 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...
  35. ncbi request reprint Utility and pitfalls of some statistical methods in active controlled clinical trials
    Sue 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
    ....
  36. ncbi request reprint Evaluation of external RNA controls for the assessment of microarray performance
    Weida 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...
  37. pmc The balance of reproducibility, sensitivity, and specificity of lists of differentially expressed genes in microarray studies
    Leming 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...
  38. pmc A simple and efficient algorithm for genome-wide homozygosity analysis in disease
    Wei 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...
  39. doi request reprint Consideration of regional difference in design and analysis of multi-regional trials
    H 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...
  40. doi request reprint Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant
    Thomas 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
    ....
  41. doi request reprint Challenges to multiple testing in clinical trials
    H 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...
  42. pmc The MicroArray Quality Control (MAQC) project shows inter- and intraplatform reproducibility of gene expression measurements
    Leming 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...
  43. doi request reprint A regulatory perspective on essential considerations in design and analysis of subgroups when correctly classified
    Sue Jane Wang
    a Office of Biostatistics, OTS CDER, Food and Drug Administration, Silver Spring, Maryland, USA
    J Biopharm Stat 24:19-41. 2014
    ..A set of decision rules gives guidance for rigorous subgroup-specific conclusions. ..
  44. doi request reprint Is pulmonary vascular resistance index predictive of exercise tolerance in adult patients with idiopathic pulmonary arterial hypertension
    John 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...
  45. ncbi request reprint Group sequential design and analysis of clinical equivalence assessment for generic nonsystematic drug products
    Yi 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
    ....
  46. ncbi request reprint Sample size for gene expression microarray experiments
    Chen 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
    ..The sample size problem is formulated as: the number of arrays needed in order to achieve the desired fraction of the specified measure at the desired family-wise power at the given type I error and (standardized) effect size...
  47. ncbi request reprint TACT method for non-inferiority testing in active controlled trials
    Sue Jane Wang
    Division of Biometrics II, OB OPaSS CDER FDA, Rockville, MD 20857, USA
    Stat Med 22:227-38. 2003
    ....
  48. ncbi request reprint Multiple testing of noninferiority hypotheses in active controlled trials
    H 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...
  49. ncbi request reprint Some fundamental issues with non-inferiority testing in active controlled trials
    H 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...
  50. ncbi request reprint Pharmacogenomic data submissions to the FDA: clinical pharmacology case studies
    GUALBERTO RUANO
    Genomas LLC, New Haven, CT, USA
    Pharmacogenomics 5:513-7. 2004