Research Topics
| Shein Chung ChowSummaryAffiliation: Duke University Medical Center Country: USA Publications
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Detail Information
Publications
On Two-stage Seamless Adaptive Design in Clinical TrialsShein Chung Chow
Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA
J Formos Med Assoc 107:52-60. 2008....- A comparison of moment-based and probability-based criteria for assessment of follow-on biologicsShein Chung Chow
Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina 27705, USA
J Biopharm Stat 20:31-45. 2010..A simulation study was conducted to study relative performance of the two criteria. The feasibility and applicability of the proposed criteria for assessment of biosimilarity of follow-on biologics are discussed... - Adaptive design methods in clinical trials - a reviewShein Chung Chow
Duke University School of Medicine, Durham, North Carolina, USA
Orphanet J Rare Dis 3:11. 2008..Practical issues that are commonly encountered when implementing adaptive design methods in clinical trials are also discussed... - Benefits, challenges and obstacles of adaptive clinical trial designsShein Chung Chow
Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA
Orphanet J Rare Dis 6:79. 2011..It is suggested that the escalating momentum for the use of adaptive design methods in clinical trials be slowed in order to allow time for development of appropriate statistical methodologies... - Statistical methods for assessment of biosimilarity using biomarker dataShein Chung Chow
Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA
J Biopharm Stat 20:90-105. 2010.... - Statistical test for evaluation of biosimilarity in variability of follow-on biologicsTsung Cheng Hsieh
Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA
J Biopharm Stat 20:75-89. 2010..A numerical example is provided to illustrate the proposed methods... - Statistical analysis for two-stage seamless design with different study endpointsShein Chung Chow
Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA
J Biopharm Stat 17:1163-76. 2007..Formula for sample size calculation based on the proposed test statistic is derived. Sample size allocation at the two phases is also discussed... - Statistical assessment of biosimilar productsShein Chung Chow
Duke University School of Medicine, Durham, North Carolina, USA
J Biopharm Stat 20:10-30. 2010..In addition, statistical considerations including design criteria, fundamental biosimilar assumptions, and statistical methods are proposed. The possibility of using genomic data in evaluation of biosimilar products is also explored... - A note on sample size calculation based on propensity analysis in nonrandomized trialsSin Ho Jung
Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA
J Biopharm Stat 17:35-41; discussion 43. 2007..It was shown that the sample size formula derived by Nam (1998) based on the test statistic proposed by Gart (1985) is a special case of the sample size formula derived in this note... - On power and sample size calculation for QT studies with recording replicates at given time pointShein Chung Chow
Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA
J Biopharm Stat 18:483-93. 2008..The proposed approach can also be applied to minimize the cost for a given power... - Statistical methods in translational medicineShein Chung Chow
Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA
J Formos Med Assoc 107:61-73. 2008..Strategies for selection of clinical study endpoints (e.g. absolute changes, relative changes, or responder-defined, based on either absolute or relative change) are reviewed... - Invasive bacterial and fungal infections among hospitalized HIV-infected and HIV-uninfected adults and adolescents in northern TanzaniaJohn A Crump
Division of Infectious Diseases and International Health, Department ofMedicine, Duke University Medical Center, Box 102359, Durham, NC 27710, USA
Clin Infect Dis 52:341-8. 2011..few studies describe patterns of human immunodeficiency virus (HIV) co-infections in African hospitals in the antiretroviral therapy (ART) era... - Stability analysis for drugs with multiple active ingredientsShein Chung Chow
Department of Biostatistics and Bioinformatics, School of Medicine, Duke University, Durham, NC 27705, USA
Stat Med 26:1512-7. 2007..Stability data observed from a traditional Chinese medicine were analysed to illustrate the proposed method... - Ovarian reserve diminished by oral cyclophosphamide therapy for granulomatosis with polyangiitis (Wegener's)Megan E B Clowse
Duke University Medical Center, Durham, North Carolina, USA
Arthritis Care Res (Hoboken) 63:1777-81. 2011..In this study, we assessed the rate of diminished ovarian reserve in women with GPA who received CYC versus methotrexate (MTX)... - On sample size calculation for comparing survival curves under general hypothesis testingSin Ho Jung
Department of Biostatistics and Bioinformatics, Duke University, Durham, NC 27710, USA
J Biopharm Stat 22:485-95. 2012..The proposed methods are illustrated with designing real clinical trials. Through simulations, the modified log-rank test and the derived formula for sample size calculation are shown to have satisfactory small sample performance... - Bridging studies in clinical developmentJen Pei Liu
Department of Statistics, National Cheng Kung University, Tainan, Taiwan
J Biopharm Stat 12:359-67. 2002..In addition, challenges on the establishment of regulatory requirements, the assessment of bridging evidence, and design and analysis of bridging studies are addressed... - Statistical quality control process for traditional Chinese medicineSiu-Keung Tse
Department of Management Sciences, City University of Hong Kong, Hong Kong, China
J Biopharm Stat 16:861-74. 2006..An example concerning the development of a TCM is presented to illustrate the proposed statistical QC method for assessing consistency in raw materials from two sites... - Statistical assessment of QT/QTc prolongation based on maximum of correlated normal random variablesBin Cheng
Department of Biostatistics, Columbia University, New York, New York 10032, USA
J Biopharm Stat 18:494-501. 2008..Simulations indicate that our proposed test has adequate powers... - A hybrid Bayesian adaptive design for dose response trialsMark Chang
Millennium Pharmaceuticals, Inc, Cambridge, Massachusetts, USA
J Biopharm Stat 15:677-91. 2005..The performance of the proposed method was examined in terms of its operating characteristics through computer simulations... - Inference for clinical trials with some protocol amendmentsShein Chung Chow
Division of Biostatistics and Bioinformatics, National Health Research Institutes, Taiwan
J Biopharm Stat 15:659-66. 2005..In this article, we model the population deviations due to protocol amendments using some covariates and study how to develop a valid statistical inference procedure. An example concerning an asthma trial is presented for illustration... - On statistical power for average bioequivalence testing under replicated crossover designsHansheng Wan
StatPlus, Inc, Heston Hall, Yardley, PA 19067, USA
J Biopharm Stat 12:295-309. 2002..Based on the derived power function, formula for sample size calculation for assessment of ABE under a 2 x 2m replicated crossover design is also provided... - Assessing sensitivity and similarity in bridging studiesShein-Chung Chow
StatPlus, Inc, Yardley, PA 19067, USA
J Biopharm Stat 12:385-400. 2002..Guidance for Industry--Statistical Approaches to Establishing Bioequivalence, Center for Drug Evaluation and Research, Food and Drug Administration: Rockville, MD, 2001] assuming that study site is random... - A note on sample size calculation for mean comparisons based on noncentral t-statisticsShein-Chung Chow
StatPlus, Inc, Heston Hall, Suite 206, 1790 Yardley-Langhorne Road, Yardley, PA 19067, USA
J Biopharm Stat 12:441-56. 2002..Useful tables are constructed and some examples are given for illustration... - Tests for inter-subject and total variabilities under crossover designsYonghee Lee
University of Wisconsin Madison, Madison, Wisconsin, USA
J Biopharm Stat 12:503-34. 2002..Several simulation studies were conducted to investigate the finite sample performance of the proposed test. Our simulation results show that the proposed test can control type I error satisfactorily... - Individual bioequivalence testing under 2x3 designsShein-Chung Chow
Statplus Inc, Heston Hall, Suite 206, 1790 Yardley-Langhorne Road, Yardley, PA 19067, USA
Stat Med 21:629-48. 2002..Our conclusions are supported by theoretical considerations and empirical results. Furthermore, a method of determining the sample sizes required for IBE tests to reach a given level of power is proposed... - Mixed noninferiority margin and statistical tests in active controlled trialsHsiao Hui Tsou
Division of Biostatistics and Bioinformatics, National Health Research Institutes, Zhunan Town, Miaoli County, Taiwan
J Biopharm Stat 17:339-57. 2007..Simulation studies were also conducted to assess the type I error rate and the power... - Cross-validation for linear model with unequal variances in genomic analysisLi Li
Clinical Discovery Department, Bristol Myers Squibb, Princeton, New Jersey 08543 4000, USA
J Biopharm Stat 14:723-39. 2004..Several simulations were performed to evaluate the finite samples performances of the proposed methods. An example concerning a breast cancer research is present to illustrate the use of the proposed methods... - Probability lower bounds for USP/NF testsShein-Chung Chow
Statplus Inc, Yardley, PA 19067, USA
J Biopharm Stat 12:79-92. 2002..It is shown that the proposed probability lower bounds are better than the existing ones and are very close to the true probabilities in a broad range of the population mean and variance of the test sample... - A practical approach for comparing means of two groups without equal variance assumptionHansheng Wang
StatPlus, Inc, 1790 Yardley-Langhorne Road, PA 19067, USA
Stat Med 21:3137-51. 2002..The proposed approach is not only simple for constructing the confidence limit, but also provides a simple and accurate formula for sample size calculation... - A Bayesian approach on sample size calculation for comparing meansHansheng Wang
Guanghua School of Management, Peking University, Beijing, China
J Biopharm Stat 15:799-807. 2005..An example is given for illustration purposes... - On the assessment of similarity for dissolution profiles of two drug productsShein-Chung Chow
Stat Plus, Inc, Heston Hall, Yardley, PA 19067, USA
J Biopharm Stat 12:311-21. 2002..An example is presented for illustration... - Adaptive design in clinical research: issues, opportunities, and recommendationsMark Chang
Millennium Pharmaceuticals Inc, Cambridge, MA 02139, USA
J Biopharm Stat 16:299-309; discussion 311-2. 2006..Various seamless designs are investigated. Recommendations are made in the following aspects: study planning, trial monitoring, analysis and reporting, trial simulation, and regulatory perspectives... - On non-inferiority margin and statistical tests in active control trialsShein-Chung Chow
Millennium Pharmaceuticals, Inc, Cambridge, MA 02139, USA
Stat Med 25:1101-13. 2006..An example concerning a cancer trail for testing non-inferiority with the primary study endpoint of the time to disease progression is presented to illustrate the proposed method... - On sample size calculation based on odds ratio in clinical trialsHansheng Wang
StatPlus, Inc, Heston Hall, Suite 206, 1790 Yardley Langhorne Road, Yardley, PA 19067, USA
J Biopharm Stat 12:471-83. 2002..Simulations were performed to assess the adequacy of the sample size calculation formulas. Simulation results were given at the end of the paper... - On the assessment of dose proportionality: a comparison of two slope approachesBin Cheng
Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, NY 10032, USA
J Biopharm Stat 16:385-92. 2006..The two slope approaches are compared under a parallel group design by means of an ANOVA type F-test and other tests. Simulation studies show that the proposed method has a satisfactory small sample performance... - In vitro bioequivalence testingShein-Chung Chow
Statplus Inc, Heston Hall, Suite 206, 1790 Yardley-Langhorne Road, Yardley, PA 19067, USA
Stat Med 22:55-68. 2003..A method for determining the required sample size to achieve a desired power is also proposed. A numerical example is given for illustration... - Examining outlying subjects and outlying records in bioequivalence trialsWenping Wang
Pharsight Corporation, Mountain View, California 94040, USA
J Biopharm Stat 13:43-56. 2003..The results from the simulation study show that the proposed test is more powerful than the Hotelling T2 test... - Assessing bioequivalence using genomic dataShein Chung Chow
National Health Research Institutes, Taiwan
J Biopharm Stat 14:869-80. 2004..Our methods are derived for average, population, and individual bioequivalence... - Adaptive group sequential test for clinical trials with changing patient populationHuaibao Feng
Department of Statistics, University of Wisconsin, Madison, Wisconsin, USA
J Biopharm Stat 17:1227-38. 2007..Statistical powers of the proposed group sequential test are also presented... - Analysis strategies for adaptive designs with multiple endpointsMark Chang
Millennium Pharmaceuticals, Inc, Cambridge, Massachusetts 02139, USA
J Biopharm Stat 17:1189-200. 2007..Practical examples are presented to illustrate the proposed fractal gatekeeper method when analyzing data obtained from an adaptive trial with multiple endpoints... - Sample size determination based on rank tests in clinical trialsHansheng Wang
Guanghua School of Management, Peking University, Beijing, PR China
J Biopharm Stat 13:735-51. 2003..Simulation studies were performed to evaluate the finite samples performance of the derived sample size formulas. The results indicates that the derived methods work well with moderate sample size... - Statistical consideration of adaptive methods in clinical developmentShein Chung Chow
Division of Biostatistics and Bioinformatics, National Health Research Institutes, Taipei, Taiwan
J Biopharm Stat 15:575-91. 2005..Major modifications of trial procedures and/or statistical procedures of on-going trials may result in a totally different trial, which is unable to address the scientific/medical questions that the trial intends to answer... - Analysis of clinical data with breached blindnessShein-Chung Chow
Millennium Pharmaceuticals Inc, Cambridge, MA 02139, U.S.A
Stat Med 23:1185-93. 2004..J. Psychiatry 1982; 139:1487-1489) is used to illustrate the application of the proposed methods... - Stability analysis with discrete responsesShein-Chung Chow
Milliennium Pharmaceuticals, Inc, Cambridge, Massachusetts, USA
J Biopharm Stat 13:451-62. 2003..As a result, the proposed shelf life is applicable to all future batches of the same drug product. Testing for batch-to-batch variation based on discrete responses is also discussed...