Shein-chung Chow, PhD

Department:
Biostatistics and Bioinformatics

Email Address:
sheinchung.chow@duke.edu

Address:
DUMC Box 2721

Durham, NC 27710

Telephone:
9196687523

Fax Telephone:
9196685888

Research Interests:
My research interest includes statistical methodology development and application in the area of biopharmaceutical statistics such as bioavailability and bioequivalence, clinical trials, bridging studies, medical devices, and translational research/medicine. Most recently, I am interested in statistical methodology development for the use of adaptive design methods in clinical trials and methodology development for assessment of biosimilarity of follow-on biologics. In addition, I am also interested in methodology development for statistical evaluation of traditional Chinese medicine (TCM) clinical trials.

Publications:
2009 -- Chow SC and Chang M. Fixed sequence procedure for adaptive designs with multiple endpoints. Statistical Methods in Medical Research, 2009; To appear.

2009 -- Chow SC and Liu JP. On the assessment of biosimilars in clinical research. Submitted.


2009 -- Chow SC, Lu Q, and Tse SK. Statistical methods for assessment of biosimilarity using biomarker data. Submitted.


2009 -- Chow, S.C., Hsieh, E., Chi, E., and Yang, J. A comparison of moment-based and probability-based criteria for assessment of follow-on biologics. Submitted.

2009 -- Hsiao CF, Tsou HH, Pong A, Liu JP, Lin CH, Chang YJ, and Chow SC. Statistical validation of traditional Chinese diagnostic procedure. Drug Information Journal, 2009; 43: 83-95.

2009 -- Li J, Chi E, Feng C, and Chow SC. Imputation method adjusted for covariates for non-respondents in instruments with application. Journal of Biopharmaceutical Statistics, 19; To appear.

2009 -- Lin M, Hsieh TC, and Chow SC. On center grouping in multicenter clinical trials. Submitted.

2009 -- Liu JP, Lin JR, and Chow SC. Inference on treatment effects for targeted clinical trials under enrichment design. Pharmaceutical Research, 2009; To appear.

2009 -- Liu, J.P., Chow, S.C., and Hsieh, T.C. Deviation from linearity in statistical evaluation of linearity in assay validation. Journal of Chemometrics, 2009; To appear.

2009 -- Lu Q, Tse SK, Chow SC, Chi YC, and Yang LY. Statistical analysis of binary study endpoints in a two-stage seamless design with different durations. Journal of Biopharmaceutical Statistics, 2009; 19: To appear.

2009 -- Lu Q, Tse SK, Chow SC, and Yang J. On assessing bioequivalence using genomic data with model misspecification. Journal of Biopharmaceutical Statistics, 19; To appear.

2009 -- Tse SK, Chow SC, Lu Q, and Cosmatos D. Testing homogeneity of two zero-inflated Poisson populations. Biometrical Journal, 2009; In press.

2008 -- Cheng B, Chow SC, Burt D, and Cosmatos D. Statistical assessment of QT/QTc prolongation based on maximum of correlated normal random variables. Journal of Biopharmaceutical Statistics, 2008; 18: 494-501.

2008 -- Chow SC and Chang M. Adaptive design methods in clinical trials - a review. The Orphanet Journal of Rare Diseases, 2008;3:11-

2008 -- Chow SC and Liu JP. Design and Analysis of Bioavailability and Bioequivalence Studies. 3rd Edition, Chapman Hall/CRC Press, Taylor & Francis, 2008, New York, NY.

2008 -- Chow SC and Tu YH. On two-stage seamless adaptive design in clinical trials. Journal of Formosan Medical Assocaition, 2008; 107: S51-S59.

2008 -- Chow SC, Cheng B, and Cosmatos D. On power and sample size calculation for QT studies with recording replicates at given time point, Journal of Biopharmaceutical Statistics, 2008; 18: 483-493.

2008 -- Chow SC, Tse SK, and Lin M. Statistical methods in translational medicine. Journal of Formosa Medical Assocaition, 2008; 107: S60-S72.

2008 -- Chow, SC, Tse, SK, Yang, C., Cosmatos, D., and Chi, E. Statistical test for ordered categorical data in clinical trials. Drug Information Journal, 2008; 42: 617-624.

2008 -- Cosmatos D and Chow SC. Translational Medicine - Strategies and Statistical Methods. Chapman Hall/CRC Press, Taylor & Francis, 2008, New York, NY.

2008 -- Jung, SH, Kim, C, and Chow, SC. Sample size calculation for the log-rank tests for a multi-arm trial with a control. Journal of the Korean Statistical Society, 2008; 37:11-22.

2008 -- Liu, JP and Chow, SC. Statistical issues on the diagnostics multivariate index assay for targeted clinical trials. Journal of Biopharmaceutical Statistics, 2007; 18: 167-182.

2008 -- Tse SK, Chow SC, and Yang C. Statistical test for one-way/two-way translation in translational medicine. Journal of Formosan Medical Association, 2008; 107: S42-S50.

2008 -- Tsou, HH, Hsiao, CF, Chow, SC, and Liu, JP. Optimal two-stage designs for drug screening trials based on continuous endpoints. Drug Information Journal, 2008; 42: 253-262.

2007 -- Chang, M and Chow, SC.Analysis strategies for adaptive designs with multiple endpoints. Journal of Biopharmaceutical Statistics, 2007; 17: 1189-1200.

2007 -- Chow SC, Lu Q, and Tse SK. Statistical analysis for two-stage adaptive design with different study endpoints. Journal of Biopharmaceutical Statistics, 2007; 17(6): 1163-1176.


2007 -- Chow SC, Shao J, and Wang, H. Sample Size Calculations in Clinical Research. Second edition, Chapman Hall/CRC Press, Taylor & Francis, New York, New York.

2007 -- Chow SC, Shao J. Stability analysis for drugs with multiple ingredients. Statistics in Medicine, 2007; 26: 1512-1517.

2007 -- Chow SC. Book review on Bioequivalence Studies in Drug Development: Methods and Applications, by Hauschke D, Steinijans V, and Pigeot I, John Wiley and Sons, New York, NY, Biometrics, 2007; In press.

2007 -- Chow SC. Statistical Design and Analysis of Stability Studies. Chapman Hall/CRC Press, Taylor & Francis, New York, New York.

2007 -- Feng H, Shao J, and Chow SC. Group sequential test for clinical trials with moving patient population. Journal of Biopharmaceutical Statistics, 2007; 17(6): 1227-1238.

2007 -- Jung SH, Chow SC, and Chi E. A note on sample size calculation based on propensity analysis in non-randomized trials. Journal of Biopharmaceutical Statistics, 2007; 17: 35-41.

2007 -- Lu Q, Chow SC, and Tse, SK. Assessing the consistency of traditional Chinese medicine with multiple correlative active components. Journal of Biopharmaceutical Statistics, 2007; 17(5): 791-808.


2007 -- Shao J, Chow SC. Variable screening in predicting clinical outcome with high-dimensional microarrays. J Multivariate Analysis, 2007; 98: 1529-1538.

2007 -- Tsou HH, Chow SC, Hsiao CF, Yue L, Xu Y, and Lee S. Mixed non-inferiority margin and statistical tests in active controlled trials. Journal of Biopharmaceutical Statistics, 2007; 17: 339-357.

2006 -- Cheng B, Chow SC, Su, WL. On the assessment of dose proportionality: a comparison of two slope approaches. J Biopharm Stat, 2006; 16: 385-392.

2006 -- Chow SC, Chang M. Adaptive Design Methods in Clinical Trials. CRC Press/Chapman Hall/Dekker, Taylor & Francis, New York, New York.

2006 -- Chow SC, Pong A, Chang YW. On traditional Chinese medicine clinical trials. Drug Information Journal, 2006; 40: 395-406.

2006 -- Pubmed # 16345042 -- Chow SC, Shao J. On non-inferiority margin and statistical tests in active control trials.  Stat Med.  2006; 25(7):1101-13.

2006 -- Chow SC. Adaptive design methods in clinical trials. International Chinese Statistical Association Bulletin, January 2006: 37-41.

2006 -- Chow SC. Innovative adaptive clinical trial design. Journal of Foundation of Taiwan Medical Alliance, 2006; 1(4): 37-46.

2006 -- Tse SK, Chang JY, Su WL, Chow SC, Hsiung C, and Lu Q.  Statistical quality control process for traditional Chinese medicine. Journal of Biopharmaceutical Statistics, 2006; 16(6): 861-874.


2005 -- Pubmed # 16022172 -- Chang M, Chow SC. A hybrid Bayesian adaptive design for dose response trials.  J Biopharm Stat.  2005;15(4):677-91.

2005 -- Pubmed # 16022164 -- Chow SC, Chang M, Pong A. Statistical consideration of adaptive methods in clinical development.  J Biopharm Stat.  2005;15(4):575-91.

2005 -- Pubmed # 16022170 -- Chow SC, Shao J. Inference for clinical trials with some protocol amendments.  J Biopharm Stat.  2005;15(4):659-66.

2005 -- Pubmed # 15900586 -- Shao J, Chang M, Chow SC. Statistical inference for cancer trials with treatment switching.  Stat Med.  2005 Jun 30;24(12):1783-90.

2005 -- Pubmed # 16078386 -- Wang H, Chow SC, Chen M. A Bayesian approach on sample size calculation for comparing means.  J Biopharm Stat.  2005;15(5):799-807.

2004 -- Pubmed # 15587969 -- Chow SC, Shao J, Li L. Assessing bioequivalence using genomic data.  J Biopharm Stat.  2004 Nov;14(4):869-80.

2004 -- Pubmed # 15083477 -- Chow SC, Shao J. Analysis of clinical data with breached blindness.  Stat Med.  2004 Apr 30;23(8):1185-93.

2004 -- Lee Y, Shao J, Chow SC. The modified large sample confidence intervals for linear combinations of variance components: extension, theory and application. J Amer Stat Assoc, 2004; 99: 467-478.

2004 -- Pubmed # 15468761 -- Li L, Chow SC, Smith W. Cross-validation for linear model with unequal variances in genomic analysis.  J Biopharm Stat.  2004 Aug;14(3):723-39.

2003 -- Chow SC (Ed). Encyclopedia of Biopharmaceutical Statistics - Revised and Expanded. Second Edition, Marcel Dekker, Inc., New York, New York.

2003 -- Chow SC, Liu JP. Design and Analysis of Clinical Trials - Revised and Expanded, Second Edition, John Wiley & Sons, New York, New York.

2003 -- Pubmed # 12486751 -- Chow SC, Shao J, Wang H. In vitro bioequivalence testing.  Stat Med.  2003 Jan 15;22(1):55-68.

2003 -- Chow SC, Shao J, Wang H. Sample Size Calculation in Clinical Research. Marcel Dekker, Inc., New York, New York.

2003 -- Chow SC, Shao J, Wang H. Statistical tests for population bioequivalence. Statistica Sinica, 2003; 13, 539-554.

2003 -- Pubmed # 12921393 -- Chow SC, Shao J. Stability analysis with discrete responses.  J Biopharm Stat.  2003 Aug;13(3):451-62.

2003 -- Pubmed # 14584719 -- Wang H, Chen B, Chow SC. Sample size determination based on rank tests in clinical trials.  J Biopharm Stat.  2003 Nov;13(4):735-51.

2003 -- Pubmed # 12635902 -- Wang W, Chow SC. Examining outlying subjects and outlying records in bioequivalence trials.  J Biopharm Stat.  2003 Feb;13(1):43-56.

2002 -- Pubmed # 12448579 -- Chow SC, Shao J, Hu OY. Assessing sensitivity and similarity in bridging studies.  J Biopharm Stat.  2002 Aug;12(3):385-400.

2002 -- Pubmed # 12477068 -- Chow SC, Shao J, Wang H. A note on sample size calculation for mean comparisons based on noncentral t-statistics.  J Biopharm Stat.  2002 Nov;12(4):441-56.

2002 -- Pubmed # 11870806 -- Chow SC, Shao J, Wang H. Individual bioequivalence testing under 2x3 designs.  Stat Med.  2002 Mar 15;21(5):629-48.

2002 -- Pubmed # 12146721 -- Chow SC, Shao J, Wang H. Probability lower bounds for USP/NF tests.  J Biopharm Stat.  2002 Feb;12(1):79-92.

2002 -- Pubmed # 12392865 -- Chow SC, Shao J. A note on statistical methods for assessing therapeutic equivalence.  Control Clin Trials.  2002 Oct;23(5):515-20.

2002 -- Pubmed # 12448573 -- Chow SC, Shao J. On the assessment of similarity for dissolution profiles of two drug products.  J Biopharm Stat.  2002 Aug;12(3):311-21.

2002 -- Chow SC, Shao J. Statistics in Drug Research - Methodologies and Recent Development. Marcel Dekker, Inc., New York, New York.

2002 -- Pubmed # 12477072 -- Lee Y, Shao J, Chow SC, Wang H. Tests for inter-subject and total variabilities under crossover designs.  J Biopharm Stat.  2002 Nov;12(4):503-34.

2002 -- Pubmed # 12448577 -- Liu JP, Chow SC. Bridging studies in clinical development.  J Biopharm Stat.  2002 Aug;12(3):359-67.

2002 -- Pubmed # 12111908 -- Shao J, Chow SC. Reproducibility probability in clinical trials.  Stat Med.  2002 Jun 30;21(12):1727-42.

2002 -- Pubmed # 12448572 -- Wan H, Chow SC. On statistical power for average bioequivalence testing under replicated crossover designs.  J Biopharm Stat.  2002 Aug;12(3):295-309.

2002 -- Pubmed # 12477070 -- Wang H, Chow SC, Li G. On sample size calculation based on odds ratio in clinical trials.  J Biopharm Stat.  2002 Nov;12(4):471-83.

2002 -- Pubmed # 12369087 -- Wang H, Chow SC. A practical approach for comparing means of two groups without equal variance assumption.  Stat Med.  2002 Oct 30;21(20):3137-51.

2001 -- Pubmed # 11381568 -- Chow SC, Wang H. On sample size calculation in bioequivalence trials.  J Pharmacokinet Pharmacodyn.  2001 Apr;28(2):155-69.

2001 -- Shao J, Chow SC. Drug shelf life estimation. Statistica Sinica, 2001; 11, 737-745.

2001 -- Pubmed # 11304739 -- Shao J, Chow SC. Two-phase shelf-life estimation.  Stat Med.  2001 Apr 30;20(8):1239-48.

2000 -- Chow SC, Liu JP. Design and Analysis of Bioavailability and Bioequivalence Studies - Revised and Expanded, Second Edition, Marcel Dekker, Inc., New York, New York.

2000 -- Pubmed # 10790678 -- Chow SC, Shao J, Ho HT. On statistical analysis for placebo-challenging designs in clinical trials.  Stat Med.  2000 Apr 30;19(8):1029-37.

2000 -- Pubmed # 11033572 -- Shao J, Chow SC, Wang B. The bootstrap procedure in individual bioequivalence.  Stat Med.  2000 Oct 30;19(20):2741-54.

1999 -- About 105 research publications and 5 books prior to 2000 (not listed here).