U.S. flag An official website of the United States government
  1. Home
  2. About FDA
  3. FDA Organization
  4. Center for Drug Evaluation and Research | CDER
  5. Publications from Office of Biostatistics Staff
  1. Center for Drug Evaluation and Research | CDER

Publications from Office of Biostatistics Staff


Weber B, Hochhaus G, Adams W, Lionberger R, Li B, Tsong Y, Lee SL. A stability analysis of a modified version of the chi-square ratio statistic: implications for equivalence testing of aerodynamic particle size distribution. AAPS J 2013 Jan;15(1):1-9
Dong X, Ding X, Tsong Y. Bayesian approach to assay sensitivity analysis of thorough QT trials. J Biopharm Stat 2013 Jan;23(1):73-81
Tsong Y, Yuan M, Dong X, Wu YT, Shen M. Comparing the response rates for superiority, noninferiority and equivalence testing with multiple-to-one matched binary data. J Biopharm Stat 2013 Jan;23(1):98-109
Chen HC, Tsong Y, Chen JJ. Data mining for signal detection of adverse event safety data. J Biopharm Stat 2013 Jan;23(1):146-60
Tsong Y, Chen J. Editors' note on special issue on medical product safety. J Biopharm Stat 2013 Jan;23(1):1-2
Huang L, Zalkikar J, Tiwari RC. Likelihood ratio test-based method for signal detection in drug classes using FDA's AERS database. J Biopharm Stat 2013 Jan;23(1):178-200
Tsong Y. On the designs of thorough QT/QTc clinical trials. J Biopharm Stat 2013 Jan;23(1):43-56
Levenson MS, Yue LQ. Regulatory issues of propensity score methodology application to drug and device safety studies. J Biopharm Stat 2013 Jan;23(1):110-21
Zhang LJ, Ko CW, Tang SH, Sridhara R. Relationship Between Progression-Free Survival and Overall Survival Benefit: A Simulation Study. Ther Innov Reg Sci 2013 Jan;47(1):95-100
Tsong Y, Sun A, Kang SH. Sample size of thorough QTc clinical trial adjusted for multiple comparisons. J Biopharm Stat 2013 Jan;23(1):57-72
McEvoy BW, Frimpong EY. Testing a noninferiority hypothesis: what to anticipate when the adverse event is rare. J Biopharm Stat 2013 Jan;23(1):122-8
Fourie Zirkelbach J, Jackson AJ, Wang Y, Schuirmann DJ. Use of partial AUC (PAUC) to evaluate bioequivalence--a case study with complex absorption: methylphenidate. Pharm Res 2013 Jan;30(1):191-202
Izem R, Kammerman LA, Komo S. Statistical challenges in drug approval trials that use patient-reported outcomes. Stat Methods Med Res 2013 Feb 21 [Epub ahead of print]
Kordzakhia G, Dmitrienko A. Superchain procedures in clinical trials with multiple objectives. Stat Med 2013 Feb 10;32(3):486-508
Lin L, Hedayat AS, Tang Y. A comparison model for measuring individual agreement. J Biopharm Stat 2013 Mar 11;23(2):322-45
Ho MW, Tu WZ, Ghosh P, Tiwari RC. A Nested Dirichlet Process Analysis of Cluster Randomized Trial Data With Application in Geriatric Care Assessment. J Am Stat Assoc 2013 Mar;108(501):48-8
Florian J, Jadhav PR, Amur S, Ayala R, Harrington P, Mishra P, O'Rear J, Pacanowski M, Robertson S, Singer M, Soon G, Zeng W, Murray J. Boceprevir dosing for late responders and null responders: the role of bridging data between treatment-naive and experienced subjects. Hepatology 2013 Mar;57(3):903-7
Zhang JJ, Chen HY, He K, Tang SH, Justice R, Keegan P, Pazdur R, Sridhara R. Evaluation of Blinded Independent Central Review of Tumor Progression in Oncology Clinical Trials: A Meta-analysis. Ther Innov Reg Sci 2013 Mar;47(2):167-74
Dmitrienko A, D'Agostino RB Sr, Huque MF. Key multiplicity issues in clinical drug development. Stat Med 2013 Mar 30;32(7):1079-111
Liu J, Jadhav PR, Amur S, Fleischer R, Hammerstrom T, Lewis L, Naeger L, O'Rear J, Pacanowski M, Robertson S, Seo S, Soon G, Birnkrant D. Response-guided telaprevir therapy in prior relapsers? The role of bridging data from treatment-naïve and experienced subjects. Hepatology 2013 Mar;57(3):897-902
Dang QY, Zhang J. Validation of QT Interval Correction Methods When a Drug Changes Heart Rate. Ther Innov Reg Sci 2013 Mar;47(2):256-60
Weber B, Lee SL, Lionberger R, Li BV, Tsong Y, Hochhaus G. A sensitivity analysis of the modified chi-square ratio statistic for equivalence testing of aerodynamic particle size distribution. AAPS J 2013 Apr;15(2):465-76
Cohen MH, Chen H, Shord S, Fuchs C, He K, Zhao H, Sickafuse S, Keegan P, Pazdur R. Approval summary: Cetuximab in combination with cisplatin or carboplatin and 5-fluorouracil for the first-line treatment of patients with recurrent locoregional or metastatic squamous cell head and neck cancer. Oncologist 2013;18(4):460-6
Graham DJ, Williams JR, Hsueh YH, Calia K, Levenson M, Pinheiro SP, Macurdy TE, Shih D, Worrall C, Kelman JA. Cardiovascular and mortality risks in Parkinson's disease patients treated with entacapone. Mov Disord 2013 Apr;28(4):490-7
Zhang JJ, Zhang L, Chen H, Murgo AJ, Dodd LE, Pazdur R, Sridhara R. Assessment of audit methodologies for bias evaluation of tumor progression in oncology clinical trials. Clin Cancer Res 2013 May 15;19(10):2637-45
Wang SJ, Hsu JC, Posch M. MCP2011-The 7th international conference on multiple comparison procedures. Biom J 2013 May;55(3):271-4
Sridhara R, Mandrekar SJ, Dodd LE. Missing data and measurement variability in assessing progression-free survival endpoint in randomized clinical trials. Clin Cancer Res 2013 May 15;19(10):2613-20
Ji Y, Wang SJ. Modified toxicity probability interval design: a safer and more reliable method than the 3 + 3 design for practical phase I trials. J Clin Oncol 2013 May 10;31(14):1785-91
Hung HM, Wang SJ. Multiple comparisons in complex clinical trial designs. Biom J 2013 May;55(3):420-9
Alosh M, Huque MF. Multiplicity considerations for subgroup analysis subject to consistency constraint. Biom J 2013 May;55(3):444-62
Wang SJ, Bretz F, Dmitrienko A, Hsu J, Hung HM, Huque M, Koch G. Panel forum on multiple comparison procedures: A commentary from a complex trial design and analysis plan. Biom J 2013 May;55(3):275-93
Axelson M, Liu K, Jiang X, He K, Wang J, Zhao H, Kufrin D, Palmby T, Dong Z, Russell AM, Miksinski S, Keegan P, Pazdur R. U.S. Food and Drug Administration approval: vismodegib for recurrent, locally advanced, or metastatic basal cell carcinoma. Clin Cancer Res 2013 May 1;19(9):2289-93
Jarow JP, Fang X, Hammad TA. Variability of semen parameters with time in placebo treated men. J Urol 2013 May;189(5):1825-9
Gamalo MA, Muthukumarana S, Ghosh P, Tiwari RC. A generalized p-value approach for assessing noninferiority in a three-arm trial. Stat Methods Med Res 2013 Jun;22(3):261-77
Soon G, Zhang Z, Tsong Y, Nie L. Assessing overall evidence from noninferiority trials with shared historical data. Stat Med 2013 Jun 30;32(14):2349-63
Zhang J, Dang Q, Malik M. Baseline correction in parallel thorough QT studies. Drug Saf 2013 Jun;36(6):441-53
Chen J, Florian J, Carter W, Fleischer RD, Hammerstrom TS, Jadhav PR, Zeng W, Murray J, Birnkrant D. Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapies. Gastroenterology 2013 Jun;144(7):1450-5.e2
Nie L, Soon GG, Qi K, Chen Y, Chu H. A Note on Partial Covariate-Adjustment and Design Considerations in Noninferiority Trials When Patient-Level Data are not Available. J Biopharm Stat 2013;23(5):1042-53
Gamalo MA, Tiwari RC, Lavange LM. Bayesian approach to the design and analysis of non-inferiority trials for anti-infective products. Pharm Stat 2013 Aug 5 [Epub ahead of print]
Rothmann M, Koti K, Lee KY, Lu HL, Shen YL, Zhang JJ, Jin M, Zhou H. Evaluating and adjusting for premature censoring of progression-free survival. J Biopharm Stat 2013;23(5):1091-105
De A, Meier K, Tang R, Li M, Gwise T, Gomatam S, Pennello G. Evaluation of heart failure biomarker tests: a survey of statistical considerations. J Cardiovasc Transl Res 2013 Aug;6(4):449-57
Khin NA, Yang P, James Hung HM, Maung-U K, Chen YF, Meeker-O'Connell A, Okwesili P, Yasuda SU, Ball LK, Huang SM, O'Neill RT, Temple R. Regulatory and scientific issues regarding use of foreign data in support of new drug applications in the United States: an FDA perspective. Clin Pharmacol Ther 2013 Aug;94(2):230-42
Hung HMJ, Wang SJ. Statistical Considerations for Noninferiority Trial Designs Without Placebo. Stat Biopharm Res 2013 Aug;5(3):239-47
Huang L, Midthune D, Krapcho M, Zou Z, Horner MJ, Feuer EJ. Adjusting for reporting delay in cancer incidence when combining different sets of cancer registries. Biom J 2013 Sep;55(5):755-70
McEvoy BW, Nandy RR, Tiwari RC. Bayesian approach for clinical trial safety data using an ising prior. Biometrics 2013 Sep;69(3):661-72
Blumenthal GM, Scher NS, Cortazar P, Chattopadhyay S, Tang S, Song P, Liu Q, Ringgold K, Pilaro AM, Tilley A, King KE, Graham L, Rellahan BL, Weinberg WC, Chi B, Thomas C, Hughes P, Ibrahim A, Justice R, Pazdur R. First FDA Approval of Dual Anti-HER2 Regimen: Pertuzumab in Combination with Trastuzumab and Docetaxel for HER2-positive Metastatic Breast Cancer. Clin Cancer Res 2013 Sep 15;19(18):4911-6
Nie L, Zhang ZW, Rubin D, Chu JX. Likelihood reweighting methods to reduce potential bias in noninferiority trials which rely on historical data to make inference. Ann Appl Stat 2013 Sep;7(3):1796-813
Herndon T, Deisseroth AB, Kaminskas E, Kane RC, Koti KM, Rothmann MD, Habtemariam BA, Bullock J, Bray JD, Hawes JH, Palmby TR, Jee J, Adams WM, Mahayni H, Brown J, Dorantes A, Sridhara R, Farrell AT, Pazdur R. U.S. Food and drug administration approval: carfilzomib for the treatment of multiple myeloma. Clin Cancer Res 2013 Sep 1;19(17):4559-63
Margulis AV, Abou-Ali A, Strazzeri MM, Ding Y, Kuyateh F, Frimpong EY, Levenson MS, Hammad TA. Use of selective serotonin reuptake inhibitors in pregnancy and cardiac malformations: a propensity-score matched cohort in CPRD. Pharmacoepidemiol Drug Saf 2013 Sep;22(9):942-51
By K, Qaqish BF, Preisser JS, Perin J, Zink RC. ORTH: R and SAS software for regression models of correlated binary data based on orthogonalized residuals and alternating logistic regressions. Comput Methods Programs Biomed 2013 Oct 31 [Epub ahead of print]
Hausner EA, Hicks KA, Leighton JK, Szarfman A, Thompson AM, Harlow P. Qualification of cardiac troponins for nonclinical use: A regulatory perspective. Regul Toxicol Pharmacol 2013 Oct;67(1):108-14
Rashid MM, McKean JW, Kloke JD. Review of rank-based procedures for multicenter clinical trials. J Biopharm Stat 2013;23(6):1207-27
Wang SJ, Hung HM. Adaptive enrichment with subpopulxxation selection at interim: Methodologies, applications and design considerations. Contemp Clin Trials 2013 Nov;36(2):673-81
Zhang ZW, Wang CG, Nie L, Soon GX. Assessing the heterogeneity of treatment effects via potential outcomes of individual patients. J R Stat Soc Ser C Appl Stat 2013 Nov;62(5):687-704
Graham DJ, Zhou EH, McKean S, Levenson M, Calia K, Gelperin K, Ding X, Macurdy TE, Worrall C, Kelman JA. Cardiovascular and mortality risk in elderly Medicare beneficiaries treated with olmesartan versus other angiotensin receptor blockers. Pharmacoepidemiol Drug Saf 2013 Nov 26 [Epub ahead of print]
Ning YM, Pierce W, Maher VE, Karuri S, Tang S, Chiu HJ, Palmby T, Fourie Zirkelbach J, Marathe D, Mehrotra N, Liu Q, Ghosh D, Cottrell CL, Leighton J, Sridhara R, Ibrahim A, Justice R, Pazdur R. Enzalutamide for treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel: U.S. Food and Drug Administration drug approval summary. Clin Cancer Res 2013 Nov 15;19(22):6067-73
Anello C. Introduction to Part II of the Special Issue Honoring Dr. Robert T. O'Neill's Contribution to Regulatory Statistical Science. Stat Biopharm Res 2013 Nov;5(4):280-1
Sun W, Larsen MD, Lachin JM. Methods for a longitudinal quantitative outcome with a multivariate Gaussian distribution multi-dimensionally censored by therapeutic intervention. Stat Med 2013 Nov 21 [Epub ahead of print]
Permutt T. Multiplicity in Regulatory Statistical Review. Stat Biopharm Res 2013 Nov;5(4):394-401
Huque MF, Dmitrienko A, D'Agostino R. Multiplicity Issues in Clinical Trials With Multiple Objectives. Stat Biopharm Res 2013 Nov;5(4):321-37
Zhou EH, Gelperin K, Levenson MS, Rose M, Hsueh YH, Graham DJ. Risk of acute myocardial infarction, stroke, or death in patients initiating olmesartan or other angiotensin receptor blockers - a cohort study using the Clinical Practice Research Datalink. Pharmacoepidemiol Drug Saf 2013 Nov 28 [Epub ahead of print]
Wang SJ, Brannath W, Brueckner M, Hung HMJ, Koch A. Unblinded Adaptive Statistical Information Design Based on Clinical Endpoint or Biomarker. Stat Biopharm Res 2013 Nov;5(4):293-310
Kluetz PG, Ning YM, Maher VE, Zhang L, Tang S, Ghosh D, Aziz R, Palmby T, Pfuma E, Fourie Zirkelbach J, Mehrotra N, Tilley A, Sridhara R, Ibrahim A, Justice R, Pazdur R. Abiraterone acetate in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer: U.S. Food and drug administration drug approval summary. Clin Cancer Res 2013 Dec 15;19(24):6650-6
Jarow JP, Lerner SP, Kluetz PG, Liu K, Sridhara R, Bajorin D, Chang S, Dinney CP, Groshen S, Morton RA, O'Donnell M, Quale DZ, Schoenberg M, Seigne J, Vikram B. Clinical Trial Design for the Development of New Therapies for Nonmuscle-invasive Bladder Cancer: Report of a Food and Drug Administration and American Urological Association Public Workshop. Urology 2013 Dec 11 [Epub ahead of print]
Mathur AK, Schaubel DE, Zhang H, Guidinger MK, Merion RM. Disparities in Liver Transplantation: The Association Between Donor Quality and Recipient Race/Ethnicity and Sex. Transplantation 2013 Dec 16 [Epub ahead of print]
Alvandi F, Kwitkowski VE, Ko CW, Rothmann MD, Ricci S, Saber H, Ghosh D, Brown J, Pfeiler E, Chikhale E, Grillo J, Bullock J, Kane R, Kaminskas E, Farrell AT, Pazdur R. U.S. Food and Drug Administration Approval Summary: Omacetaxine Mepesuccinate as Treatment for Chronic Myeloid Leukemia. Oncologist 2013 Dec 5 [Epub ahead of print]
Zhang Z, Qu Y, Zhang B, Nie L, Soon G. Use of auxiliary covariates in estimating a biomarker-adjusted treatment effect model with clinical trial data. Stat Methods Med Res 2013 Dec 16 [Epub ahead of print]
Wang SJ, Hung HMJ. A Conditional Adaptive Weighted Test Method for Confirmatory Trials. Ther Innov Reg Sci 2014 Jan;48(1):10-9
Wang SJ, Hung HM. A regulatory perspective on essential considerations in design and analysis of subgroups when correctly classified. J Biopharm Stat 2014 Jan 2;24(1):1-3
Huang L, Guo T, Zalkikar JN, Tiwari RC. A Review of Statistical Methods for Safety Surveillance. Ther Innov Reg Sci 2014 Jan;48(1):51-5
Wang J, Song P, Schrieber S, Liu Q, Xu Q, Blumenthal G, Amiri Kordestani L, Cortazar P, Ibrahim A, Justice R, Wang Y, Tang S, Booth B, Mehrotra N, Rahman A. Exposure-Response Relationship of T-DM1: Insight into Dose Optimization for Patients with HER2-positive Metastatic Breast Cancer. Clin Pharmacol Ther 2014 Jan 31 [Epub ahead of print]
Wang SJ, Dmitrienko A. Guest editors' note: special issue on subgroup analysis in clinical trials. Ther Innov Reg Sci 2014 Jan;48(1):98-108
Kluetz PG, Pierce W, Maher VE, Zhang H, Tang S, Song P, Liu Q, Haber MT, Leutzinger EE, Al-Hakim A, Chen W, Palmby T, Alebachew E, Sridhara R, Ibrahim A, Justice R, Pazdur R. Radium Ra 223 dichloride injection: U.S. Food and Drug Administration Drug Approval Summary. J Biopharm Stat 2014 Jan 2;24(1):19-41
LaVange LM. The Role of Statistics in Regulatory Decision Making. Clin Pharmacol Ther 2014 Jan 31 [Epub ahead of print]
Alvandi F, Kwitkowski VE, Ko CW, Rothmann MD, Ricci S, Saber H, Ghosh D, Brown J, Pfeiler E, Chikhale E, Grillo J, Bullock J, Kane R, Kaminskas E, Farrell AT, Pazdur R. U.S. Food and Drug Administration approval summary: omacetaxine mepesuccinate as treatment for chronic myeloid leukemia. Oncologist 2014 Jan;19(1):94-9
Malik SM, Maher VE, Bijwaard KE, Becker RL, Zhang L, Tang SW, Song P, Liu Q, Marathe A, Gehrke B, Helms W, Hanner D, Justice R, Pazdur R. U.S. Food and Drug Administration Approval: Crizotinib for Treatment of Advanced or Metastatic Non-small Cell Lung Cancer that Is Anaplastic Lymphoma Kinase Positive. Clin Cancer Res 2014 Feb 26 [Epub ahead of print]


Back to Top