ࡱ> []XYZ[ 8bjbjSS B1r\1r\՛bn&n&n&n&n&&&&8&l&*&"*+4+++,,,$n&U,,UUn&n&++!c!c!cU^ n&+n&+!cU!c!c;0߷+B^kN0"&L`NL߷߷Ln& ,L:6 !c#E,OM0,,,a0,,,"UUUUL,,,,,,,,,> 4%: Anastasia Ivanova Department of Biostatistics University of North Carolina at Chapel HillPRIVATE  3103-C McGavran-Greenberg Hall, CB # 7420 Chapel Hill, NC 27599-7420 PRIVATE Work: (919) 8438086tc \l 2 "Work\: (202) 6874055" Fax: (919) 9663802 PRIVATE E-mail:  HYPERLINK mailto:aivanova@bios.unc.edu aivanova@bios.unc.edu PRIVATE Educationtc \l 1 "Education" PRIVATE Ph.D. in Statistics, 1998 tc \l 1 "Ph.D. in Statistics, 1998 " PRIVATE University of Maryland Baltimore County tc \l 1 "University of Maryland Graduate School " PRIVATE Dissertation Advisor: Professor W. F. Rosenbergertc \l 1 "Dissertation Advisor\: Professor W. F. Rosenberger" Dissertation title: A Birth and Death Urn for Randomized Clinical Trials PRIVATE Ph.D. in Mathematics, 1992 tc \l 1 "Ph.D. in Mathematics, 1992 " PRIVATE St. Petersburg State University, St. Petersburg, Russia tc \l 3 "St. Petersburg State University, St. Petersburg, Russia " PRIVATE Dissertation Advisor: Professor S. M. Ermakovtc \l 3 "Dissertation Advisor\: Professor S. M. Ermakov" Dissertation title: Stochastic Stability of Algorithms when Solving Partial Differential Equations with the Monte Carlo Method M.S. in Mathematics, 1988 PRIVATE St. Petersburg State University, St. Petersburg, Russia tc \l 3 "St. Petersburg State University, St. Petersburg, Russia " Professional ExperiencePRIVATE  tc \l 1 "Professional Experience" Associate Professor Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill 2006 Present Member Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill 2001 Present Assistant Professor Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill 1999 - 2006 Assistant Professor Department of Epidemiology and Biostatistics, Case Western Reserve University Cleveland, OH 1998 1999 Biostatistician Lombardi Cancer Center, Georgetown University, Washington, DC 1998 1998 Statistician Intern PRIVATE Food and Drug Administration, Center of Biologics Evaluation and tc \l 1 "Food and Drug Administration, Center of Biologics Evaluation and "PRIVATE Research, Rockville, MDtc \l 1 "Research, Rockville, MD 208521448 " PRIVATE  1997  1998 tc \l 1 " January 1997  January 1998 " Honors and Awards 1983 1988 Honor student scholarship, Department of Mathematics, St. Petersburg State University, St. Petersburg, Russia 2003 2008 Fellowship, Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill 2006 2007 Stanley S. Schor scholarship from Merck Research Laboratories to work on Adaptive Designs Bibliography Peer-reviewed publications, Statistical Methods Ivanova, A., Tamura, R.N. (2013). A two-way enriched clinical trial design: combining advantages of placebo lead-in and randomized withdrawal. Statistical Methods in Medical Research, available in Early View. Ivanova, A, Rosner, G.L., Marchenko, O., Parke, T., Perevozskaya, I., Wang, Y. Advances in statistical approaches in oncology drug development. Therapeutic Innovation and Regulatory Science, in press. Bear, L., Ivanova, A. (2013). When should the sequential parallel comparison design be used in clinical trials? Clinical Investigation, in press Ivanova, A., Xiao+, C. (2013). Dose-finding when the target dose is on a plateau of a dose-response curve. Pharmaceutical Statistics, available in Early View. Ivanova, A, Monaco, J, Stinchcombe, T. (2012). Efficient designs for phase II oncology trials with ordinal outcome. Statistics and Its Interface, 5, 463-469. Ivanova, A., Xiao+, C., Tymofyeyev, Y. (2012). Two-stage designs for Phase 2 dose-finding trials. Statistics in Medicine, 31, 28722881. Xiao+, C., Ivanova, A. (2012). Adaptive isotonic estimation of the minimum effective and peak doses in presence of covariates. Journal of Statistical Planning and Inference, 142, 1899-1907. PMC3375738 Ivanova, A., Qaqish, B.F., Schoenfeld, D. (2011). Optimality, sample size and power calculations for the sequential parallel comparison design. Statistics in Medicine, 30, 2793-2803. Ivanova, A., Liu, K., Snyder, E., Snavely, D. (2009). An adaptive design for identifying the dose with the best efficacy/tolerability profile with application to a crossover dose-finding study. Statistics in Medicine, 28, 2941-2951. PMC2772210 Ivanova, A., Murphy, M. (2009). An adaptive first in man dose-escalation study of NGX267: Statistical, clinical, and operational considerations. Journal of Biopharmaceutical Statistics, 19, 247-255. Ivanova, A., Flournoy, N. (2009). Comparison of isotonic designs for dose-finding. Statistics in Biopharmaceutical Research, 1, 101-107. PMC2821065 Ivanova, A., Kim+, S. (2009). Dose-finding for binary ordinal and continuous outcomes with monotone objective function: a unified approach. Biometrics, 65, 307-315. PMC2819822. Zohar, S, Lian, Q., Levy, V., Cheung, K., Ivanova, A., Chevret, S. (2008). Quality assessment of phase I dose-finding cancer trials: Proposal of a checklist. Clinical Trials, 5, 478-486. PMC2819819. Ivanova, A., Bolognese, J., Perevozskaya, I. (2008). Adaptive design based on t-statistic for dose-response trials. Statistics in Medicine, 27, 1581-1592. PMC2825484 Salama, I., Ivanova, A., Qaqish, B.F. (2008). Efficient generation of constrained block allocation sequences. Statistics in Medicine, 27, 1421-1428. Ivanova, A., Flournoy, N., Chung+, Y. (2007). Cumulative cohort design for dose-finding. Journal of Statistical Planning and Inference, 137, 2316-2317. Ivanova, A. (2006). Escalation, up-and-down and A+B designs for dose-finding trials. Statistics in Medicine, 25, 3668-3678. Qaqish, B.F., Ivanova, A. (2006). Multivariate logistic models. Biometrika, 93, 4, 1011-1017. Ivanova, A., Wang+, K. (2006). Bivariate isotonic design for dose-finding with ordered groups. Statistics in Medicine, 25, 2018-2026. Ivanova, A. (2006). Urn designs with immigration: useful connection with continuous time stochastic processes. Journal of Statistical Planning and Inference, 136, 1836-1844. Ivanova, A., Biswas, A., Lurie, A. (2006). Response adaptive designs for continuous outcomes. Journal of Statistical Planning and Inference, 136, 1845-1852. Coad, S., Ivanova, A. (2005). Sequential adaptive urn designs with elimination for comparing K>2 treatments. Statistics in Medicine, 24, 1995-2009. Coad, S., Ivanova, A. (2005). The use of triangular test with response-adaptive treatment allocation. Statistics in Medicine, 24, 1483-1493. Ivanova, A., Barrier+, R., Berger, V.W. (2005). Adjusting for observable selection bias in block randomized trials. Statistics in Medicine, 24, 1537-1546. Ivanova, A., Qaqish, B.F., Schell, M.J. (2005). Continuous toxicity monitoring in phase I trials in oncology. Biometrics, 61, 540-545. Wang+, K., Ivanova, A. (2005). Two-dimensional dose finding in discrete dose space. Biometrics, 61, 217-222. Berger, V.W., Zhou, Y., Ivanova, A., Tremmel, L. (2004). Adjusting for ordinal covariates by inducing a partial ordering. Biometrical Journal, 46, 48-55. Ivanova, A., Wang+, K. (2004). A nonparametric approach to the design and analysis of two-dimensional dose-finding trials. Statistics in Medicine, 23, 1861-1870. Ivanova, A. (2003). A new dose-finding design for bivariate outcomes. Biometrics, 59, 1003-1009. Ivanova, A. (2003). A play-the-winner-type urn design with reduced variability. Metrika, 58, 1-13. Ivanova, A., Haghighi, A.M., Mohanti, S.G., Durham, S.D. (2003). Improved up-and-down designs for phase I trials. Statistics in Medicine, 22, 69-82. Berger, V.W., Ivanova, A., Knoll, M. (2003). Minimizing predictability while retaining balance trough the use of less restrictive randomization procedures. Statistics in Medicine, 22, 3017-3028. Berger, V.W., Ivanova, A. (2002). Adaptive test for ordered categorical data. Journal of Modern Applied Statistical Methods, 1, 269-280. Berger, V.W., Ivanova, A. (2002). The bias of linear rank tests when testing for stochastic order in ordered categorical data. Journal of Statistical Planning and Inference, 107, 237-247. Coad, D.S., Ivanova, A. (2001). Bias calculations for adaptive designs. Sequential Analysis, 20, 91-116. Ivanova, A., Berger, V.W. (2001). Drawbacks of integer scoring of ordered categorical data. Biometrics, 57, 567-570. Ivanova A., Flournoy, N. (2001). A birth and death urn for ternary outcomes: Stochastic processes applied to urn models. In Probability and Statistical Models with Applications. (Charalambides, C.A., Koutras, M.V., Balakrishnan, N., eds.), Chapman and Hall/CRC, Boca Raton, 583-600. Ivanova, A., Rosenberger, W.F. (2001). Adaptive designs for clinical trials with highly successful treatments. Drug Information Journal, 35, 1087-1093. Rosenberger, W. F., Stallard, N., Ivanova, A., Harper, C., Ricks, M. (2001). Optimal adaptive designs for binary response trials. Biometrics, 57, 833-837. Ivanova, A., Rosenberger, W.F. (2000). A Comparison of urn designs for randomized clinical trials of K>2 treatments. Journal of Biopharmaceutical Statistics, 10, 1, 93-107. Ivanova, A., Rosenberger, W.F., Durham S.D. Flournoy, N. (2000). A birth and death urn for randomized clinical trials. Sankhya B, 62, 104-118. Berger, V.W., Permutt, T., Ivanova, A. (1998). The convex hull test for ordered categorical data. Biometrics, 54, 1541-1550. Ermakov, S.M., Ivanova, A. (1991). Stochastic stability of difference schemes. Vestnik, Mathematics Series, 24, 1, 3640. Barabanov, A.E., Ivanova, A. (1991). Minimax control of a discrete object with mixed perturbations. Automation and Remote Control, 54, 4, 211. Barabanov, A.E., Ivanova, A. (1990). Minimax control of a nonminimally phased object with combination perturbations. Vestnik, Mathematics Series, 23, 1, 1015. +student co-author Peer-reviewed publications, Public Health and Medicine Rossi et al. Detection of sentinel lymph nodes for endometrial cancer with robotic assisted fluorescence imaging: cervical versus hysteroscopic injection. International Journal of Gynecological Cancer, in press. Bhatnagar, S, Hoberman, A, Kearney, DH, Shaikh, N, Moxey-Mims, MM, Chesney, RW, Carpenter, MA, Greenfield, SP, Keren, E, Mattoo, TK, Mathews, R, Gravens-Mueller, L, Ivanova, A. Development and impact of an intervention to boost recruitment in a multi-center pediatric randomized clinical trial. Clinical Pediatrics, in press.  HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=Raftery%20L%5BAuthor%5D&cauthor=true&cauthor_uid=22547007" Raftery L,  HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=Tepper%20JE%5BAuthor%5D&cauthor=true&cauthor_uid=22547007" Tepper JE,  HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=Goldberg%20RM%5BAuthor%5D&cauthor=true&cauthor_uid=22547007" Goldberg RM,  HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=Blackstock%20AW%5BAuthor%5D&cauthor=true&cauthor_uid=22547007" Blackstock AW,  HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=Aklilu%20M%5BAuthor%5D&cauthor=true&cauthor_uid=22547007" Aklilu M,  HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=Bernard%20SA%5BAuthor%5D&cauthor=true&cauthor_uid=22547007" Bernard SA,  HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=Ivanova%20A%5BAuthor%5D&cauthor=true&cauthor_uid=22547007" Ivanova A,  HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=Davies%20JM%5BAuthor%5D&cauthor=true&cauthor_uid=22547007" Davies JM,  HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=O%27Neil%20BH%5BAuthor%5D&cauthor=true&cauthor_uid=22547007" O'Neil BH. (2013). A Two-cohort Phase 1 study of weekly oxaliplatin and gemcitabine, then oxaliplatin, gemcitabine, and erlotinib during radiotherapy for unresectable pancreatic carcinoma. American Journal of Clinical Oncology. In press. Kimple, RJ, Horton, JK, Sartor, CI, Halle, J, Carey, L, Ollila, DW, Ivanova, A, Chiu, WM, Shields, JM, Livasy, CA, Dees, C. (2012). Phase I study and biomarker analysis of lapatinib and concurrent radiation for locally advanced breast cancer. The Oncologist, 17(12), 1496-503. Foster, M.C., Amin, C., Voorhees, P.M., van Deventer, H.W., Richards, K.L., Ivanova, A., Whitman, J., Chiu, W.M., Barr, N.D., Shea, T. (2012). A Phase I, dose escalation study of clofarabine in combination with fractionated gemtuzumab ozogamicin in patients with refractory or relapsed acute myeloid leukemia. Leukemia and Lymphoma, 53(7), 1331-7, PMID: 22149206 Weiner, D.E., Carpenter, M.A., Levey, A.S., Ivanova, A., Cole, E.H., Hunsicker, L., Kasiske, B.L., Kim, J.S., Kusek, J.W., Bostom, A.G. (2012). Kidney function and risk of cardiovascular disease and mortality in stable kidney transplant recipients: post-hoc analysis of the FAVORIT trial. American Journal of Transplantation, 12(9), 2437-45. Carey, L.A., Rugo, H.S., Marcom, P.K., Mayer, E.L., Esteva, F.J., Ma, C.X., Liu, M.C., Storniolo, A.M., Rimawi, M.F., Forero-Torres, A., Wolff, A.C., Hobday, T.J., Ivanova, A., Chiu, W.K., Ferraro, M., Burrows, E., Bernard, P.S., Hoadley, K.A., Perou, C.M., Winer, E.P. (2012). TBCRC 001: randomized Phase II study of cetuximab in combination with carboplatin in stage IV triple negative breast cancer. Journal of Clinical Oncology, 30(21), 2615-23. PMID: 22665533 Rossi, E, Ivanova, A, Boggess, J.F. (2012). Robotically assisted fluorescence-guided lymph node mapping with ICG for gynecologic malignancies: a feasibility study. Gynecologic Oncology, 124, 78-82. Beaven, A, Shea, T., Moore, D., Feldman, Ivanova, A., Ferraro, M., Ford, Smith, Goy. (2012). A Phase I study evaluating Ibritumomab Tiuxetan (Zevalin) in combination with Bortezomib (Velcade) in relapsed/refractory mantle cell and low grade B cell Non Hodgkin Lymphoma. Leukemia and Lymphoma 53(2):254-258. Davies, J.M., Dhruva, N.S., Walko, C.M., Socinski, M.A., Bernard, S., Hayes, D.N., Kim, W.Y., Ivanova, A., Keller, K., Hilbun, L.R., Chiu, M., Dees, E.C., Stinchcombe, TE. (2011). A phase I trial of sorafenib combined with cisplatin/etoposide or carboplatin/pemetrexed in refractory solid tumor patients. Lung Cancer 71(2):151-5 PMID: 20580118 Sanoff H.K., Davies J., Walko, C., Buie L., Chiu, W.K., Ivanova A., O'Neil, B., Stinchcombe, T.E., Keller, K., Dees, E.C. (2011). A Phase I trial of Vinflunine and Premetrexed in refractory solid tumors. Investigational New Drugs 29(1):131-136. PMID: 19830387 Sanoff H.K., Davies J., Walko, C., Irvin, W., Buie L., Keller, K., Ivanova A., Chiu, W.K., O'Neil, B., Stinchcombe, T.E., Dees, E.C. (2011). A phase I evaluation of the combination of vinflunine and erlotinib in patients with refractory solid tumors. Investigational New Drugs 29(5):978-83. PMID: 20387090 Irvin, W.J., Orlowski, R.Z., Chiu, M., Carey, L.A., Collichio, F.A., Perou, C., Ivanova, A., Dees, E.C. (2010). Phase II Study of Bortezomib and Pegylated Liposomal Doxorubicin in the Treatment of Metastatic Breast Cancer. Clinical Breast Cancer 10(6):465-70.PMID: 21147690 ONeil, B.H., Raftery, L., Calvo, B.F., Chakravarthy, B.H., Ivanova, A., Myers, M.O., Kim, H.J., Chan, E., Wise, P.E., Caskey, L.S., Bernard, S.A., Sanoff, H.K., Goldberg, R.M., Tepper, J.E. (2010). A phase I Study of Bortezomib in Combination with Standard 5-fluorouracil and External Beam Radiotherapy for the Treatment of Locally Advanced or Metastatic Rectal Cancer. Clinical Colorectal Cancer, 9, 2, 119-125. PMID: 20378507 Singh, S.S., Mehedint, D.C., Ford, O.H., Jeyaraj, D.A., Pop, E.A., Maygarden, S.J., Ivanova, A., Chandrasekhar, R., Wilding, G.E., Mohler, JL. (2009). Comparison of ACINUS, Caspase-3 and TUNEL as Apoptotic Markers in Determination of Tumor Growth Rates of Clinically Localized Prostate Cancer using Image Analysis. The Prostate, 69,1603-1610. Knovich, M.A., Il'yasova, D., Ivanova, A., Molnar, I. (2008). The Association between Serum Copper and Anemia in the Adult NHANES II Population. British Journal of Nutrition, 99, 1226-1229. PMID: 18533287 Ilasova, D., Ivanova, A., Morrow, J.D., Cesari, M., Pahor, M. (2008). Correlation between two markers of inflammation, serum C-reactive protein (CRP) and interleukin-6 (IL-6) and indices of oxidative stress in patients with high risk of cardiovascular disease. Biomarkers 13, 41-51. PMID: 17852073 Dees, E.D., ONeil, B.H., Lindley, C.M., Collichio, F., Carey, L.A., Collins, J., Riordan, W.J., Ivanova, A, Esseltine, D., Orlowski, R.Z. (2008). A Phase I and Pharmacologic Study of the Combination of Bortezomib and Pegylated Liposomal Doxorubicin in Patients with Refractory Solid Tumors. Cancer Chemotherapy and Pharmacology, 63, 99-107. PMID: 18327587 Wlassoff, W.A., Sivashinski, M.S., Ivanova, A., Appelbaum, J.G., Salganik, R.I. (2007). Hydrogen peroxide overproduced in breast cancer cells can serve as anticancer prodrug stimulating hydroxyl radicals produced apoptosis under the effect of tamoxifen-ferrocene conjugate. Journal of Pharmacy and Pharmacology 59, 1549-1553. Stinchcombe, T.E., Socinski, M.A., Walko, C.M., ONeil, B.H., Collichio, F.A., Ivanova, A., Mu, H., Hawkins, M.J., Goldberg, R.M., Lindley, C., Dees, E.C.. (2007). Phase I and Pharmacokinetic Trial of Carboplatin and Albumin-bound Paclitaxel, ABI-007 (Abraxane() on Three Treatment Schedules in Patients with Solid Tumors. Cancer Chemotherapy and Pharmacology, 60 759-766. Kelly, H., Kimmick, G., Dees, E.C., Collichio, F., Gatti, L., Sawyer, L., Ivanova, A., Dressler, L., Graham, M.L., Carey, L.A.. (2006). Response and cardiac toxicity of trastuzumab given in conjunction with weekly paclitaxel after doxorubicin/cyclophosphamide. Clinical Breast Cancer 7(3): 237-243. Schroeder, J.C., Bensen, J.T., Su, J., Mishel, M., Ivanova, A., Smith, G., Godley, P., Fontham, E., Mohler, J.L.. (2006). The North Carolina-Louisiana Prostate Cancer Project (PCaP): Methods and design of a multidisciplinary population-based cohort study of racial differences in prostate cancer outcomes. The Prostate, 66, 11,1162-1176. Carson S.S., Kress, J.P., Rodgers, J.O., Vinayak, A., Campbell-Bright, S., Levitt, J., Bourdet, S., Ivanova, A., Henderson, A.G., Pohlman, A., Chang, L., Rich, P.B., Hall, J. (2006). A randomized trial of intermittent lorazepam versus propofol with daily interruption in mechanically ventilated patients. Critical Care Medicine, 34, 1326-1332. Socinski, M.A., Ivanova, A., Bakri, K., Wall, J., Baggstrom, M.Q., Hensing. T.A., Meras, A., Tynan, M., Beaumont, J., Peterman, A.H., Niell, H.B. (2006). A randomized phase II trial comparing every-3-week carboplatin/paclitaxel with every-3-week carboplatin and weekly paclitaxel in advanced non-small cell lung cancer, Annals of Oncology, 17, 104-109. Konrad, T.R., Howard, D.L., Edwards, L., Ivanova, A., Carey, T. (2005). Physician-patient racial concordance, continuity, and patterns of care for hypertension. American Journal of Public Health, 95, 2186-2190. Orlowski, R.Z., Voorhees, P.M., Garcia, R.A., Hall, M.D., Kudrik, F.J., Allred, T., Johri, A.R., Jones, P.E., Ivanova, A., Van Deventer, H.W., Gabriel, D.A., Shea, T.C., Mitchell, B.S., Adams, J., Esseltine, D., Trehu, E.G., Green, M., Lehman, M.J., Natoli, S., Collins, J.M., Lindley, C.M., Dees, E.C. (2005). Phase I Trial of the Proteasome inhibitor bortezomib and pegylated liposomal doxorubicin in patients with advanced hematologic malignancies, Blood, 105, 3058 - 3065. Il'yasova D., Morrow J.D., Ivanova A., Wagenknecht L.E. (2004). Epidemiological marker for oxidant status: comparison of the ELISA and the gas hromatography/mass spectrometry assay for urine 3-dinor-5,6-dihydro-15-F2t-isoprostane. Annals of Epidemiology, 14(10), 793-797. Peck, M.D., Kessler, M., Cairns, B.A., Chang, Y.H., Ivanova, A., Schooler, W. (2004). Early enteral nutrition does not decrease hypermetabolism associated with burn injury. Journal of Trauma, 57(6), 1143-1149. Schwartz G, Il'yasova D, Ivanova A. (2003). Urinary cadmium, impaired fasting glucose, and diabetes in the NHANES III. Diabetes Care, 26 (2), 468-470. Melki, S.A., Safar, A., Martin, J., Ivanova, A., Adi, M. (1999). Potential acuity pinhole: A simple method to measure potential visual acuity in patients with cataracts, comparison to PAM. Ophthalmology, 106, 7-14. Peer-Reviewed Book Chapters Ivanova, A., Oron, A. (2013). Up-and-down and escalation designs. In Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials and Design, Hoboken: John Wiley & Sons, Inc. Ivanova, A. (2008). Escalation and up-and-down designs. In Encyclopedia of Clinical Trials, Hoboken: John Wiley & Sons, Inc. Ivanova, A. (2008). Phase I trials in oncology. In Encyclopedia of Clinical Trials, Hoboken: John Wiley & Sons, Inc. Ivanova, A., Flournoy, N. (2008). Phase I clinical trials. Chapter 1 in Statistical Advances in the Biomedical Sciences: Clinical Trials, Epidemiology, Survival Analysis, and Bioinformatics (A. Biswas, S. Datta, J. Fine, M.Segal eds.). John Wiley, 3-15. Kuznetsova, O., Ivanova, A. (2007). Allocation in randomized clinical trials. Chapter 8 in Pharmaceutical Statistics usingSAS (C., DAgostino, R., Dmitrienko, A., eds), SAS Publishing, pp 213 - 235. Ivanova, A. (2006). Dose-finding in oncology - non-parametric methods. Chapter 4 in Dose Finding in Drug Development (N. Ting, ed.). Springer-Verlag, 49-58. Non Peer-Reviewed Publications Ivanova, A., Tamura, R. (2013). Letter to the Editor. Journal of Biopharmaceutical Statistics, 23, 709-710 Ivanova, A., Bunce, L. (2010). Design of Phase I trials. Chapter 11 in Fundamentals of Oncology Clinical Trials (K. Kelly, S. Halabi eds.). Demos Medical Publishing. Ivanova, A., Flournoy, N. (2006). Up-and-down designs in toxicity studies. Chapter 11 in Statistical Methods for Dose-Finding Experiments (S. Chevret, ed.). John Wiley, 115-130. Hu, F., Ivanova, A. (2004). Adaptive design. In Encyclopedia of Biopharmaceutical Statistics, 2nd edition, Marcel Dekker. Ivanova, A. (2002). On phase I trials design: Letter to the editor. Controlled Clinical Trials, 23, 182-183. Berger, V.W., Ivanova, A. (2001). Permutation tests for phase III clinical trials. Chapter 14 in S(PLUS in the Pharmaceutical Industry (Millard, S. Kruase, A., eds.), Springer-Verlag, 349-375. Manuscripts under review at a refereed journal Farnan, L., Ivanova, A., Peddada, S. Performance of the pool adjacent violators algorithm (PAVA) for correlated normally distributed. Submitted Farnan, L., Ivanova, A., Peddada, S. Testing of parameters under inequality constraints in linear mixed effects models. Submitted Ivanova, A., Hoberman, S. Second order urn designs. Submitted Song, G., Ivanova, A. Bayesian enrollment and stopping rules for managing toxicity requiring long follow-up in Phase II oncology trials. Submitted Song, G., Ivanova, A. Frequentist enrollment and stopping rules for managing toxicity requiring long follow-up in Phase II oncology trials. Submitted Ivanova, A., Deal, A. Two-stage design for phase II oncology trials with relaxed futility stopping. Submitted Barry, E.L., Mott, L.A., Rees, J.R., Melamed, M.L., Ivanova, A., Sandler, R.S., Ahnen, D.J., Bresalier, R.S., Summers, R.W., Bostick, R.M., Baron, J.A. Calcium supplementation increases blood creatinine levels in a randomized controlled trial. Submitted Carpenter, M., John, A., Weir, M., Smith, S., Hunsicker, L. Kasiske, B.L., Kusek, J. W., Bostom, A., Ivanova, A. Levey, A.S, Weiner, D.E. Level of blood pressure and the risk of cardiovascular disease and all-cause mortality in kidney transplant recipients: the FAVORIT trial. Submitted Wang, J.J., Ivanova, A. Dose finding with the sequential parallel comparison design. Submitted. Articles in Russian Ivanova, A. (1992). Stochastic stability of algorithms with discrete time. In The Monte Carlo Methods in Computational Mathematics, 6670. (In Russian) Ivanova, A. (1991). Stochastic stability of algorithms when solving partial differential equations with the Monte Carlo method. Publications of St. Petersburg State University. (In Russian) Ivanova, A., Sushkov, Y.A. (1990). Multistate systems with binarypolar functional elements. Computational Cybernetics, 25, 3842. (In Russian) Software http://cancer.unc.edu/biostatistics/program/ivanova/ Easy to use software for Phase II oncology trials, including continuous boundary for toxicity monitoring, Simons and Flemings two-stage designs, two-stage design with relaxed stopping for futility and two-stage design for ordinal outcomes. Presentations PRIVATE Invited PRIVATE Presentations (presented or coauthored) Ivanova, A. Treatment selection with the sequential parallel comparison design. Fourth International Workshop in Sequential Methodologies. Athens GA, July 2013. Ivanova, A. Adaptive dose-finding: from audiometry to sleep apnea. ICSA/ ISBS joint statistical conference. Bethesda MD, June 2013. Ivanova, A. Designs for trials with high placebo response. Society for Clinical Trials meeting. Boston MA, May 2013. Ivanova, A. Designs for trials with high placebo response. Department of Biostatistics, Johns Hopkins University. Baltimore MD, April 2013. Ivanova, A. Adaptive two-stage trials with multiple treatment arms. COMPASS Consortium meeting. Philadelphia PA, April 2013. Ivanova, A. Comparing strategies for trials with high placebo response. ENAR. Orlando FL, March 2013. Ivanova, A. Learning with a two-stage design with multiple arms: adaptive and manageable. DIA/Industry Workshop. Bethesda MD, October 2012. Ivanova, A. High placebo response, crossover, placebo lead-in and randomized discontinuation designs. NC TraCS Biostatistics Seminar Series for Clinical and Translational Science Investigators. UNC September 2012. Ivanova, A. Comparing designs for trials with high placebo response 2012 FDA/Industry Workshop. Washington DC, September 2012. Ivanova, A., Miller, E., Gallo, P. Recent Adaptive Designs in Phase 2 and Phase 3: Theory and Implementation Short course, 2012 FDA/Industry Workshop. Washington DC, September 2012. Ivanova, A. Comparing Strategies for Trials with High Placebo Response. Biopharmaceutical Section Web-based Training Series, August 2012. Ivanova, A. Sample size re-estimation in Phase III trials. Quintiles, Durham NC, July 2012. Ivanova, A. Beyond the 3+3 design: methods for Phase I and II oncology trials. Quintiles, Durham NC, May 2012. Tamura, R., Ivanova, A. A doubly enriched clinical trial design merging placebo lead-in and randomized withdrawal, ENAR, Washington DC April 2012. Ivanova, A. Adaptive Two-Stage Designs for Multi-Arm Trials. BASS XVIII, Savannah GA, November 2011. Ivanova, A. Adaptive dose-finding in first-in-man: case study. 2011 FDA/Industry Workshop. Washington DC, September 2011. Ivanova, A. Beyond the 3+3 design: novel methods for oncology trials. University of Alabama Comprehensive Cancer Center, Birmingham AL, June 2011. Ivanova, A. Adaptive designs for dose-finding trials. Duke University, December 17, 2010. Ivanova, A. Can we use the CRM in Phase 2 trials? GlaxoSmithKline, October 2010. Ivanova, A. The CRM: pros, cons and misconceptions. FDA, Silver Spring, MD, September 2010. Ivanova, A. Lymph node identification study: can we do better with optimal design? MODA9, Bertrino, Italy, June 2010. Ivanova, A. Adaptive Dose Finding. The 4th Annual Probability and Statistics Day. UMBC, Baltimore, MD April 24, 2010. Ivanova, A. Dose finding in phase 2 trials. UK Medical Research Council Workshop on Dose-Finding Methodology in Early Phase Clinical Trials. Reading, UK, March 2010. Ivanova, A. Innovative dose finding designs. 60th anniversary of the Department of Biostatistics, UNC Chapel Hill. Chapel Hill NC, October 2009. Liu, K., Ivanova, A., Snyder, E., Snavely, D. Entsuah, R. Case Study: An Adaptive Design that Uses a Utility Function toIdentify the Best Dose in a Crossover Setting. ASA Biopharmaceutical /FDA Industry Workshop, Washington DC, September 2009. Ivanova, A. Adaptive dose finding in non-life threatening diseases. JSM. Washington DC, August 2009. Ivanova, A. Design and estimation in dose-ranging studies6-th St Petersburg Workshop on Simulation, St. Petersburg, Russia, July 2009. Ivanova, A. Adaptive dose finding. The second International Workshop in Sequential Methodologies, Troyes, France, June 2009. Ivanova, A. Finding the dose with the best efficacy/tolerability profile. ENAR. San Antonio, TX, March 2009. Ivanova, A. An Adaptive Design for Identifying the Dose with the Best Efficacy/Tolerability Profile. Department of Statistics, George Masson University. Fairfax, VA, February 2009. Ivanova, A. Dose-finding adaptive trials. Society of Clinical Trials annual meeting. St. Louis, May 2008. Liu, K., Ivanova, A., Snyder, E., Snavely, D. A Three-Period Crossover Adaptive Dose Design. Third Annual Adaptive Designs for Clinical Development. London, United Kingdom, May 2008. Ivanova, A. Adaptive designs for dose-finding trials. Tutorial.. The 63rd annual Deming Conference on applied statistics. Atlantic City, December 2007. Ivanova, A. Dose-finding for umbrella dose-response. Merck Research Laboratories. Philadelphia, September 2007. Ivanova, A. Dose-finding designs for Phase II A studies. GlaxoSmithKline Biostatistics Annual Conference. Philadelphia, September 2007. Ivanova, A. Dose-finding based on t-statistic. Merck Research Laboratories. Rahway, September 2007. Ivanova, A. Investigation of up-and-down strategies for isotonic dose-finding. MODA8, Spain, June 2007. Ivanova, A. Adaptive designs for dose-selection trials. Merck Research Laboratories. Rahway, February 2007. Ivanova, A. Dose-finding in oncology. GlaxoSmithKline. Cary, May 2007. Ivanova, A. Adaptive dose selection trials. Adaptive Designs For Clinical Development Summit, Germany, March 2007. Ivanova, A. Unified approach to treatment assignment in dose-finding trials CBIs 1st Forum on Dose Finding Studies, Philadelphia, February 2007. Ivanova, A. Non-parametric dose-finding designs: recent developments and examples. GlaxoSmithKline Biostatistics Annual Conference. Cary, November 2006. Ivanova, A., Qaqish, B., and Schell, M. Continuous toxicity monitoring in phase I trials in oncology. Georgetown University, Washington DC, March 2006. Ivanova, A. Aspects of teaching Biostatistics. How to teach Epidemiology, Prevention and Biostatistics in an MPH program, Saint Petersburg State University, Saint Petersburg, Russia, May 2005. Ivanova, A. Dose-finding in life-threatening diseases: non-parametric methods. Designing and analyzing dose response clinical trials, Philadelphia, PA, November 2004. Ivanova, A. Analysis of primary and secondary outcomes in trials allowing stopping based on secondary outcomes. Understanding applying and not misusing statistical techniques, Gaithersburg, MD, October 2004. Ivanova, A., Qaqish, B., and Schell, M. Continuous toxicity monitoring in phase II trials in oncology. UMBC, Baltimore, MD, October 2004. Ivanova, A. Response-adaptive designs: ethics and efficiency of estimation. Workshop on Adaptive designs, Fields Institute, Toronto, September 2003. Berger, V., Zhou, J., Ivanova, A., and Tremmel, L. Exact adjustment for ordinal covariates in randomized trials using partial orderings. ENAR, Tampa, FL, March 2003. Coad, S., and Ivanova, A. Sequential adaptive urn designs with elimination for comparing several treatmentstc \l 1 "Presentations". Meeting on Response Adaptive Clinical Trials, Sandwich, UK, November 2002. Rosenberger W.F., Stallard, N., and Ivanova, A. Optimal adaptive designs for binary response trials. Department of Biostatistics, UCLA, January 2002. Rosenberger W.F., Stallard, N., and Ivanova, A. Optimal adaptive designs for binary response trials. Department of Statistics, University of California, Santa Barbara, February 2002. Barrier, R. and Ivanova, A. Selection bias in adaptive clinical trials. Joint Statistical Meeting, Atlanta, GA, August 2001. Berger, V. and Ivanova, A. An alternative to the complete randomized block procedure. Joint Statistical Meeting, Atlanta, GA, August 2001. Ivanova, A. Designing an epidemiologic study. HIV and AIDS Epidemiology Meeting. St. Petersburg, May 2001. Rosenberger W.F., Stallard, N., and Ivanova, A. Optimal adaptive designs for binary response trials. SmithKline Beecham, Philadelphia, PA March 2001. Rosenberger W.F., Stallard, N., and Ivanova, A. Optimal adaptive designs for binary response trials. Department of Statistics, University of South Carolina, November 2001. Rosenberger W.F., Stallard, N., and Ivanova, A. Optimal adaptive designs for binary response trials. The EMMES Corporation, Rockville, MD, November 2001. Ivanova, A. Drop-the-loser rule in medical trials. University of Maryland, Baltimore, MD, October 2000. Ivanova, A. and Berger, V.W. Adaptive tests for ordinal categorical data. NCI, Bethesda, MD, October 2000. Ivanova, A. Drop-the-loser rule in medical trials. University of Georgia, Athens, GA, March 2000. Ivanova, A. Drop-the-loser rule in medical trials. Columbia University, New York, NY, February 2000. Rosenberger W.F., Stallard, N., and Ivanova, A. Optimal adaptive designs for binary response trials. PhRMA/FDA Workshop, Washington DC, October 2000. Ivanova, A. Drop-the-loser rule in medical trials. UNC at Chapel Hill, Chapel Hill, NC, October 1999. Ivanova, A. and Berger, V.W. Adaptive tests for ordinal data. The 1999 CCF-CWRU-OSU Statistics Symposium, Cleveland, OH, May 1999. Berger, V.W. and Ivanova, A. The conditional ttest of stochastic order is biased and least stringent for the product multinomial distribution. International Chinese Statistical Association (ICSA) Meeting, New Brunswick, NJ, May 1997. Other PRIVATE Presentations (prior to 2006) Coad, S., and Ivanova, A. The use of triangular test with response-adaptive treatment allocation. 55th Session of the International Statistical Institute, Sydney, Australia, April 2005. Wang, K., and Ivanova, A. Bayesian designs for two-dimensional phase I trials. JSM, San Francisco, CA, August 2003. Ivanova, A. New approach to dose-finding studies. Infectious Diseases Conference, UNC at Chapel Hill, July 2003 (invited as CFAR development grant recipient). Wang, K., and Ivanova, A. Designs for phase I trials with two agents. ENAR, Tampa, FL, March 2003. Berger, V. and Ivanova, A. Enhancing allocation concealment through less restrictive Randomization Procedures. ENAR, Charlotte, NC, March 2001. Ivanova A. and Berger V.W. Adaptive tests for ordinal categorical data. Joint Statistical Meeting, Baltimore, MD, August 1999. Melki S.A., Safar, A., Martin J., Ivanova A. and Adi, M. Potential acuity pinhole: A simple method to measure potential visual acuity in patients with cataracts, comparison to PAM. Meeting of the American Academy of Ophthalmology, New Orleans, November 1998. Ivanova A. and Durham, S. A birth and death urn for randomized clinical trials. Joint Statistical Meeting, Dallas, TX, August 1998. Ivanova A. A birth and death urn for randomized clinical trials. St. Petersburg Workshop on Simulation, St. Petersburg, Russia, June 1998. Ivanova A. and Rosenberger W.F. A birth and death urn for randomized clinical trials. MidAtlantic Probability and Statistics Day, Baltimore, MD, October 1997. Ivanova A.V. and Rosenberger W.F. A birth and death urn for randomized clinical trials. Graduate Student Research Day, Baltimore, MD, April 1997. Ivanova A. Stability of algorithms when solving partial differential equations with the Monte Carlo method, MidAtlantic Probability and Statistics Day, Baltimore, MD, October 1996. Teaching Graduate Courses Taught Design and Analysis of Clinical Trials Fall 2007, 2008, 2009, 2010, 2012 (jointly with L. LaVange 2007-2010) Probability and Statistical Inference I Fall 2000, 2002, 2003, 2004, 2005, 2011 Nonparametric Statistics (Case Western Reserve) Spring 1999 PhD/DrPH Thesis Supervised, Ongoing Student Name Degree Short Title Steven Hoberman co-advisor PhD Sequential designs with delayed outcome (jointly with M Kosorok) Yunro Chung co-advisor PhD Order restricted inference with continuous (jointly with J Fine) covariate Yunfei Wang co-advisor DrPH Dose-finding with censored data (jointly with E Lange) PhD/DrPH and other Thesis Supervised, Completed Student Name Year Degree Short Title Graduated Gouchen Song 2013 DrPH Sequential designs with delayed outcome Krishna Chotneeru 2013 MPH Methods for high placebo response Jessie Wang 2013 MS Multi-arm trials when placebo response is high Benjamin Gellman 2011 BSURE Methods for triple-blind Phase I trials Laura Lapkauskaite 2011 PhD Order restricted estimation and testing with (jointly with S. Peddada) correlated data Changfu Xiao 2011 PhD Adaptive designs for Phase II trials Yufan Zhao 2007 MS Dose-finding for umbrella dose-response Se Hee Kim 2007 MS Optimal allocation to find PEAK dose Shenghua Mao 2006 MS Improving dose selection trials Yeounsung Chung 2005 MS Zoom-in designs for dose-finding Nathan Carter 2004 MS Escalation designs Kai Wang 2003 PhD Bayesian and frequentist adaptive strategies for two-dimensional phase I trials Robert Barrier 2002 MS Adjusting for selection bias Doctoral Dissertation Committee Member Student Name Year Department Graduated Emily Colby 2012 Biostatistics Michael Hussey 2012 Biostatistics Lily Wang 2004 Biostatistics Szu-Yun Leu 2003 Biostatistics Michael Klotsman 2003 Epidemiology Dora Ilyasova 2001 Epidemiology Service UNC Academic Committees Advisory Committee for Diversity Programs and Recruitment, school-wide committee, 2012 present BSURE program committee (chair) 2008 present Social committee 2008 present Examination committee, 2000 present Protocol Review Committee, Lineberger Cancer Center, University of North Carolina at Chapel Hill, 1999 present Search committee, Department of Biostatistics, 2001, 2011 Search committee, Lineberger Cancer Center, 2004, 2006, 2007, 2008, 2009, 2011, 2012. New MPH program at St. Petersburg State University, Russia (Fogarty), 2004 2005. Stochastic Processes Course Committee, Department of Statistics and the Department of Biostatistics, 1999 Data and Safety Monitoring Board Service Member, Data and Safety Monitoring Committee, Lineberger Cancer Center, University of North Carolina at Chapel Hill, 1999 present Member, Hematology Data and Safety Monitoring Board, National Institutes of Health, National Heart Lung and Blood Institute, 2007 present Member, Data and Safety Monitoring Committee, Applied Genetic Technologies Corporation, 2008 present Member, Data and Safety Monitoring Board, Ikaria Pharmaceuticals, 2009 2013 Member, Data and Safety Monitoring Board, PhotoThera, 2010 2012 Member, Data and Safety Monitoring Board, Salix, 2011 present Editorial Service Associate Editor, Statistics in Medicine, 2006 present Associate Editor, Biometrics, July 1, 2011 December 31, 2013 Guest Associate Editor for the special Gary Koch Festschrift Issue for Statistics in Biopharmaceutical Research, 2011 Other Service The academic advisor to Oncology subgroup under the Drug Information Association (DIA) Adaptive Designs Scientific Working Group, 2013 - present The academic advisor to Cytels Dose Finding Consortium, 2012 - present Ad Hoc Reviewer (selected list) Annals of Statistics; Applied Statistics; Biometrika; Biometrics; Biostatistics; Journal of the Royal Statistical Society B; Journal of the American Statistical Association; Journal of Biopharmaceutical Statistics; Journal of Clinical Oncology; Journal of Neuro-Oncology; Journal of Statistical Planning andInference; Statistics and Probability Letters; Statistics in Medicine.   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