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Alex Dmitrienko

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Vice President, Center for Statistics in Drug Development, Innovation Unit, Quintiles

Education

1998: Ph.D., Statistics, University of Kentucky, Lexington, KY

1995: Ph.D., Applied Mathematics, Tomsk University, Tomsk, Russia

Honors

2009: Fellow of the American Statistical Association

2008: 2008 Thomas W. Teal Award for Excellence in Statistics Publishing (Drug Information Association)

2006: 2006 Donald E. Francke Award for Overall Excellence (Drug Information Association)

2005: Excellence in Continuing Education Award, American Statistical Association

Professional services

2008-Present: Executive Committee, Biopharmaceutical Section, American Statistical Association

2007-2009: Chair of Distance Training, Biopharmaceutical Section, American Statistical Association

2005-2008: Associated Editor, The American Statistician

2005-2009: Associated Editor, Encyclopedia of Clinical Trials, Wiley

2005-Present: Associated Editor, Statistics in Medicine

2007-Present: PhRMA/PISC Adaptive Design Working Group

2005-Present: PhRMA/PISC Adaptive Dose-Ranging Studies Expert Team

2002-2006: PhRMA Statistical QT Expert Team

2002-2005: PhRMA Multiple Endpoints Expert Team

2011-Present: Associated Editor, Biometrics

Papers

1. Dmitrienko, A., Konev, V.V. (1994). On guaranteed estimation of autoregressive parameters for an unknown variance of the noise. Automation and Remote Control. 55, 218-228.

2. Dmitrienko, A., Konev, V.V. (1994). On classification of multivariate autoregressive processes with unknown noise covariance properties. Journal of Communication Technology and Electronics. 39, 35-41.

3. Dmitrienko, A., Konev, V.V. (1995). On sequential classification of autoregressive processes with unknown variance of noise. Problems of Information Transmission. 31, 337-347.

4. Dmitrienko, A., Vexler, A.A. (1996). Renewal theory results for autoregressive processes. Mathematical Methods of Statistics. 5, 477-490.

5. Dmitrienko, A., Konev, V.V., Pergamenschikov, S.M. (1997). Sequential generalized least squares estimator of an autoregressive parameter. Sequential Analysis. 16, 25-46.

6. Dmitrienko, A., Govindarajulu, Z. (1997). On the “Demon” problem of Youden. Statistics and Probability Letters. 35, 65-72.

7. Dmitrienko, A., Govindarajulu, Z. (1998). The “Demon” problem of Youden: exponential case. Journal of Applied Statistics. 25, 517-523.

8. Dmitrienko, A., Govindarajulu, Z. (1998). Sequential estimation of a tail probability of an unknown distribution. Sequential Analysis. 17, 253-265.

9. Vexler, A.A., Dmitrienko, A. (1999). Approximations to expected stopping times with applications to sequential estimation. Sequential Analysis. 18, 165-187.

10. Fleming, S.T., Rastogi, A., Dmitrienko, A., Johnson, K.D. (1999). A comprehensive prognostic index to predict survival based on multiple comorbidities: a focus on breast cancer. Medical Care. 37, 601-614.

11. Dmitrienko, A., Govindarajulu, Z. (2000). Sequential confidence regions for maximum likelihood estimates. Annals of Statistics. 28, 1472-1501.

12. Dmitrienko, A., Govindarajulu, Z. (2002). On sequential estimation of the variance of an unknown distribution. Journal of Statistical Planning and Inference. 100, 221-237.

13. Dmitrienko, A., Govindarajulu, Z. (2002). The bootstrap point estimation: sequential approach. Journal of Statistical Planning and Inference. 100, 349-363.

14. Dmitrienko, A., Smith B. (2002). Analysis of QT interval in clinical trials. Drug Information Journal. 36, 269-279.

15. Abraham, E., Naum, C., Wunderink, R., Schein, R., Macias, W., Skerjanec, S., Dmitrienko, A., Farid, N., Forgue, T., Jiang, F. (2003). Efficacy and Safety of LY315920Na/S-5920, a selective inhibitor of 14-kda group IIa PLA2 in patients with suspected sepsis and Organ Failure. Critical Care Medicine 31, 718-728.

16. Dmitrienko, A., Smith, B. (2003). Repeated-measures models in the analysis of QT interval. Pharmaceutical Statistics 2, 175-190.

17. Dmitrienko, A., Offen, W., Westfall, P.H. (2003). Gatekeeping strategies for clinical trials that do not require all primary effects to be significant. Statistics in Medicine. 22, 2387-2400.

18. Dmitrienko, A. (2003). Modeling paired categorical outcomes in clinical trials. Pharmaceutical Statistics 2, 279-289.

19. Dmitrienko, A. (2003). Covariate-adjusted reference intervals for diagnostic data. Journal of Biopharmaceutical Statistics 13, 191-208.

20. Zeiher, B.G., Artigas, A., Vincent, J.L., Dmitrienko, A., Jackson, K., Thompson, B.T., Bernard, G. (2004). Neutrophil elastase inhibition in acute lung injury: Results of the STRIVE study. Critical Care Medicine 32, 1695-1702.

21. Wiens, B.L., Dmitrienko, A., Westfall, P.H. (2004). Fallback and gatekeeping strategies for primary and secondary endpoints. American Statistical Association Biopharmaceutical Section Proceedings.

22. Bowton, D.L., Dmitrienko, A., Israel, E., Zeiher, B.G., Sides, G.D. (2005). Impact of an sPLA2-IIA inhibitor on inhaled allergen challenge in subjects with asthma. Journal of Asthma 41, 65-71.

23. Bradley, J.D., Dmitrienko, A.A., Kivitz, A.J., Gluck, O.S., Weaver, A.L., Wiesenhutter, C., Myers, S.L., Sides, G.D. (2005). A randomized, double-blinded, placebo-controlled clinical trial of LY333013, a selective inhibitor of group II secretory phospholipase A2, in the treatment of rheumatoid arthritis. Journal of Rheumatology. 32, 417-423.

24. Beasley, C.M. Jr, Mitchell, M.I., Dmitrienko, A.A., Emmick, J.T., Shen, W., Costigan, T.M., Bedding, A.W., Turik, M.A., Bakhtyari, A., Warner, M.R., Ruskin, J.N., Cantilena, L.R. Jr, Kloner, R.A. (2005). The combined use of ibutilide as an active control with intensive ECG sampling and signal averaging as a sensitive method to assess the effects of tadalafil on the human QT interval. Journal of American College of Cardiology. 46, 678-687.

25. Wiens, B.L., Dmitrienko, A. (2005). The fallback procedure for evaluating a single family of hypotheses. Journal of Biopharmaceutical Statistics. 15, 929-942.

26. Dmitrienko, A., Govindarajulu, Z. (2005). Sequential estimation in binary response models with fixed and random covariates. Sequential Analysis. 24, 219-236.

27. Patterson, S., Agin, M., Anziano, R., Burgess, T., Chuang-Stein, C., Dmitrienko, A., Ferber, G., Geraldes, M., Ghosh, K., Menton, R., Natarajan, J., Offen, W., Saoud, J., Smith, B., Suresh, R., Zariffa, N. (2005). Investigating drug-induced QT and QTc prolongation in the clinic: A review of statistical design and analysis considerations. Drug Information Journal. 39, 243-266.This paper received the 2006 Donald E. Francke Award for Overall Excellence (Drug Information Association).

28. Dmitrienko, A., Sides, G., Winters, K., Kovacs, R., Eisenberg, P., Groh, W. (2005). Electrocardiogram reference ranges derived from a standardized clinical trial population. Drug Information Journal. 39, 395-406.

29. Dmitrienko, A., Hsu, J. (2005). Multiple testing in clinical trials. Encyclopedia of Statistical Sciences. Second Edition. N. Balakrishnan (editor), Wiley.

30. Dmitrienko, A., Offen, W., Wang, O., Xiao, D. (2006). Gatekeeping procedures in dose-response clinical trials based on the Dunnett test. Pharmaceutical Statistics. 5, 19-28.

31. Dmitrienko, A., Wang, M.D. (2006). Bayesian predictive approach to interim monitoring in clinical trials. Statistics in Medicine. 25, 2178-2195.

32. Dmitrienko, A., Wiens, B.L., Westfall, P.H. (2006). Fallback tests in dose-response clinical trials. Journal of Biopharmaceutical Statistics. 16, 745-755.

33. Dmitrienko, A., Tamhane, A.C., Wang, X., Chen, X. (2006). Stepwise gatekeeping procedures in clinical trial applications. Biometrical Journal. 48, 984-991.

34. Offen, W., Chuang-Stein, C., Dmitrienko, A., Littman, G., Maca, J., Meyerson, L., Muirhead, R., Stryszak, P., Boddy, A., Chen, K., Copley-Merriman, K., Dere, W., Givens, S., Hall, D., Henry, D., Jackson J.D., Krishen, A., Liu, T., Ryder, S., Sankoh, A.J., Wang, J., Yeh, C.H. (2007). Multiple co-primary endpoints: Medical and statistical solutions. A report from the Multiple Endpoints Expert Team of the Pharmaceutical Research and Manufacturers of America. Drug Information Journal. 41, 31-46. This paper received the 2008 Thomas W. Teal Award for Excellence in Statistics Publishing (Drug Information Association).

35. Dmitrienko, A., Fritsch, K., Hsu, J., Ruberg, S. (2007). Design and analysis of dose-ranging clinical studies. Pharmaceutical Statistics Using SAS: A Practical Guide. Dmitrienko, A., Chuang-Stein, C., D’Agostino, R. (editors). SAS Press: Cary, NC.

36. Chuang-Stein, C., Stryszak, P., Dmitrienko, A., Offen, W. (2007). Challenge of multiple co-primary endpoints: A new approach. Statistics in Medicine. 26, 1181-1192.

37. Dmitrienko, A., Wiens, B.L., Tamhane, A.C., Wang, X. (2007). Tree-structured gatekeeping tests in clinical trials with hierarchically ordered multiple objectives. Statistics in Medicine. 26, 2465-2478.

38. Beyerbach, D.M., Kovacs, R.J., Dmitrienko, A.A., Rebhun, D.M., Zipes, D.P. (2007). Heart rate corrected QT interval in men increases during winter months. Heart Rhythm. 4, 277-281.

39. Agnelli, G., Haas, H., Ginsberg, J.S., Krueger, K.A., Dmitrienko, A., Brandt, J.T. (2007). A Phase II study of the oral Factor Aa inhibitor LY517717 for the prevention of venous thromboembolism after hip or knee replacement. Journal of Thrombosis and Haemostasis. 5, 746-753.

40. Dmitrienko, A., Tamhane, A.C. (2007). Gatekeeping procedures with clinical trial applications. Pharmaceutical Statistics. 6, 171-180.

41. Dmitrienko, A., Tamhane, A., Wiens, B. (2007). General multistage gatekeeping procedures. Northwestern University. Department of Industrial Engineering and Management Sciences. Working Paper No. 07-06. Available at http://www.iems.northwestern.edu/research/papers.html.

42. Bornkamp, B., Bretz, F., Dmitrienko, A., Enas, G., Gaydos, B., Hsu, C.-H., König, F., Krams, M., Liu, Q., Neuenschwander, B., Parke, T., Pinheiro, J., Roy, A., Sax, R., Shen, F. (2007). Innovative approaches for designing and analyzing adaptive dose-ranging trials. Journal of Biopharmaceutical Statistics. 17, 965-995.

43. Ma, H., Smith, B., Dmitrienko, A. (2008). Statistical analysis methods for QT/QTc prolongation. Journal of Biopharmaceutical Statistics. 18, 553-563.

44. Zhang, L., Dmitrienko, A., Luta, G. (2008). Sample size calculations in thorough QT studies. Journal of Biopharmaceutical Statistics. 18, 468-482.

45. Dmitrienko, A., Tamhane, A., Wiens, B. (2008). General multistage gatekeeping procedures. Biometrical Journal. 50, 667-677. See Dmitrienko Tamhane Wiens 2008.

46. Dmitrienko, A., Tamhane, A., Liu, L., Wiens, B. (2008). A note on tree gatekeeping procedures in clinical trials. Statistics in Medicine. 27, 3446-3451. See Dmitrienko Tamhane Liu Wiens 2008.

47. Beasley, C.M., Dmitrienko, A., Mitchell, M.I. (2008). Design and analysis considerations for thorough QT studies employing conventional ECG recordings. Expert Review of Clinical Pharmacology. 1, 815-839.

48. Dmitrienko, A., Tamhane, A., Liu, L. (2008). Mixtures of multiple testing procedures with gatekeeping applications. Northwestern University. Department of Industrial Engineering and Management Sciences. Working Paper 08-04. Available at http://www.iems.northwestern.edu/research/papers.html.

49. Chuang-Stein, C., Dmitrienko, A., Offen, W. (2009). Discussion of "Some controversial multiple testing problems in regulatory applications" by H.M. James Hung and Sue-Jane Wang. Journal of Biopharmaceutical Statistics. 19, 14-21.

50. Dmitrienko, A., Bretz, F., Westfall, P.H., Troendle, J., Wiens, B.L., Tamhane, A.C., Hsu, J.C. (2009). Multiple testing methodology. Multiple Testing Problems in Pharmaceutical Statistics. Dmitrienko, A., Tamhane, A.C., Bretz, F. (editors). Chapman and Hall/CRC Press, New York.

51. Tamhane, A.C., Dmitrienko, A. (2009). Analysis of multiple endpoints in clinical trials. Multiple Testing Problems in Pharmaceutical Statistics. Dmitrienko, A., Tamhane, A.C., Bretz, F. (editors). Chapman and Hall/CRC Press, New York.

52. Dmitrienko, A., Tamhane, A.C. (2009). Gatekeeping procedures in clinical trials. Multiple Testing Problems in Pharmaceutical Statistics. Dmitrienko, A., Tamhane, A.C., Bretz, F. (editors). Chapman and Hall/CRC Press, New York.

53. Wiens, B., Dmitrienko, A. (2010). On selecting a multiple comparison procedure for analysis of a clinical trial: Fallback, fixed-sequence and related procedures. Statistics in Biopharmaceutical Research. 2, 22-32.

54. Zhao, Y.D., Dmitrienko, A., Tamura, R. (2010). Design and analysis considerations in clinical trials with a sensitive subpopulation. Statistics in Biopharmaceutical Research. 2, 72-83.

55. Chiang, A., Mallinckrodt, C.H., Dmitrienko, A., Leishman, D.J. (2010). Utility of positive controls in assessing assay sensitivity in ICH S7B and ICH E14 guidance documents. Journal of Pharmacological and Toxicological Methods. 62, 143-147.

56. Dmitrienko, A., Tamhane, A.C. (2011). Mixtures of multiple testing procedures for gatekeeping applications in clinical trials. Statistics in Medicine. 30, 1473-1488. See Dmitrienko Tamhane 2011.

57. Millen, B.A., Dmitrienko, A. (2011). Chain procedures: A class of flexible closed testing procedures with clinical trial applications. Statistics in Biopharmaceutical Research. 3, 14-30. See Millen Dmitrienko 2011.

58. Dmitrienko, A., Kordzakhia, G., Tamhane, A.C. (2011). Multistage and mixture parallel gatekeeping procedures in clinical trials. Journal of Biopharmaceutical Statistics. 21, 726-747. See Dmitrienko Kordzakhia Tamhane 2011.

59. Brechenmacher, T., Xu, J., Dmitrienko, A., Tamhane, A.C. (2011). A mixture gatekeeping procedure based on the Hommel test for clinical trial applications. Journal of Biopharmaceutical Statistics. 21, 748-767. See Brechenmacher Xu Dmitrienko Tamhane 2011.

60. Dmitrienko, A., Soulakova, J.N., Millen, B.A. (2011). Three methods for constructing parallel gatekeeping procedures in clinical trials. Journal of Biopharmaceutical Statistics. 21, 768-786. See Dmitrienko Soulakova Millen 2011.

61. Lipkovich, I., Dmitrienko, A., Denne, J., Enas, G. (2011). Subgroup identification based on differential effect search (SIDES): A recursive partitioning method for establishing response to treatment in patient subpopulations. Statistics in Medicine. 30, 2601-2621.

62. Dmitrienko, A., Millen, B.A., Brechenmacher, T., Paux, G. (2011). Development of gatekeeping strategies in confirmatory clinical trials. Biometrical Journal. 53, 875-893. See Dmitrienko Millen Brechenmacher Paux 2011.

63. Qu, Y., Liu, R., Dmitrienko, A., Offen, W. (2011). A new classification approach for comparing two active treatments when there is no prior projection on which one is better. Statistics in Medicine. 30, 3488-3495.

64. Millen, B., Dmitrienko, A., Ruberg, S., Shen, L. (2012). A statistical framework for decision making in confirmatory multipopulation tailoring clinical trials. Drug Information Journal. 46, 647-656.

65. Kordzakhia, G., Dmitrienko, A. (2013). Superchain procedures in clinical trials with multiple objectives. Statistics in Medicine. 32, 486-508. See Kordzakhia Dmitrienko 2013.

66. Dmitrienko, A., D'Agostino, R.B., Huque, M.F. (2013). Key multiplicity issues in clinical drug development. Statistics in Medicine. 32, 1079–1111.

67. Dmitrienko, A., Tamhane, A.C. (2013). General theory of mixture procedures for gatekeeping. Biometrical Journal. 55, 402-419. See Dmitrienko Tamhane 2013.

68. Huque, M.F., Dmitrienko, A., D'Agostino, R.B. (2013). Multiplicity issues in clinical trials with multiple objectives. Statistics in Biopharmaceutical Research. 5, 321-337. See Huque Dmitrienko DAgostino 2013.

69. Wang, S.J., Bretz, F., Dmitrienko, A., Hsu, J., Hung, J., Huque, M., Koch, G. (2013). Panel forum on multiple comparison procedures: a commentary from a complex trial design and analysis plan. Biometrical Journal. 55, 275-293.

70. Wiens, B., Dmitrienko, A., Marchenko, O. (2013). Selection of hypothesis weights and ordering when testing multiple hypotheses in clinical trials. Journal of Biopharmaceutical Statistics. 23, 1403-1419.

71. Dmitrienko, A., D'Agostino, R.B. (2013). Tutorial in Biostatistics: Traditional Multiplicity Adjustment Methods in Clinical Trials. Statistics in Medicine. 32, 5172-5218.

72. Lipkovich, I., Dmitrienko, A. (2014). Strategies for identifying predictive biomarkers and subgroups with enhanced treatment effect in clinical trials using SIDES. Journal of Biopharmaceutical Statistics. 24, 130-153. See Lipkovich Dmitrienko 2014b.

73. Dmitrienko, A., Millen, B., Lipkovich, I. (2014). Statistical and regulatory considerations in subgroup analysis. Statistics in Medicine.

74. Ghebretinsae, A.H., Molenberghs, G., Dmitrienko, A., Offen, W., Sethuraman, G. (2014). Assessment of Type I error rate associated with dose group switching in a longitudinal Alzheimer trial. Journal of Biopharmaceutical Statistics. 24, 660-684.

75. Millen, B., Dmitrienko, A., Song, G. (2014). Bayesian assessment of the influence and interaction conditions in multi-population tailoring clinical trials. Journal of Biopharmaceutical Statistics. 24, 94-109.

76. Millen, B., Dmitrienko, A., Mandrekar, S., Zhang, Z., Williams, D. (2014). Analysis considerations in multi-population tailoring clinical trials. Therapeutic Innovation and Regulatory Science.

77. Lipkovich, I., Dmitrienko, A. (2014). Biomarker identification in clinical trials. Clinical and Statistical Considerations in Personalized Medicine. Carini, C., Menon, S., Chang, M. (editors). Chapman and Hall/CRC Press, New York. See Lipkovich Dmitrienko 2014.

Books

1. Dmitrienko, A., Molenberghs, G., Chuang-Stein, C., Offen, W. (2005). Analysis of Clinical Trials Using SAS. SAS Press: Cary, NC.

2. Dmitrienko, A., Chuang-Stein, C., D'Agostino, R. (editors) (2007). Pharmaceutical Statistics Using SAS. SAS Press: Cary, NC.

3. Dmitrienko, A., Tamhane, A.C., Bretz, F. (editors). (2009). Multiple Testing Problems in Pharmaceutical Statistics. Chapman and Hall/CRC Press, New York.

Short courses

1. Concepts used in clinical trials (distance education course). Pharmaceutical Education and Research Institute. 2001-Present.

2. Analysis of clinical trials: Theory and applications (full-day course). Joint Statistical Meetings, Minneapolis, MN. August 2005 [Excellence in Continuing Education Award, American Statistical Association].

3. Multiple comparisons and multiple endpoints in clinical trials and Interim data monitoring in clinical trials (full-day course). Quintiles, Kansas City, MO. October 2005.

4. Multiple comparisons and multiple endpoints in clinical trials (half-day course). Deming conference, Atlantic City, NJ. December 2005.

5. Multiple comparisons and multiple endpoints in clinical trials, Interim data monitoring in clinical trials (full-day course). San Diego ASA chapter, San Diego, CA. January 2006.

6. Analysis of clinical trials: Theory and applications (full-day course). Joint Statistical Meetings, Seattle, WA. August 2006.

7. Multiple comparisons and multiple endpoints in clinical trials (web-based course). Biopharmaceutical Section, American Statistical Association. March 2007.

8. Multiple comparisons in clinical trials (half-day course). American Statistical Association LearnStat series, Princeton, NJ. March 2007.

9. Analysis of multiple endpoints in clinical trials (half-day course). International Multiple Comparison conference, Vienna, Austria. July 2007.

10. Analysis of clinical trials: Theory and applications (full-day course). Joint Statistical Meetings, Salt Lake City, UT. August 2007.

11. Cardiac safety in clinical trials (web-based course). Biopharmaceutical Section, American Statistical Association. May 2008.

12. Analysis of clinical trials: Theory and applications (full-day course). Joint Statistical Meetings, Denver. August 2008.

13. Multiple comparisons and multiple endpoints in clinical trials (half-day course). FDA/Industry Statistics Workshop, Washington, DC. September 2008.

14. Multiple comparisons in clinical trials (full-day course). Food and Drug Administration, Washington, DC. October 2008.

15. Multiple endpoints in clinical trials (full-day course). International Multiple Comparison conference, Tokyo, Japan. March 2009.

16. Analysis of clinical trials: Theory and applications (full-day course). Joint Statistical Meetings, Washington, DC. August 2009.

17. Key Multiplicity Issues in Clinical Trials 2010 (full-day course). Indiana ASA chapter meeting, Indianapolis, IN. April 2010.

18. Multiple Testing Problems in Clinical Trials 2010 (full-day course). Osaka University, Osaka, Japan. July 2010.

19. Analysis of clinical trials: Theory and applications (full-day course). Joint Statistical Meetings, Vancouver, British Columbia. August 2010.

20. Multiplicity Issues in Clinical Trials 2010 (full-day course). Paris, France. October 2010.

21. Gatekeeping Procedures in Clinical Trials 2010 (half-day course). Deming conference, Atlantic City, NJ. December 2010.

22. Key Multiplicity Issues in Clinical Trials 2011 (full-day course). Applied Statistics Workshop, Los Angeles, CA. April 2011.

23. Analysis of clinical trials: Theory and applications (full-day course). Joint Statistical Meetings, Miami, FL. August 2011.

24. Gatekeeping Procedures in Clinical Trials 2011 (half-day course). International Conference on Multiple Comparison Procedures, Washington, DC. August 2011.

25. Key Multiplicity Problems in Clinical Trials 2011 (half-day course). FDA/Industry Statistics Workshop, Washington, DC. September 2011.

26. Multiplicity Issues in Clinical Trials 2012 (half-day course). FDA/DIA Statistics Forum, Washington, DC. April 2012.

27. Analysis of clinical trials: Theory and applications (full-day course). Joint Statistical Meetings, San Diego, CA. July 2012.

28. Multiplicity Issues in Clinical Trials 2013 (half-day course). ENAR conference, Orlando, FL. March 2013.

29. Analysis of clinical trials: Theory and applications (full-day course). Joint Statistical Meetings, Montreal, Canada. August 2013.

30. Multiple Testing Problems in Clinical Trials 2013 (two-day course). IBS German Region meeting, Berlin, September 2013.