Stephen George, PhD

Department:
Biostatistics and Bioinformatics

Email Address:
stephen.george@duke.edu

Address:
DUMC Box 2717

Durham, NC 27710

Telephone:
9196812224

Fax Telephone:
9196689335

Research Interests:
Statistical issues related to the design, conduct, and analysis of clinical trials and related biomedical studies including sample size and study length determinations, sequential procedures, and the analysis of prognostic or predictive factors in clinical trials.

Publications:
2007 -- Pubmed # 17227987 -- George SL. Response rate as an endpoint in clinical trials. J Natl Cancer Inst. 2007 Jan 17;99(2):98-9.

2007 -- Jung, S. H. and George, S. L. Between-arm comparison as a supplementary analysis of randomized phase II trials. Journal of Biopharmaceutical Statistics, 2007 (in press).

2006 -- Pubmed # 17008694 -- Dilts DM, Sandler AB, Baker M, Cheng SK, George SL, Karas KS, McGuire S, Menon GS, Reusch J, Sawyer D, Scoggins M, Wu A, Zhou K, Schilsky RL, . Processes to activate phase III clinical trials in a Cooperative Oncology Group: the Case of Cancer and Leukemia Group B. J Clin Oncol. 2006 Oct 1;24(28):4553-7.

2006 -- George, S.L., Green, M.R.:  Controversies in the early reporting of a clinical trial in early breast cancer, in Demets, D.L., Furburg, C. , Friedman, L., (eds):  Data Monitoring in Clinical Trials: A Case Studies Approach, Springer, New York, 346-359, 2006.

2006 -- Pubmed # 17146978 -- Jung SH, Owzar K, George SL, Lee T. P-value calculation for multistage phase II cancer clinical trials. J Biopharm Stat. 2006;16(6):765-75; discussion 777-83.

2005 -- Pubmed # 16279354 -- Bang H, Jung SH, George SL. Sample size calculation for simulation-based multiple-testing procedures. J Biopharm Stat. 2005;15(6):957-67.

2005 -- Pubmed # 16189805 -- Jung SH, Owzar K, George SL. A multiple testing procedure to associate gene expression levels with survival. Stat Med. 2005 Oct 30;24(20):3077-88.

2005 -- Jung, S.H., Owzar, K., and George, S.L.  Associating microarray data with a survival endpoint. In  Shoemaker, J.S., Lin, S.M. (eds):  Methods of Microarray Data Analysis IV, New York, 2005, pp 109-120.

2005 -- Pubmed # 15572587 -- Moore JO, George SL, Dodge RK, Amrein PC, Powell BL, Kolitz JE, Baer MR, Davey FR, Bloomfield CD, Larson RA, Schiffer CA. Sequential multiagent chemotherapy is not superior to high-dose cytarabine alone as postremission intensification therapy for acute myeloid leukemia in adults under 60 years of age: Cancer and Leukemia Group B Study 9222. Blood. 2005 May 1;105(9):3420-7.

2005 -- Pubmed # 16422312 -- Moser BK, George SL. A general formulation for a one-sided group sequential design. Clin Trials. 2005;2(6):519-28.

2005 -- Schiffer CA, George SL: Haematologic malignancies: Challenges in developing new therapeutic approaches, in Day SJ, Machin D, Green SB (eds): Textbook of Clinical Trials (2nd ed), New York, 2005.

2004 -- Pubmed # 15122727 -- Ellenberg SS, George SL. Should statisticians reporting to data monitoring committees be independent of the trial sponsor and leadership? Stat Med. 2004 May 30;23(10):1503-5.

2004 -- Pubmed # 15316949 -- George SL, Freidlin B, Korn EL. Strength of accumulating evidence and data monitoring committee decision making. Stat Med. 2004 Sep 15;23(17):2659-72.

2004 -- Pubmed # 15163611 -- Joffe S, Harrington DP, George SL, Emanuel EJ, Budzinski LA, Weeks JC. Satisfaction of the uncertainty principle in cancer clinical trials: retrospective cohort analysis. BMJ. 2004 Jun 19;328(7454):1463.

2004 -- Pubmed # 14755389 -- Jung SH, Lee T, Kim K, George SL. Admissible two-stage designs for phase II cancer clinical trials. Stat Med. 2004 Feb 28;23(4):561-9.

2004 -- Pubmed # 15514371 -- Kolitz JE, George SL, Dodge RK, Hurd DD, Powell BL, Allen SL, Velez-Garcia E, Moore JO, Shea TC, Hoke E, Caligiuri MA, Vardiman JW, Bloomfield CD, Larson RA, . Dose escalation studies of cytarabine, daunorubicin, and etoposide with and without multidrug resistance modulation with PSC-833 in untreated adults with acute myeloid leukemia younger than 60 years: final induction results of Cancer and Leukemia Group B Study 9621. J Clin Oncol. 2004 Nov 1;22(21):4290-301.

2004 -- Pubmed # 14980749 -- Korn EL, Freidlin B, George SL. Data monitoring and large apparent treatment effects. Control Clin Trials. 2004 Feb;25(1):67-9; author reply 71-2.

2003 -- Pubmed # 13130101 -- George SL. Selection bias, phase II trials, and the FDA accelerated approval process. J Natl Cancer Inst. 2003 Sep 17;95(18):1351-2.

2002 -- Pubmed # 12149202 -- Baer MR, George SL, Dodge RK, O'Loughlin KL, Minderman H, Caligiuri MA, Anastasi J, Powell BL, Kolitz JE, Schiffer CA, Bloomfield CD, Larson RA. Phase 3 study of the multidrug resistance modulator PSC-833 in previously untreated patients 60 years of age and older with acute myeloid leukemia: Cancer and Leukemia Group B Study 9720. Blood. 2002 Aug 15;100(4):1224-32.

2002 -- Pubmed # 12231521 -- Farag SS, George SL, Lee EJ, Baer M, Dodge RK, Becknell B, Fehniger T, Silverman LR, Crawford J, Bloomfield CD, Larson RA, Schiffer CA, Caligiuri MA. Postremission Therapy with Low-dose Interleukin 2 with or without Intermediate Pulse Dose Interleukin 2 Therapy Is Well Tolerated in Elderly Patients with Acute Myeloid Leukemia: Cancer and Leukemia Group B Study 9420. Clin Cancer Res. 2002 Sep;8(9):2812-9.

2002 -- Pubmed # 12216097 -- Gamel JW, George SL, Edwards MJ, Seigler HF. The long-term clinical course of patients with cutaneous melanoma. Cancer. 2002 Sep 15;95(6):1286-93.

2001 -- Pubmed # 11301391 -- Halperin EC, Watson DM, George SL. Duration of symptoms prior to diagnosis is related inversely to presenting disease stage in children with medulloblastoma. Cancer. 2001 Apr 15;91(8):1444-50.

2001 -- Pubmed # 11169597 -- Potthoff RF, Peterson BL, George SL. Detecting treatment-by-centre interaction in multi-centre clinical trials. Stat Med. 2001 Jan 30;20(2):193-213.

2000 -- Pubmed # 11018560 -- Ranstam J, Buyse M, George SL, Evans S, Geller NL, Scherrer B, Lesaffre E, Murray G, Edler L, Hutton JL, Colton T, Lachenbruch P. Fraud in medical research: an international survey of biostatisticians. ISCB Subcommittee on Fraud. Control Clin Trials. 2000 Oct;21(5):415-27.

1999 -- Pubmed # 10611617 -- Buyse M, George SL, Evans S, Geller NL, Ranstam J, Scherrer B, Lesaffre E, Murray G, Edler L, Hutton J, Colton T, Lachenbruch P, Verma BL. The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials. Stat Med. 1999 Dec 30;18(24):3435-51.

1999 -- Pubmed # 10503800 -- Freidlin B, Korn EL, George SL. Data monitoring committees and interim monitoring guidelines. Control Clin Trials. 1999 Oct;20(5):395-407.

1999 -- George,S.L. Early developmental clinical trials. In: ASCO Education Book, edited by Perry,M.C. Alexandria,VA: American Society of Clinical Oncolgy, 1999, p. 112-114.

1999 -- George,S.L. Multiple treatment trials. In: Handbook of Statistics in Clinical Oncology, edited by Crowley,J. New York: Marcel Dekker, 1999.

1999 -- George,S.L. Surrogate endpoints in cancer clinical trials. In: Statistical Models in Epidemiology, the Environment and Clinical Trials, edited by Halloran,M.E. and Berry,D.A. New York: Springer-Verlag, 1999, p. 251-272.

1998 -- George SL. Clinical trials audit and quality control. In: Armitage P, Colton T., eds. Encyclopedia of Biostatistics. New York: John Wiley and Sons, 1998:

1998 -- Pubmed # 9824521 -- Goodman SN, Altman DG, George SL. Statistical reviewing policies of medical journals: caveat lector? J Gen Intern Med. 1998 Nov;13(11):753-6.

1998 -- Pubmed # 9741868 -- Knatterud GL, Rockhold FW, George SL, Barton FB, Davis CE, Fairweather WR, Honohan T, Mowery R, O'Neill R. Guidelines for quality assurance in multicenter trials: a position paper. Control Clin Trials. 1998 Oct;19(5):477-93.

1997 -- George SL. Perspectives on scientific misconduct and fraud in clinical trials. Chance 1997; 10:3-5.

1996 -- Pubmed # 8648395 -- George SL. Reducing patient eligibility criteria in cancer clinical trials. J Clin Oncol. 1996 Apr;14(4):1364-70.

1996 -- George,S.L.. Reducing patient eligibility criteria in cancer clinical trials. J. Clin Oncol. 14:1364-1370, 1996.

1995 -- Pubmed # 7545222 -- Bennett CL, Smith TJ, George SL, Hillner BE, Fleishman S, Niell HB. Free-riding and the prisoner's dilemma: problems in funding economic analyses of phase III cancer clinical trials. J Clin Oncol. 1995 Sep;13(9):2457-63.

1994 -- Pubmed # 7973212 -- George SL, Li C, Berry DA, Green MR. Stopping a clinical trial early: frequentist and Bayesian approaches applied to a CALGB trial in non-small-cell lung cancer. Stat Med. 1994 Jul 15-30;13(13-14):1313-27.

1994 -- George,S.L., Li,C., Berry,D.A. and Green,M.R. Stopping a clinical trial early: Frequentist and Bayesian approaches applied to a CALGB trial in non-small cell lung cancer. Stat Med, 13:1313-1328, 1994.

1994 -- Pubmed # 7973220 -- Harrington D, Crowley J, George SL, Pajak T, Redmond C, Wieand S. The case against independent monitoring committees. Stat Med. 1994 Jul 15-30;13(13-14):1411-4.

1993 -- Pubmed # 8119066 -- Peterson B, George SL. Sample size requirements and length of study for testing interaction in a 2 x k factorial design when time-to-failure is the outcome [corrected] Control Clin Trials. 1993 Dec;14(6):511-22.

1984 -- George SL: The required size and length of a clinical trial. In Cancer Clinical Trials. Buyse,ME, et al (eds), Oxford, Oxford University Press, 1984, pp 287-310.