Publications

Office of the Director: Anello, Charles (1999). Emerging and Recurrent Issues in Drug Development. Statistics in Medicine. 18: 2301-2309. Anello, Charles; O'Neill, Robert (1996). Does Research Synthesis Have a Place in Drug Development Policy? Synopsis of Issues: Assessment of Safety and Postmarketing Surveillance. Clinical Research & Regulatory Affairs. 13(1): 13-21. Anello, Charles; Fleiss, J.L. (1995). Exploratory or Analytic Meta-Analysis: Should we Distinguish Between Them?. Journal of Clinical Epidemiology. O'Neill, Robert T. (2002) Regulatory Perspectives on Data Monitoring.  Statistics in Medicine; 21, 2831-2842 O'Neill, Robert T.; Szarfman, Ana (1999)  Comment on:  Bayesian Data Mining in Large Frequency Tables with an Application to the FDA Spontaneous Reporting System.  The American Statistician; 190-196. O'Neill, Robert T. (1998) The Assessment of Safety.  Biopharmaceutical Statistics for Drug Development; Chapter 13; edited by Karl Peace, Marcel Dekker. O'Neill, Robert T.; Hung; Bauer; Kohne (1997) The Behavior of the P Value When the Alternative Hypothesis is True.  Biometrics; Volume 53; 11-22. O'Neill, Robert T. (1997) Secondary Endpoints Cannot be Validly Analyzed if the Primary Endpoint does not Demonstrate Clear Statistical Significance.  Controlled Clinical Trials; 18:  550-556. O'Neill, Robert T. (1997) Sequential Case-Control Studies.  Chapter in Encyclopedia of Biostatistics; John Wiley & Sons, Ltd. O'Neill, Robert T. (1994) Statistical Analysis of Clinical Data.  International Pharmaceutical Product Registration; Chapter 22.  Edited by A. Cartwright and B. Matthews, Ellis Horwood, Ltd.    Division of Biometrics I: Chi, George Y.H.; Jin, Kun; Chen, Gang (2003).  Some Statistical Issues of Relevance to Confirmatory Trials.  Advanced Medical Statistics,  World Scientific Publishing Company. Chi, George Y.H.; Chen, Gang; Rothmann, Mark (2003).  Active Control Trials.  Encyclopedia of Biopharmaceutical Statistics, Marcel-Dekker. Rothmann, Mark; Li, N.; Chen, Gang; Chi, George Y.H.; Temple, Robert; Tsou, H. (2003).  Design and Analysis of Non-Inferiority Mortality Trials in Oncology.  Statistics in Medicine.  Vol. 22  No.2  pp. 239-264. Hung, H.M.J.; Wang, S.J.; Tsong, Yi; Lawrence, John; O'Neill, Robert (2002).  Some Fundamental Issues with Non-Inferiority Testing in Active Controlled Clinical Trials.  Statistics in Medicine.  22: 213-225. Hung, H.M.J. (2000).  Evaluation of a Combination Drug with Multiple Doses in Unbalanced Factorial Design Clinical Trials.  Statistics in Medicine.  19: 2079-2087. Cui, L.; Hung, H.M.J.; Wang, S.J. (1999).  Modification of a Sample Size in Groups Sequential Clinical Trials.  Biometrics.  55: 853-857.   Division of Biometrics II: Wang, S.J.; Hung, H.M.J. (2003). Assessing Treatment Efficacy in Non-Inferiority Trials.  Controlled Clinical Trials,  24(2), 147-155. Wang, S.J.; Hung, H.M.J. (2003). TACT Method for Non-Inferiority Testing in Active Controlled Trials.  Statistics in Medicine, Special Issue:  Non-Inferiority Trials, 22(2), 227-238. Chen, Wen-Jen and Tsong, Yi (2003).   Significance Levels for Stability Pooling Test: A Simulation Study, Journal of Biopharmaceutical Statistics. Rashid, M. M. (2003).  Rank-based Tests for Non-inferiority and Equivalence Hypotheses in Multi-Center Clinical Trials Using Mixed Models. Statistics in Medicine, 22(2),291-311. Wang, S.J.; Winchell, C.J.; McCormick, C.G.; Nevius, S.E.; O'Neill, R.T..  (2002). Short of Complete Abstinence:  An Analysis Exploration of Multiple Drinking Episodes in Alcoholism Treatment Trials.  Alcoholism:  Clinical and Experimental Research, 26(12): 1803-1809. Permutt, Thomas (2000).  Adjustment for Covariates, Encyclopedia of Biopharmaceutical Statistics, 1st Edition., Edited by S.C. Chow and Published by Dekker    Division of Biometrics III: Lin, T.Y.; Chen, C.W. (2003).   Overview of Stability Study Designs, Journal of Biopharmaceutical Statistics., Volume 13, Number 3, pp. 337-354. Viraraghavan, R.; Chakravarty, A.G.; Soreth, J. (2002).  Cefotetan-Induced Haemoolytic Anaemia, A Review of 85 Cases.  Adv. Drug React Toxicol Rev, 21 91-2, pp. 101-107. Lu, H.; Huque, M. (2001).   Understanding Pooled Analysis and Interaction Testing, Biometric Journal., 43 (7):  909-923. Al-Osh, M.; Lee, S.J. (2001).   A Simple Approach for Generating Correlated Binary Variates, Journal of Statistical Computation and Simulation, Volume 70, pp 231-255. Sankoh, A.J.; Al-Osh, M.; Huque, M.F.  (1999).   On the Utility of the Dirichlet Distribution for Meta-Analysis of Clinical Studies, Journal of Biopharmaceutical Statistics, 9:  289-306. Lin, K.K.; Rahman, M.A.  (1998).   Overall False Positives Rates in Tests for Linear Trend in Tumor Incidence in Animal Carcinogenicity Studies of New Drugs, Journal of Biopharmaceutical Statistics, Volume 8, Number 1. Huque, M.F.; Sankoh, A.J.  (1997).   A Reviewer's Perspective on Multiple Endpoint Issues in Clinical Trials, Journal of Biopharmaceutical Statistics in Medicine, 7(4) 545-564. Smith, F.  (1996).   Mixed Model Analysis of Incomplete Longitudinal Data from a High-Dose Trial of Tacrine (Cognex®) in Alzheimer's Patients, Journal of Biopharmaceutical Statistics, 6, 59-67. Smith, F.B.; Helms, R.W.  (1995).   EM Mixed Model Analysis of Data from Informatively Censored Normal Distributions, Biometrics, 51, 425-436. Huque, M.F.; Dubey, S.D.  (1994).   A Meta-Analysis Methodology for Utilizing Study-Level Covariate Information from Clinical Trials, Communications in  Statistics - Theory & Methods, 23 (2). Zhou, S.Y.J.; Kingsley, L.A.; Taylor, J.M.G.; Chmiel, J.S.; He, D.Y.; Hoover, D.R.  (1993).   A Method to Test for a Recent Increase in HIV-1 Seroconversion Inicidence.  Results from the Multi-Center AIDS Cohort Study (MACS), Statistics in Medicine, Volume 12, Number 2. Wittes, J.; Brittain, E. (1990).   The Role of Internal Pilot Studies in Increasing the Efficiency of Clinical Trials, Statistics in Medicine, 9:  65-72.

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