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Biostatistics Research Branch (BRB)

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Erica H. Brittain, Ph.D.

Mathematical Statistician


Clinical Trial Methodology, Non-inferiority Trials, Adaptive Designs, Subjective Endpoints

Additional Information

Bio (PDF)


Brittain E. Book review of “Design and analysis of non-inferiority trials” by Rothman, Wiens, and Chan.  Australian and New Zealand Journal of Statistics, 2012; 54: 127-129.

Proschan M, Brittain E, Kammerman L.  Reply to Berger’s “Letter to Editor ‘Comment on Proschan et al. (2011), Out of the frying plan and into the fire?’”. Biometrics 2012; 68: 990-991.

Brittain EH, Fay MP, Follmann DA.  A valid formulation of the analysis of non-inferiority trials under random effects meta-analysis.  Biostatistics 2012; 13: 637-649.

Fay MP, Brittain EH, Proschan MA.  Pointwise confidence intervals for a survival distribution with small samples or heavy censoring.  Biostatistics 2013; 14: 723-736.

Chan EC, Yun B, Bandara G, Simakova O, Brittain E, Scott L, Dyer KL, Klion AD, Maric I, Gilfillan AM, Metcalfe DD, Wilson TM.  KIT GNNK splice variants: Expression in systemic mastocytosis and influence on the activating potential of the D816V mutation in mast cells.  Experimental Hematology 2013; 41: 870-881.

Follmann D, Brittain E, Powers JH. Discordant minimum inhibitory concentration analysis: a new path of licensure for anti-infective drugs. Clinical Trials2013; 10: 876-885.

Fay MP, Proschan MA, Brittain E.  Combining one-sample confidence procedures for inference in the two-sample case.  Biometrics (in press)

Brittain E, Schlesselman J, and Stadel BV. Cost of case-control studies. American Journal of Epidemiology 1981; 114:234-243.

Brittain E. Probability of coronary heart disease developing.  Western Journal of Medicine 1982; 136: 86-89.

Brittain E and Schlesselman JJ. Optimal allocation for the comparison of proportions.  Biometrics 1982; 38: 1003-1009

Davis CE and Brittain E. Robustness of progressively censored comparison of exponential survival curves to departure from exponential distribution. “Biostatistics: Statistics in biomedical, public health and environmental sciences” PK Sen (editor). Elesvier Science Publisher, Amsterdam 1985; 31-38.

Taler S, Coulam C, Annegers JF, and Brittain E. Case Control study of galactorrhea and its relationship to the use of oral contraceptives.  Obstetrics and Gynecology 1985; 65: 665-668.

Brittain EH. P-values for the multi-sample Kolmogorov-Smirnov test using the expanded Bonferroni approximation.  Communication in Statistics-Theory and Methods 1987; 16:821-835.

Farnsworth WH, Hoeg JM, Maher M, Brittain EH, Sherrins RJ, and Brewer RB. Testicular function of type 11 hyperlipoproteinemic patients treated with lovastatin (mevinolin) or neomycin. Journal of Clinical Endocrinology and Metabolism 1987; 65: 546-550.

McMahon S, Cutler J, Brittain E, and Higgins M. Obesity and hypertension: Epidemiological and clinical issues. European Heart Journal 1987; 8:57-70

Tracy CM, Winkler J, Brittain EH, Leon MB, Epstein SE, and Bonow RO. Determinants of ventricular arrhythmias in mildly symptomatic patients with coronary artery disease and influence of inducible left ventricular dysfunction on arrhythmia frequency. Journal of the American College of Cardiology 1987; 9: 483-488.

Young N, Griffith P, Brittain E, Elfenbeing G, Gardner F, Huang A, Harmon D, Hewlett J, Fay J, Mangan K, Morrison F, Sensenbrenner L, Shadduck R, Wang W, Zaroulis C, and Zuckerman K. A multicenter trial of antithymocyte globulin in aplastic anemia and related diseases. Blood 1988; 72: 1861-1869.

Brittain E and Wittes J. Factorial designs in clinical trials: the effects of noncompliance and subadditivity. Statistics in Medicine 1989; 8: 161 –171.

Mazzotta G, Bonow RO, Pace L, Brittain E, and Epstein SE. Relation between exertional ischemia and prognosis in mildly symptomatic patients with single or double vessel coronary artery disease and left venticular dysfunction at rest. Journal of the American College of Cardiology 1989; 13: 567-573.

Wittes J and Brittain E. The role of internal pilot studies in increasing the efficiency of clinical trials.  Statistics in Medicine 1990; 9: 65-72.

Cutler JA and Brittain E. Calcium and blood pressure. An epidemiologic perspective. American Journal of Hypertension 1990; 3: 137S-146S.

Brittain E and Wittes J.  The run-in period in clinical trials: the effect of misclassification on efficiency.  Controlled Clinical Trials 1990; 11: 327-338.

Satterfield S, Cutler JA, Langford HG, Applegate WB, Borhani NO, Brittain E, Cohen JD, Kuller JH, et al. Trial of hypertension prevention. Phase I design.  Annals of Epidemiology 1991; 1: 455-471.

Brittain E and Bailey K.  Optimization of multistage testing times and critical values in clinical trials. Biometrics 1993; 42; 763-772.

Brittain E and Wittes J. Power trips: the factorial design for binary outcomes. Proceedings of the biopharmaceutical section of the American Statistical Association, 1994.

Brittain E, Palensky J, Blood J, and Wittes J. Blinded subjective rankings as a method of assessing treatment effect: A large sample example from the Systolic Hypertension of the Elderly Program (SHEP). Statistics in Medicine 1997; 16: 681-693.

Wittes J, Schabenberger O, Zucker D, Brittain E, and Proschan M. Internal pilot studies I: type I error rate of the naïve t-test. Statistics in Medicine 1999; 18: 3481-3491

Zucker D, Wittes J, Schabenberger O, and Brittain E. Internal pilot studies II: comparison of various procedures. Statistics in Medicine 1999; 18: 3493-3509.

Powers JH, Ross DB, Brittain E, Albrecht R, and Goldberger MJ. The United States Food and Drug Administration and noninferiority margins in clinical trials of antimicrobial agents.  Clinical Infectious Disease 2002; 34: 879-881.

Brittain E and Lin D. A comparison of intent-to-treat and per-protocol results in antibiotic non-inferiority trials.  Statistics in Medicine 2005; 24: 1-10.

Kushnir-Sukhov NM, Brittain E, Reynolds JC, Akin C, and Metcalfe DD.  Elevated tryptase levels are associated with greater bone density in a cohort of patients with mastocytosis.  International Archives of Allergy and Immunology 2006; 139: 265-270.

Akin C, Soto D, Brittain E, Chhabra A, Schwartz LB, and Caughey GH. Tryptase haplotype in mastocytosis: relationship to disease variant and diagnostic utility of total tryptase levels. Journal of Clinical Immunology 2007; 123: 268-271.

Akin C, Scott L, Kocabas C, Kushnir-Sukhov N, Brittain E, Noel P, and Metcalfe D. Demonstration of an aberrant mast call population with clonal markers in a subset of patients with idiopathic anaphylaxis.  Blood 2007; 110: 2331-2333.

Brittain E, Follmann D, and Yang S. Dynamic comparison of Kaplan-Meier proportions: monitoring a randomized clinical trial with a long-term binary endpoint.  Biometrics2008; 64: 189-197.

Brittain E, Hu Z. Non-inferiority trial design and analysis with an ordered three-level categorical endpoint.  Journal of Biopharmaceutical Statistics 2009; 19: 685-699.

Komarow HD, Hu Z, Brittain E, Uzzaman A, Gaskins D, Metcalfe D.  Serum tryptase levels in atopic and nonatopic children.  Journal of Allergy and Clinical Immunology 2009; 124: 845-848.

Proschan MA, Brittain EH, Fay MP. Does treatment effect depend on control rate?  Revisiting a meta-analysis of suicidality and antidepressant use in children. Clinical Trials 2010; 7: 109-117.

Proschan MA, Brittain EH, Fay MP. Response to commentary. Clinical Trials 2010; 7: 120

Proschan M, Brittain E, Kammerman L. Minimize the use of minimization with unequal allocation. Biometrics 2011; 67: 1135-1141

Siegel AM, Heimall J, Freeman AF, Hsu A, Brittain E, Brenchley JM, Douek DC, Fahle GH, Cohen JI, Holland SM, Milner JD.  A critical role for STAT3 transcription factor signaling in the development and maintenance of human T cell memory.  Immunity 2011; 35: 806-818.

Brittain E, Follmann D. A hierarchical rank test for crossover trials with censored data.  Statistics in Medicine 2011; 30: 3507-3519.

Last Updated January 08, 2015