Michael P Fay

Summary

Affiliation: National Institutes of Health
Country: USA

Publications

  1. doi request reprint Weighted logrank tests for interval censored data when assessment times depend on treatment
    Michael P Fay
    National Institute of Allergy and Infectious Diseases, 6700 B Rockledge Dr, MSC 7630, Bethesda, MD 20892 7630, USA
    Stat Med 31:3760-72. 2012
  2. pmc Anthrax vaccine-induced antibodies provide cross-species prediction of survival to aerosol challenge
    Michael P Fay
    Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, 6700B Rockledge Drive, Bethesda, MD 20892 7630, USA
    Sci Transl Med 4:151ra126. 2012
  3. ncbi request reprint Accounting for variability in sample size estimation with applications to nonadherence and estimation of variance and effect size
    Michael P Fay
    National Institute of Allergy and Infectious Diseases, 6700 B Rockledge Drive, Bethesda, Maryland 20892 7609, USA
    Biometrics 63:465-74. 2007
  4. ncbi request reprint Estimating average annual percent change for disease rates without assuming constant change
    Michael P Fay
    National Institute of Allergy and Infectious Diseases, Bethesda, Maryland 20892, USA
    Biometrics 62:847-54. 2006
  5. ncbi request reprint Random marginal agreement coefficients: rethinking the adjustment for chance when measuring agreement
    Michael P Fay
    National Institute of Allergy and Infectious Diseases, 6700B Rockledge Dr MSC 7609, Bethesda, MD 20892 7609, USA
    Biostatistics 6:171-80. 2005
  6. ncbi request reprint Monitoring rare serious adverse events from a new treatment and testing for a difference from historical controls
    Michael P Fay
    Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, 6700B Rockledge Drive, Bethesda, MD 20892 7609, USA
    Clin Trials 4:598-610. 2007
  7. pmc Confidence intervals that match Fisher's exact or Blaker's exact tests
    Michael P Fay
    Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, MD 20892 7609, USA
    Biostatistics 11:373-4. 2010
  8. pmc Anti-apical-membrane-antigen-1 antibody is more effective than anti-42-kilodalton-merozoite-surface-protein-1 antibody in inhibiting plasmodium falciparum growth, as determined by the in vitro growth inhibition assay
    Kazutoyo Miura
    Malaria Vaccine Development Branch, National Institute of Allergy and Infectious Diseases, NIH, Rockville, MD 20852, USA
    Clin Vaccine Immunol 16:963-8. 2009
  9. pmc The IC(50) of anti-Pfs25 antibody in membrane-feeding assay varies among species
    Lediya Cheru
    National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD 20852, USA
    Vaccine 28:4423-9. 2010
  10. pmc Immunological responses against Plasmodium falciparum Apical Membrane Antigen 1 vaccines vary depending on the population immunized
    Kazutoyo Miura
    Malaria Vaccine Development Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD 20852, USA
    Vaccine 29:2255-61. 2011

Detail Information

Publications41

  1. doi request reprint Weighted logrank tests for interval censored data when assessment times depend on treatment
    Michael P Fay
    National Institute of Allergy and Infectious Diseases, 6700 B Rockledge Dr, MSC 7630, Bethesda, MD 20892 7630, USA
    Stat Med 31:3760-72. 2012
    ..Simulations were performed using the interval R package...
  2. pmc Anthrax vaccine-induced antibodies provide cross-species prediction of survival to aerosol challenge
    Michael P Fay
    Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, 6700B Rockledge Drive, Bethesda, MD 20892 7630, USA
    Sci Transl Med 4:151ra126. 2012
    ..0%) and 72.6% in rabbits (actual survival, 64.6%). These data add support for the use of TNA as an immunological bridge between species to extrapolate data in animals to predict anthrax vaccine effectiveness in humans...
  3. ncbi request reprint Accounting for variability in sample size estimation with applications to nonadherence and estimation of variance and effect size
    Michael P Fay
    National Institute of Allergy and Infectious Diseases, 6700 B Rockledge Drive, Bethesda, Maryland 20892 7609, USA
    Biometrics 63:465-74. 2007
    ..This latter situation, as well as several of the previous ones, is motivated by sample size calculations for a Phase II trial of a malaria vaccine candidate...
  4. ncbi request reprint Estimating average annual percent change for disease rates without assuming constant change
    Michael P Fay
    National Institute of Allergy and Infectious Diseases, Bethesda, Maryland 20892, USA
    Biometrics 62:847-54. 2006
    ..For the adaptive estimator, we show through simulation that the bootstrap confidence intervals give appropriate coverage...
  5. ncbi request reprint Random marginal agreement coefficients: rethinking the adjustment for chance when measuring agreement
    Michael P Fay
    National Institute of Allergy and Infectious Diseases, 6700B Rockledge Dr MSC 7609, Bethesda, MD 20892 7609, USA
    Biostatistics 6:171-80. 2005
    ..We describe the RMAC for nominal, ordinal and continuous data, and show through the delta method how to approximate the variances of some important special cases...
  6. ncbi request reprint Monitoring rare serious adverse events from a new treatment and testing for a difference from historical controls
    Michael P Fay
    Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, 6700B Rockledge Drive, Bethesda, MD 20892 7609, USA
    Clin Trials 4:598-610. 2007
    ..Controlled but small clinical trials have not detected any increase in the SAE using albendazole, and it is known to have added benefits; therefore, it is unethical to randomize patients to the old regimen...
  7. pmc Confidence intervals that match Fisher's exact or Blaker's exact tests
    Michael P Fay
    Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, MD 20892 7609, USA
    Biostatistics 11:373-4. 2010
    ..We explore these 2 versions of Fisher's exact test as well as an exact test suggested by Blaker (2000) and provide the R package exact2x2 which automatically assigns the appropriate matching interval to each of the 3 exact tests...
  8. pmc Anti-apical-membrane-antigen-1 antibody is more effective than anti-42-kilodalton-merozoite-surface-protein-1 antibody in inhibiting plasmodium falciparum growth, as determined by the in vitro growth inhibition assay
    Kazutoyo Miura
    Malaria Vaccine Development Branch, National Institute of Allergy and Infectious Diseases, NIH, Rockville, MD 20852, USA
    Clin Vaccine Immunol 16:963-8. 2009
    ..Our data provide a benchmark for antibody levels for future AMA1- or MSP1(42)-based vaccine development efforts in preclinical and clinical trials...
  9. pmc The IC(50) of anti-Pfs25 antibody in membrane-feeding assay varies among species
    Lediya Cheru
    National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD 20852, USA
    Vaccine 28:4423-9. 2010
    ..These data suggests that information obtained from animal studies which assess efficacy of TBV candidates may be difficult to translate to human immunization...
  10. pmc Immunological responses against Plasmodium falciparum Apical Membrane Antigen 1 vaccines vary depending on the population immunized
    Kazutoyo Miura
    Malaria Vaccine Development Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD 20852, USA
    Vaccine 29:2255-61. 2011
    ..Thus predicting immune responses from non-target populations is not desirable...
  11. pmc Plasmodium falciparum clearance rates in response to artesunate in Malian children with malaria: effect of acquired immunity
    Tatiana M Lopera-Mesa
    Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA
    J Infect Dis 207:1655-63. 2013
    ..Few baseline half-lives have been reported from Africa, where artemisinins were recently introduced...
  12. pmc Functional comparison of Plasmodium falciparum transmission-blocking vaccine candidates by the standard membrane-feeding assay
    Kazutoyo Miura
    Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, USA
    Infect Immun 81:4377-82. 2013
    ..This is the first study showing that the HAP2 protein of P. falciparum can induce transmission-blocking antibody. The current study supports the possibility of using this system for a comparative study with multiple TBV candidates. ..
  13. pmc Anaemia in a phase 2 study of a blood stage falciparum malaria vaccine
    Ruth D Ellis
    Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health NIAID NIH, Rockville, Maryland, USA
    Malar J 10:13. 2011
    ..5 g/dL) compared to those who received the comparator vaccine (Hiberix). This effect was one of many tested and was not significant after adjusting for multiple comparisons...
  14. ncbi request reprint Modeling the dissemination of mammography in the United States
    Kathleen A Cronin
    Statistical Research and Applications Branch, Division of Cancer Control and Population Sciences, Applied Research Branch, National Cancer Institute NIH, MSC 8317, Suite 504, 6116 Executive Boulevard, Bethesda, MD 20892 7359, USA
    Cancer Causes Control 16:701-12. 2005
    ..This paper presents a methodology for piecing together disparate data sources to obtain a comprehensive model for the use of mammography screening in the US population for the years 1975-2000...
  15. pmc A valid formulation of the analysis of noninferiority trials under random effects meta-analysis
    Erica H Brittain
    Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, MD 20892 7630, USA
    Biostatistics 13:637-49. 2012
    ..An example is used to illustrate practical issues...
  16. pmc Age-conditional probabilities of developing cancer
    Michael P Fay
    National Cancer Institute, 6116 Executive Blvd, Suite 504, MSC 8317, Bethesda, Maryland 20892 8317, USA
    Stat Med 22:1837-48. 2003
    ..this paper provides a comprehensive theoretical basis for estimation and inference about the age-conditional probability of developing a disease...
  17. pmc Geographic patterns of Plasmodium falciparum drug resistance distinguished by differential responses to amodiaquine and chloroquine
    Juliana Martha Sá
    Laboratory of Malaria and Vector Research and Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA
    Proc Natl Acad Sci U S A 106:18883-9. 2009
    ..Increasing use of AQ in Africa poses the threat of a selective sweep of highly AQ-resistant, CQ-resistant parasites with pfcrt and pfmdr1 mutations that are as advantaged and persistent as in South America...
  18. pmc Comparing the understanding of subjects receiving a candidate malaria vaccine in the United States and Mali
    Ruth D Ellis
    Malaria Vaccine Development Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland 20892, USA
    Am J Trop Med Hyg 83:868-72. 2010
    ....
  19. pmc Disruption of a Plasmodium falciparum multidrug resistance-associated protein (PfMRP) alters its fitness and transport of antimalarial drugs and glutathione
    Dipak Kumar Raj
    Laboratory of Malaria and Vector Research, Research Technologies Branch, and Biostatistical Research Branch, NIAID, National Institutes of Health, Bethesda, Maryland 20892 8132, USA
    J Biol Chem 284:7687-96. 2009
    ..The results suggest that PfMRP plays a role in the efflux of glutathione, CQ, and QN and contributes to parasite responses to multiple antimalarial drugs, possibly by pumping drugs outside the parasite...
  20. pmc Phase 1 trial of the Plasmodium falciparum blood stage vaccine MSP1(42)-C1/Alhydrogel with and without CPG 7909 in malaria naïve adults
    Ruth D Ellis
    Malaria Vaccine Development Branch, National Institute of Allergy and Infectious Diseases National Institutes of Health, Rockville, Maryland, USA
    PLoS ONE 5:e8787. 2010
    ..To improve the level of antibody response, MSP1(42)-C1 was formulated with Alhydrogel plus the novel adjuvant CPG 7909...
  21. ncbi request reprint Costs of treatment for elderly women with early-stage breast cancer in fee-for-service settings
    Joan L Warren
    Applied Research Program, National Cancer Institute, Executive Plaza North, Rm 4005, 6130 Executive Blvd, Bethesda, MD 20892 7344, USA
    J Clin Oncol 20:307-16. 2002
    ....
  22. pmc Relapse following discontinuation of imatinib mesylate therapy for FIP1L1/PDGFRA-positive chronic eosinophilic leukemia: implications for optimal dosing
    Amy D Klion
    Laboratory of Parasitic Diseases, National Institutes of Allergy and Infectious Diseases, National Institutes of Health NIH, Bethesda, MD 20892, USA
    Blood 110:3552-6. 2007
    ..This trial was registered at http://www.clinicaltrials.gov as no. NCT00044304...
  23. ncbi request reprint KIT D816V-associated systemic mastocytosis with eosinophilia and FIP1L1/PDGFRA-associated chronic eosinophilic leukemia are distinct entities
    Irina Maric
    Department of Laboratory Medicine, Clinical Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA
    J Allergy Clin Immunol 120:680-7. 2007
    ..It is of paramount importance, however, to distinguish between these 2 groups of patients because of differences in clinical sequelae, prognoses, and selection of treatment...
  24. pmc Phase 1 trial of malaria transmission blocking vaccine candidates Pfs25 and Pvs25 formulated with montanide ISA 51
    Yimin Wu
    Malaria Vaccine Development Branch, National Institute of Allergy and Infectious Diseases, Rockville, Maryland, United States of America
    PLoS ONE 3:e2636. 2008
    ..This single blinded, dose escalating, controlled Phase 1 study assessed the safety and immunogenicity of recombinant Pfs25 and Pvs25 formulated with Montanide ISA 51, a water-in-oil emulsion...
  25. pmc Human immunity and the design of multi-component, single target vaccines
    Allan Saul
    Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, United States of America
    PLoS ONE 2:e850. 2007
    ..As a consequence, there is little practical experience for deciding where the increased complexity of vaccines with multiple defined immunogens vaccines targeting single pathogens will be justifiable...
  26. pmc A Phase 1 study of the blood-stage malaria vaccine candidate AMA1-C1/Alhydrogel with CPG 7909, using two different formulations and dosing intervals
    Ruth D Ellis
    Malaria Vaccine Development Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Twinbrook I, MD 20852, USA
    Vaccine 27:4104-9. 2009
    ..037, 95% CI 1.03, 4.28). In vitro growth inhibition followed the antibody level: median inhibition was 51% (0,1 month interval) versus 85% (0,2 month interval) in antibody from samples taken 2 weeks post-second vaccination (p=0.056)...
  27. pmc Pointwise confidence intervals for a survival distribution with small samples or heavy censoring
    Michael P Fay
    National Institute of Allergy and Infectious Diseases, 6700B Rockledge Dr MSC 7630, Bethesda, MD 20892 7630, USA
    Biostatistics 14:723-36. 2013
    ..Because the BPCP is easy to implement, offers protection in settings when other methods fail, and essentially matches other methods when they succeed, it should be the method of choice...
  28. pmc A potential role for plasma uric acid in the endothelial pathology of Plasmodium falciparum malaria
    Neida K Mita-Mendoza
    Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, USA
    PLoS ONE 8:e54481. 2013
    ..Since UA is associated with endothelial inflammation in non-malaria diseases, we hypothesized that elevated UA levels contribute to the endothelial pathology of P. falciparum malaria...
  29. pmc Artemisinin-resistant Plasmodium falciparum in Pursat province, western Cambodia: a parasite clearance rate study
    Chanaki Amaratunga
    Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20852, USA
    Lancet Infect Dis 12:851-8. 2012
    ..We investigated contributions of both parasite genetics and host factors to the artemisinin-resistance phenotype in Pursat, western Cambodia...
  30. doi request reprint Does treatment effect depend on control event rate? Revisiting a meta-analysis of suicidality and antidepressant use in children
    Michael A Proschan
    Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA
    Clin Trials 7:109-17; discussion 118-120. 2010
    ..Presenting data from a previously published meta-analysis of the effect of antidepressants in children on suicidality, they suggest a relationship between the control event rate and relative risk...
  31. doi request reprint Chop-lump tests for vaccine trials
    Dean Follmann
    Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, MSC 7609, Bethesda, Maryland 20892, USA
    Biometrics 65:885-93. 2009
    ..The chop-lump tests are compared to established tests via simulation for planned HIV and malaria vaccine trials. A reanalysis of the first phase III HIV vaccine trial is used to illustrate the method...
  32. pmc Changes in the plasmodial surface anion channel reduce leupeptin uptake and can confer drug resistance in Plasmodium falciparum-infected erythrocytes
    Godfrey Lisk
    Laboratory of Malaria and Vector Research, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland 20892, USA
    Antimicrob Agents Chemother 52:2346-54. 2008
    ..Drug development based on such compounds should proceed cautiously in light of possible resistance development though the selection of PSAC mutants...
  33. ncbi request reprint Impact of reporting delay and reporting error on cancer incidence rates and trends
    Limin X Clegg
    Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD 20892, USA
    J Natl Cancer Inst 94:1537-45. 2002
    ..We studied the impact of reporting delay and reporting error on incidence rates and trends for cancers of the female breast, colorectal, lung/bronchus, prostate, and melanoma...
  34. ncbi request reprint Trends in drinking among Americans age 18 and younger: 1975-2002
    Vivian B Faden
    Division of Epidemiology and Prevention Research, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, Maryland 20892 9304, USA
    Alcohol Clin Exp Res 28:1388-95. 2004
    ..In this study, we applied joinpoint statistical methodology to three national data sets to analyze trends in drinking by youth, age 18 and under, for the period 1975 to 2002...
  35. pmc Quantification of the infectious dose of Leishmania major transmitted to the skin by single sand flies
    Nicola Kimblin
    Laboratories of Parasitic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA
    Proc Natl Acad Sci U S A 105:10125-30. 2008
    ..The low dose resulted in only minor pathology but a higher parasite titer in the chronic phase, and it established the host as an efficient long-term reservoir of infection back to vector sand flies...
  36. pmc In vivo imaging reveals an essential role for neutrophils in leishmaniasis transmitted by sand flies
    Nathan C Peters
    Laboratory of Parasitic Diseases, National Institute of Allergy and Infectious Diseases, Bethesda, MD 20892, USA
    Science 321:970-4. 2008
    ..Thus, L.m. appears to have evolved to both evade and exploit the innate host response to sand fly bite in order to establish and promote disease...
  37. pmc Impact of a Plasmodium falciparum AMA1 vaccine on antibody responses in adult Malians
    Alassane Dicko
    Malaria Research and Training Center, Department of Hematology, University of Bamako, Bamako, Mali
    PLoS ONE 2:e1045. 2007
    ..After a peak 14 days following the second vaccination, antibody levels decreased to baseline levels one year later at the time of the third vaccination that induced little or no increase in antibody levels...
  38. pmc Phase 1 study of a combination AMA1 blood stage malaria vaccine in Malian children
    Alassane Dicko
    Malaria Research and Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy and Dentistry, University of Bamako, Bamako, Mali
    PLoS ONE 3:e1563. 2008
    ..The aim of this study was to assess the safety and immunogenicity of this vaccine in young children in a malaria endemic area...
  39. ncbi request reprint Comparability of segmented line regression models
    Hyune Ju Kim
    Department of Mathematics, Syracuse University, Syracuse, New York 13244 1150, USA
    Biometrics 60:1005-14. 2004
    ..The tests are applied to compare female lung cancer mortality rates between two registry areas and also to compare female breast cancer mortality rates between two states...
  40. pmc Protection induced by Plasmodium falciparum MSP1(42) is strain-specific, antigen and adjuvant dependent, and correlates with antibody responses
    Jeffrey A Lyon
    Division Malaria Vaccine Development, Walter Reed Army Institute of Research, Silver Spring, Maryland, United States of America
    PLoS ONE 3:e2830. 2008
    ..Development of an effective MSP1(42) vaccine against erythrocytic stage P. falciparum infection will depend not only on antigen quality, but also upon the selection of an optimal adjuvant component...
  41. ncbi request reprint Weight change and the risk of late-onset breast cancer in the original Framingham cohort
    Kathy L Radimer
    Division of Health and Nutrition Examination Surveys, National Center for Health Statistics, Centers for Disease Control and Prevention, Hyattsville, MD 20782, USA
    Nutr Cancer 49:7-13. 2004
    ..This study assesses the relation of adult weight change overall and at specific, hormonally relevant times with diagnosis of a first breast cancer after age 55 (late onset)...