S S Ellenberg

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi request reprint Are all monitoring boundaries equally ethical?
    Susan S Ellenberg
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
    Control Clin Trials 24:585-8. 2003
  2. ncbi request reprint Monitoring the safety of vaccines: assessing the risks
    Susan S Ellenberg
    Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Maryland, USA
    Drug Saf 25:145-52. 2002
  3. ncbi request reprint Analytical, practical and regulatory issues in prevention studies
    Susan S Ellenberg
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA, 1401 Rockville Pike, HFM 210, Rockville, MD 20852, USA
    Stat Med 23:297-303. 2004
  4. ncbi request reprint Independent data monitoring committees: rationale, operations and controversies
    S S Ellenberg
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U S Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852 1448, U S A
    Stat Med 20:2573-83. 2001
  5. ncbi request reprint Evaluating the safety of combination vaccines
    S S Ellenberg
    Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852 1448, USA
    Clin Infect Dis 33:S319-22. 2001
  6. ncbi request reprint Should statisticians reporting to data monitoring committees be independent of the trial sponsor and leadership?
    Susan S Ellenberg
    Center for Biologics Evaluation and Research, U S Food and Drug Administration, Rockville, MD 20852, USA
    Stat Med 23:1503-5. 2004
  7. ncbi request reprint Safety considerations for new vaccine development
    S S Ellenberg
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, MD, USA
    Pharmacoepidemiol Drug Saf 10:411-5. 2001
  8. ncbi request reprint The epidemiology of fatalities reported to the vaccine adverse event reporting system 1990-1997
    L E Silvers
    US Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Bethesda, MD, USA
    Pharmacoepidemiol Drug Saf 10:279-85. 2001
  9. ncbi request reprint Infant immunization with acellular pertussis vaccines in the United States: assessment of the first two years' data from the Vaccine Adverse Event Reporting System (VAERS)
    M M Braun
    Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
    Pediatrics 106:E51. 2000
  10. ncbi request reprint Neonatal deaths after hepatitis B vaccine: the vaccine adverse event reporting system, 1991-1998
    M T Niu
    Division of Biostatistics and Epidemiology, Center for Biologic Evaluation and Research, US Food and Drug Administration, Rockville, MD 20852 1448, USA
    Arch Pediatr Adolesc Med 153:1279-82. 1999

Collaborators

Detail Information

Publications21

  1. ncbi request reprint Are all monitoring boundaries equally ethical?
    Susan S Ellenberg
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
    Control Clin Trials 24:585-8. 2003
  2. ncbi request reprint Monitoring the safety of vaccines: assessing the risks
    Susan S Ellenberg
    Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Maryland, USA
    Drug Saf 25:145-52. 2002
    ....
  3. ncbi request reprint Analytical, practical and regulatory issues in prevention studies
    Susan S Ellenberg
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA, 1401 Rockville Pike, HFM 210, Rockville, MD 20852, USA
    Stat Med 23:297-303. 2004
    ....
  4. ncbi request reprint Independent data monitoring committees: rationale, operations and controversies
    S S Ellenberg
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U S Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852 1448, U S A
    Stat Med 20:2573-83. 2001
    ..It is also timely to consider the present and possible future regulatory status of data monitoring committees. Published in 2001 by John Wiley & Sons, Ltd...
  5. ncbi request reprint Evaluating the safety of combination vaccines
    S S Ellenberg
    Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852 1448, USA
    Clin Infect Dis 33:S319-22. 2001
    ....
  6. ncbi request reprint Should statisticians reporting to data monitoring committees be independent of the trial sponsor and leadership?
    Susan S Ellenberg
    Center for Biologics Evaluation and Research, U S Food and Drug Administration, Rockville, MD 20852, USA
    Stat Med 23:1503-5. 2004
    ..We have invited commentary on this issue from several statisticians with substantial experience in clinical trials and interim data monitoring...
  7. ncbi request reprint Safety considerations for new vaccine development
    S S Ellenberg
    Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, MD, USA
    Pharmacoepidemiol Drug Saf 10:411-5. 2001
    ....
  8. ncbi request reprint The epidemiology of fatalities reported to the vaccine adverse event reporting system 1990-1997
    L E Silvers
    US Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Bethesda, MD, USA
    Pharmacoepidemiol Drug Saf 10:279-85. 2001
    ..To examine the fatalities reported to the federally administered Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system, in its first 7 years...
  9. ncbi request reprint Infant immunization with acellular pertussis vaccines in the United States: assessment of the first two years' data from the Vaccine Adverse Event Reporting System (VAERS)
    M M Braun
    Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
    Pediatrics 106:E51. 2000
    ..To evaluate the safety of infant immunization with acellular pertussis vaccines in the United States...
  10. ncbi request reprint Neonatal deaths after hepatitis B vaccine: the vaccine adverse event reporting system, 1991-1998
    M T Niu
    Division of Biostatistics and Epidemiology, Center for Biologic Evaluation and Research, US Food and Drug Administration, Rockville, MD 20852 1448, USA
    Arch Pediatr Adolesc Med 153:1279-82. 1999
    ..To evaluate reports of neonatal deaths (aged 0-28 days) after hepatitis B (HepB) immunization reported to the national Vaccine Adverse Event Reporting System (VAERS)...
  11. pmc The complicated task of monitoring vaccine safety
    S S Ellenberg
    Division of Biostatistics and Epidemiology, FDA, USA
    Public Health Rep 112:10-20; discussion 21. 1997
    ..A continual effort to monitor these data effectively and to develop more precise ways of assessing risks of vaccines is necessary to ensure public confidence in immunization programs...
  12. ncbi request reprint Pediatric deaths reported after vaccination: the utility of information obtained from parents
    Linda E Silvers
    U S Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Rockville, Maryland 20855, USA
    Am J Prev Med 22:170-6. 2002
    ..This investigation explored whether routinely interviewing parents for follow-up of VAERS pediatric deaths would provide additional information important to vaccine safety...
  13. ncbi request reprint Monitoring data on data monitoring
    Susan S Ellenberg
    Clin Trials 1:6-8. 2004
  14. ncbi request reprint Marketing drugs too early in testing
    Colin B Begg
    Science 312:195. 2006
  15. doi request reprint Media coverage of the measles-mumps-rubella vaccine and autism controversy and its relationship to MMR immunization rates in the United States
    Michael J Smith
    Division of Infectious Diseases, Children s Hospital of Philadelphia, Philadelphia, Pennsylvania, USA
    Pediatrics 121:e836-43. 2008
    ..The purpose of this work was to assess the association between media coverage of the MMR-autism controversy and MMR immunization in the United States...
  16. pmc Evaluating the safety of new vaccines: summary of a workshop
    Susan S Ellenberg
    Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD, USA
    Am J Public Health 95:800-7. 2005
    ..The advantages and disadvantages of conducting large controlled trials before licensure or widespread use of a new vaccine were discussed. We summarize these presentations and discussions...
  17. pmc A global perspective on vaccine safety and public health: the Global Advisory Committee on Vaccine Safety
    Peter I Folb
    Medical Research Council, PO Box 19070, Tygerberg 7505, Cape Town, South Africa
    Am J Public Health 94:1926-31. 2004
    ....
  18. ncbi request reprint Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001
    Weigong Zhou
    Epidemic Intelligence Service Program, Epidemiology Program Office, CDC, USA
    MMWR Surveill Summ 52:1-24. 2003
    ..Therefore, postmarketing monitoring of adverse events after vaccinations is essential. The cornerstone of monitoring safety is review and analysis of spontaneously reported adverse events...
  19. ncbi request reprint Is the use of placebo controls ethically permissible in clinical trials of agents intended to reduce fractures in osteoporosis?
    Baruch A Brody
    Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas, USA
    J Bone Miner Res 18:1105-9. 2003
    ..Active control trials are permissible and desirable if they can be designed and conducted in ways that overcome the interpretive difficulties often associated with such trials...
  20. ncbi request reprint Adverse event reports following vaccination for Lyme disease: December 1998-July 2000
    Sarah L Lathrop
    Centers for Disease Control and Prevention, Epidemic Intelligence Service, Atlanta, GA 30333, USA
    Vaccine 20:1603-8. 2002
    ..Although events reported to VAERS are not necessarily causally associated with vaccination, VAERS reports can be used to identify possible safety concerns that occur at too low a rate to have been identified prior to licensure...
  21. pmc Adverse event detection in drug development: recommendations and obligations beyond phase 3
    Jesse A Berlin
    Johnson and Johnson Pharmaceutical Research and Development, 1125 Trenton Harbourton Rd, PO Box 200, Mail Stop K 304, Titusville, NJ 08560, USA
    Am J Public Health 98:1366-71. 2008
    ..More work is needed in analysis of data from spontaneous reports of adverse effects and automated databases, design of ad hoc studies, and design of economically feasible large randomized studies...