J H Powers

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi request reprint Voriconazole versus liposomal amphotericin B in patients with neutropenia and persistent fever
    John H Powers
    N Engl J Med 346:289-90. 2002
  2. ncbi request reprint Correlation between bacteriologic eradication and clinical cure in acute otitis media
    John H Powers
    Pediatr Infect Dis J 23:976; author reply 976-8. 2004
  3. ncbi request reprint Issues in clinical trials of prophylaxis of fungal infections
    John H Powers
    Antimicrobial Drug Development and Resistance Initiatives, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD 20850, USA
    Clin Infect Dis 39:S211-7. 2004
  4. ncbi request reprint Antimicrobial drug development--the past, the present, and the future
    J H Powers
    US Food and Drug Administration, Rockville, MD 20850, USA
    Clin Microbiol Infect 10:23-31. 2004
  5. ncbi request reprint Considerations in clinical trials of combination antifungal therapy
    John H Powers
    Antimicrobial Drug Development and Resistance Initiatives, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20850, USA
    Clin Infect Dis 39:S228-35. 2004
  6. ncbi request reprint Microbiologic surrogate end points in clinical trials of infectious diseases: example of acute otitis media trials
    John H Powers
    Office of Antimicrobial Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Rockville, Maryland, USA
    Pharmacotherapy 25:109S-123S. 2005
  7. ncbi request reprint Development of drugs for antimicrobial-resistant pathogens
    John H Powers
    Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland, USA
    Curr Opin Infect Dis 16:547-51. 2003
  8. doi request reprint Design, conduct, and analysis of clinical trials in disease due to methicillin-resistant Staphylococcus aureus
    J H Powers
    Scientific Applications International, in support of Collaborative Clinical Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA
    Clin Pharmacol Ther 86:244-7. 2009
  9. pmc Recommendations for improving the design, conduct, and analysis of clinical trials in hospital-acquired pneumonia and ventilator-associated pneumonia
    John H Powers
    Scientific Applications International Corporation, Collaborative Clinical Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, George Washington University School of Medicine and University of Maryland School of Medicine, Bethesda, Maryland, USA
    Clin Infect Dis 51:S18-28. 2010
  10. ncbi request reprint Salvage therapy trials in invasive fungal disease: challenges and opportunities
    John H Powers
    Clin Infect Dis 43:1456-60. 2006

Collaborators

Detail Information

Publications30

  1. ncbi request reprint Voriconazole versus liposomal amphotericin B in patients with neutropenia and persistent fever
    John H Powers
    N Engl J Med 346:289-90. 2002
  2. ncbi request reprint Correlation between bacteriologic eradication and clinical cure in acute otitis media
    John H Powers
    Pediatr Infect Dis J 23:976; author reply 976-8. 2004
  3. ncbi request reprint Issues in clinical trials of prophylaxis of fungal infections
    John H Powers
    Antimicrobial Drug Development and Resistance Initiatives, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD 20850, USA
    Clin Infect Dis 39:S211-7. 2004
    ..Standardization of the design of such clinical trials will allow more efficient development of new drugs and will allow clinicians to compare more accurately the safety and efficacy of prophylactic agents...
  4. ncbi request reprint Antimicrobial drug development--the past, the present, and the future
    J H Powers
    US Food and Drug Administration, Rockville, MD 20850, USA
    Clin Microbiol Infect 10:23-31. 2004
    ....
  5. ncbi request reprint Considerations in clinical trials of combination antifungal therapy
    John H Powers
    Antimicrobial Drug Development and Resistance Initiatives, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20850, USA
    Clin Infect Dis 39:S228-35. 2004
    ..A careful consideration of study design factors before the initiation of a trial will help obtain the most useful information for patients in this important area...
  6. ncbi request reprint Microbiologic surrogate end points in clinical trials of infectious diseases: example of acute otitis media trials
    John H Powers
    Office of Antimicrobial Products, Center for Drug Evaluation and Research, United States Food and Drug Administration, Rockville, Maryland, USA
    Pharmacotherapy 25:109S-123S. 2005
    ....
  7. ncbi request reprint Development of drugs for antimicrobial-resistant pathogens
    John H Powers
    Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland, USA
    Curr Opin Infect Dis 16:547-51. 2003
    ..At the same time, large pharmaceutical companies have indicated that they are devoting fewer resources to antimicrobial drug development...
  8. doi request reprint Design, conduct, and analysis of clinical trials in disease due to methicillin-resistant Staphylococcus aureus
    J H Powers
    Scientific Applications International, in support of Collaborative Clinical Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA
    Clin Pharmacol Ther 86:244-7. 2009
    ..Here we discuss issues that investigators should address in trial design, conduct, and analysis to evaluate overall effects or effects within subgroups according to causative organisms...
  9. pmc Recommendations for improving the design, conduct, and analysis of clinical trials in hospital-acquired pneumonia and ventilator-associated pneumonia
    John H Powers
    Scientific Applications International Corporation, Collaborative Clinical Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, George Washington University School of Medicine and University of Maryland School of Medicine, Bethesda, Maryland, USA
    Clin Infect Dis 51:S18-28. 2010
    ....
  10. ncbi request reprint Salvage therapy trials in invasive fungal disease: challenges and opportunities
    John H Powers
    Clin Infect Dis 43:1456-60. 2006
  11. pmc Antimicrobial drug resistance, regulation, and research
    Joshua P Metlay
    VA Medical Center, University of Pennsylvania School of Medicine, Center for Clinical Epidemiology and Biostatistics, Philadelphia, Pennsylvania 19104, USA
    Emerg Infect Dis 12:183-90. 2006
    ..Recent consultations and collaborations between regulators, academics, and industry are welcome. Efforts to coordinate regulatory measures would benefit from greater levels of international dialogue...
  12. ncbi request reprint FDA evaluation of antimicrobials: subgroup analysis
    John H Powers
    Chest 127:2298-9; authore reply 2300-1. 2005
  13. ncbi request reprint Anti-infective research and development--problems, challenges, and solutions
    John S Bradley
    Antimicrobial Availability Task Force of the Infectious Diseases Society of America, Alexandria, VA, USA
    Lancet Infect Dis 7:68-78. 2007
  14. ncbi request reprint Correlation between bacteriologic and clinical endpoints in trials of acute otitis media
    Rosemary Johann-Liang
    Pediatr Infect Dis J 22:936-7; author reply 937. 2003
  15. ncbi request reprint Tubes and ear infections
    John H Powers
    Pediatrics 113:178-9; author reply 178-9. 2004
  16. ncbi request reprint Trends in antimicrobial drug development: implications for the future
    Brad Spellberg
    Research and Education Institute and Department of Medicine, Harbor University of California, Los Angeles Medical Center, Torrance, California 90502, USA
    Clin Infect Dis 38:1279-86. 2004
    ..Despite the critical need for new antimicrobial agents, the development of these agents is declining. Solutions encouraging and facilitating the development of new antimicrobial agents are needed...
  17. ncbi request reprint Itraconazole versus fluconazole for antifungal prophylaxis
    John H Powers
    Ann Intern Med 140:580; author reply 581-2. 2004
  18. ncbi request reprint The United States Food and Drug Administration and noninferiority margins in clinical trials of antimicrobial agents
    John H Powers
    Clin Infect Dis 34:879-81. 2002
  19. doi request reprint Reassessing the design, conduct, and analysis of clinical trials of therapy for community-acquired pneumonia
    John H Powers
    Clin Infect Dis 46:1152-6. 2008
  20. doi request reprint Noninferiority and equivalence trials: deciphering 'similarity' of medical interventions
    John H Powers
    SAIC in Support of the Collaborative Clinical Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, MD, USA
    Stat Med 27:343-52. 2008
  21. ncbi request reprint Patient-reported outcomes to support medical product labeling claims: FDA perspective
    Donald L Patrick
    Food and Drug Administration, University of Washington, Seattle Quality of Life Group, Seattle, WA 98103 8652, USA
    Value Health 10:S125-37. 2007
    ....
  22. ncbi request reprint Increasing the efficiency of clinical trials of antimicrobials: the scientific basis of substantial evidence of effectiveness of drugs
    John H Powers
    Science Applications International Corporation SAIC in support of the Collaborative Clinical Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD 20892, USA
    Clin Infect Dis 45:S153-62. 2007
    ....
  23. ncbi request reprint Diagnosis and treatment of acute otitis media: evaluating the evidence
    John H Powers
    Scientific Applications International Corporation in support of the Collaborative Clinical Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, USA
    Infect Dis Clin North Am 21:409-26, vi. 2007
    ....
  24. ncbi request reprint Fluoroquinolone-resistant Campylobacter species and the withdrawal of fluoroquinolones from use in poultry: a public health success story
    Jennifer M Nelson
    Enteric Diseases Epidemiology Branch, Division of Foodborne, Bacterial and Mycotic Diseases, National Center for Zoonotic, Vectorborne, and Enteric Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA
    Clin Infect Dis 44:977-80. 2007
    ..Judicious use of fluoroquinolones and other antimicrobial agents in human and veterinary medicine is essential to preserve the efficacy of these important chemotherapeutic agents...
  25. ncbi request reprint Empirical antifungal therapy in febrile neutropenic patients: caution about composite end points and the perils of P values
    John H Powers
    Clin Infect Dis 39:1738-9; author reply 1739. 2004
  26. ncbi request reprint Lipid amphotericin B formulations as comparators in clinical trials
    John H Powers
    Clin Infect Dis 38:305-6; author reply 306-7. 2004
  27. ncbi request reprint Evaluating combination therapy in community-acquired pneumonia
    John H Powers
    Chest 125:353. 2004
  28. ncbi request reprint Levofloxacin and macrolides for treatment of Legionnaires disease: multiple comparisons give few answers
    Carl N Kraus
    Clin Infect Dis 41:416; author reply 416-7. 2005
  29. ncbi request reprint Sample size and the ethics of non-inferiority trials
    John H Powers
    Lancet 366:24-5. 2005
  30. ncbi request reprint Linezolid and vancomycin for methicillin-resistant Staphylococcus aureus nosocomial pneumonia: the subtleties of subgroup analyses
    John H Powers
    Chest 126:314-5; author reply 315-6. 2004