J H Powers
Affiliation: Food and Drug Administration
- Voriconazole versus liposomal amphotericin B in patients with neutropenia and persistent feverJohn H Powers
N Engl J Med 346:289-90. 2002
- Correlation between bacteriologic eradication and clinical cure in acute otitis mediaJohn H Powers
Pediatr Infect Dis J 23:976; author reply 976-8. 2004
- Issues in clinical trials of prophylaxis of fungal infectionsJohn 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...
- Antimicrobial drug development--the past, the present, and the futureJ H Powers
US Food and Drug Administration, Rockville, MD 20850, USA
Clin Microbiol Infect 10:23-31. 2004....
- Considerations in clinical trials of combination antifungal therapyJohn 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...
- Microbiologic surrogate end points in clinical trials of infectious diseases: example of acute otitis media trialsJohn 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....
- Development of drugs for antimicrobial-resistant pathogensJohn 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...
- Design, conduct, and analysis of clinical trials in disease due to methicillin-resistant Staphylococcus aureusJ 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...
- Recommendations for improving the design, conduct, and analysis of clinical trials in hospital-acquired pneumonia and ventilator-associated pneumoniaJohn 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....
- Salvage therapy trials in invasive fungal disease: challenges and opportunitiesJohn H Powers
Clin Infect Dis 43:1456-60. 2006
- Antimicrobial drug resistance, regulation, and researchJoshua 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...
- FDA evaluation of antimicrobials: subgroup analysisJohn H Powers
Chest 127:2298-9; authore reply 2300-1. 2005
- Anti-infective research and development--problems, challenges, and solutionsJohn S Bradley
Antimicrobial Availability Task Force of the Infectious Diseases Society of America, Alexandria, VA, USA
Lancet Infect Dis 7:68-78. 2007
- Correlation between bacteriologic and clinical endpoints in trials of acute otitis mediaRosemary Johann-Liang
Pediatr Infect Dis J 22:936-7; author reply 937. 2003
- Tubes and ear infectionsJohn H Powers
Pediatrics 113:178-9; author reply 178-9. 2004
- Trends in antimicrobial drug development: implications for the futureBrad 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...
- Itraconazole versus fluconazole for antifungal prophylaxisJohn H Powers
Ann Intern Med 140:580; author reply 581-2. 2004
- The United States Food and Drug Administration and noninferiority margins in clinical trials of antimicrobial agentsJohn H Powers
Clin Infect Dis 34:879-81. 2002
- Reassessing the design, conduct, and analysis of clinical trials of therapy for community-acquired pneumoniaJohn H Powers
Clin Infect Dis 46:1152-6. 2008
- Noninferiority and equivalence trials: deciphering 'similarity' of medical interventionsJohn 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
- Patient-reported outcomes to support medical product labeling claims: FDA perspectiveDonald 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....
- Increasing the efficiency of clinical trials of antimicrobials: the scientific basis of substantial evidence of effectiveness of drugsJohn 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....
- Diagnosis and treatment of acute otitis media: evaluating the evidenceJohn 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....
- Fluoroquinolone-resistant Campylobacter species and the withdrawal of fluoroquinolones from use in poultry: a public health success storyJennifer 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...
- Empirical antifungal therapy in febrile neutropenic patients: caution about composite end points and the perils of P valuesJohn H Powers
Clin Infect Dis 39:1738-9; author reply 1739. 2004
- Lipid amphotericin B formulations as comparators in clinical trialsJohn H Powers
Clin Infect Dis 38:305-6; author reply 306-7. 2004
- Evaluating combination therapy in community-acquired pneumoniaJohn H Powers
Chest 125:353. 2004
- Levofloxacin and macrolides for treatment of Legionnaires disease: multiple comparisons give few answersCarl N Kraus
Clin Infect Dis 41:416; author reply 416-7. 2005
- Sample size and the ethics of non-inferiority trialsJohn H Powers
Lancet 366:24-5. 2005
- Linezolid and vancomycin for methicillin-resistant Staphylococcus aureus nosocomial pneumonia: the subtleties of subgroup analysesJohn H Powers
Chest 126:314-5; author reply 315-6. 2004