Editorial commentary: Asking the right questions: Morbidity, mortality, and measuring what's important in unbiased evaluations of antimicrobials

Clinical Infectious Diseases

Volumn 54, Issue 12, 2012, Pages 1710-1713

  Powers, John H ^a,b,c  

^a SCIENCE APPLICATIONS INTERNATIONAL CORPORATION   (United States)

^b GEORGE WASHINGTON UNIVERSITY SCHOOL OF MEDICINE AND HEALTH SCIENCES   (United States)

^c UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIINFECTIVE AGENT; DAPTOMYCIN; DORIPENEM; TIGECYCLINE;

ANTIBIOTIC SENSITIVITY; CLINICAL RESEARCH; DIARRHEA; DRUG ACTIVITY; DRUG EFFICACY; DRUG INDUSTRY; DRUG SAFETY; DRUG SCREENING; HUMAN; META ANALYSIS (TOPIC); MINIMUM INHIBITORY CONCENTRATION; MORBIDITY; MORTALITY; NONHUMAN; NOTE; OUTCOME ASSESSMENT; PNEUMONIA; PRIORITY JOURNAL; STAPHYLOCOCCUS AUREUS; VENTILATOR ASSOCIATED PNEUMONIA;

ANTI-BACTERIAL AGENTS; HUMANS; MINOCYCLINE;

EID: 84861503205     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/cis274     Document Type: Note

References (27)

1. Prasad P, Sun J, Danner R, Natanson C. Excess deaths associated with tigecycline after approval based on non-inferiority trials. 2012; 54:1699-709.
2. US Food and Drug Administration. FDA Drug Safety Communication: increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections. US Food and Drug Administration. 1 September 2010. Available at: http://www. fda.gov/Drugs/DrugSafety/ucm224370.htm. Accessed 19 April 2012.
3. Cai Y, Wang R, Liang B, Bai N, Liu Y. Systematic review and meta-analysis of the effectiveness and safety of tigecycline for treatment of infectious disease. Antimicrob Agents Chemother 2011; 55:1162-72.
4. Tasina E, Haidich AB, Kokkali S, Arvanitidou M. Efficacy and safety of tigecycline for the treatment of infectious diseases: a metaanalysis. Lancet Infect Dis 2011; 11:834-44.
5. Yahav D, Lador A, Paul M, Leibovici L. Efficacy and safety of tigecycline: a systematic review and meta-analysis. J Antimicrob Chemother 2011; 66:1963-71.
6. Powers JH. Noninferiority and equivalence trials: deciphering 'similarity' of medical interventions. Stat Med 2008; 27:343-52. (Pubitemid 351227871)
7. Fritsche TR, Strabala PA, Sader HS, Dowzicky MJ, Jones RN. Activity of tigecycline tested against a global collection of Enterobacteriaceae, including tetracyclineresistant isolates. Diagn Microbiol Infect Dis 2005; 52:209-13. (Pubitemid 41133547)
8. Holmes NE, Turnidge JD, Munckhof WJ, et al. Antibiotic choice may not explain poorer outcomes in patients with Staphylococcus aureus bacteremia and high vancomycin minimum inhibitory concentrations. J Infect Dis 2011; 204:340-7.
9. Lambert ML, Suetens C, Savey A, et al. Clinical outcomes of health-care-associated infections and antimicrobial resistance in patients admitted to European intensive-care units: a cohort study. Lancet Infect Dis 2011; 11:30-8.
10. Martin SJ, Yost RJ. Infectious diseases in the critically ill patients. J Pharm Pract 2011; 24:35-43.
11. Dimasi JA. Risks in new drug development: approval success rates for investigational drugs. Clin Pharmacol Ther 2001; 69: 297-307.
12. Pertel PE, Bernardo P, Fogarty C, et al. Effects of prior effective therapy on the efficacy of daptomycin and ceftriaxone for the treatment of community-acquired pneumonia. Clin Infect Dis 2008; 46: 1142-51. (Pubitemid 351589895)
13. US Food and Drug Administration. FDA statement on recently terminated clinical trial with Doribax (doripenem). US Food and Drug Administration. 5 January 2012. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm285883.htm. Accessed 19 April 2012.
14. Fleming TR, Powers JH. Issues in noninferiority trials: the evidence in communityacquired pneumonia. Clin Infect Dis 2008; 47(suppl 3):S108-20.
15. Harris AD, Karchmer TB, Carmeli Y, Samore MH. Methodological principles of case-control studies that analyzed risk factors for antibiotic resistance: a systematic review. Clin Infect Dis 2001; 32:1055-61. (Pubitemid 32299641)
16. Lee DH, Vielemeyer O. Analysis of overall level of evidence behind Infectious Diseases Society of America practice guidelines. Arch Intern Med 2011; 171:18-22.
17. Powers JH. Practice guidelines: belief, criticism, and probability. Arch Intern Med 2011; 171: 15-7.
18. Powers JH, Fleming TR. Design, conduct, and analysis of clinical trials in disease due to methicillin-resistant Staphylococcus aureus. Clin Pharmacol Ther 2009; 86:244-7.
19. Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther 2001; 69:89-95.
20. Micheel CM, Ball JR. Evaluation of biomarkers and surrogate endpoints in chronic disease. Institute of Medicine. 12 May 2010. Available at: http://www.iom.edu/Reports/2010/Evaluationof-Biomarkers-and-Surrogate-Endpoints- in-Chronic-Disease.aspx. Accessed 19 April 2012.
21. Patrick DL, Burke LB, Gwaltney CJ, et al. Content validity-establishing and reporting the evidence in newly developed patientreported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 2-assessing respondent understanding. Value Health 2011; 14:978-88.
22. Patrick DL, Burke LB, Gwaltney CJ, et al. Content validity-establishing and reporting the evidence in newly developed patientreported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1-eliciting concepts for a new PRO instrument. Value Health 2011; 14:967-77.
23. Powers JH. Recommendations for improving the design, conduct, and analysis of clinical trials in hospital-acquired pneumonia and ventilator-associated pneumonia. Clin Infect Dis 2010; 51,suppl. 1:S18-28.
24. Sorbello A, Komo S, Valappil T, Nambiar S. Registration trials of antibacterial drugs for the treatment of nosocomial pneumonia. Clin Infect Dis 2010; 51, suppl. 1:S36-41.
25. Foundation for the National Institutes of Health. Request for proposals for developing endpoints for clinical trials for the treatment of acute bacterial skin and skin structure infections. Foundation for the National Institutes of Health. 6 January 2012. Available at: http://www.fnih.org/press/ blog/request-proposalsrfp-developing-endpoints-clinical-trials-drugstreatment- acute. Accessed 19 April 2012.
26. Freedman B. Scientific value and validity as ethical requirements for research: a proposed explication. IRB 1987; 9:7-10.
27. US District Court of Delaware. Pharmaceutical Manufacturers of America vs Richardson. 20 October 1970. Report No.: 318 F. Supp 301.