Noninferior antibiotics: When is "not bad" "good enough"?

Open Forum Infectious Diseases

Volumn 3, Issue 3, 2016, Pages

  DiNubile, Mark J ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Antibiotic resistance; Confidence intervals; Noninferiority trials

Indexed keywords

ANTIBIOTIC AGENT;

ANTIBIOTIC RESISTANCE; ARTICLE; COMMUNITY ACQUIRED INFECTION; HOSPITAL; HOSPITAL PATIENT; HUMAN; MORBIDITY; MORTALITY; MULTIDRUG RESISTANCE; NULL HYPOTHESIS; NURSING HOME; PRIORITY JOURNAL;

EID: 85015835459     PISSN: None     EISSN: 23288957     Source Type: Journal    
DOI: 10.1093/ofid/ofw110     Document Type: Article

References (25)

1. Gilbert D, Guidos R, Boucher H, et al, for the Infectious Diseases Society of America. The 10 × 20 initiative: pursuing a global commitment to develop 10 new antibacterial drugs by 2020. Clin Infect Dis 2010; 50:1081-3.
2. Rex JH, Eisenstein BI, Alder J, et al. A comprehensive regulatory framework to address the unmet need for new antibacterial treatments. Lancet Infect Dis 2013; 13:269-75.
3. Lewis K. Challenges of antibiotic discovery. Microbe 2015; 10:363-9.
4. Piddock LJ. The crisis of no new antibiotics-what is the way forward? Lancet Infect Dis 2012; 12:249-53.
5. Harbarth S, Theuretzbacher U, Hackett J; DRIVE-AB consortium. Antibiotic research and development: business as usual? J Antimicrob Chemother 2015; 70:1604-7.
6. Doshi P. Speeding new antibiotics to market: a fake fix? BMJ 2015; 350:h1453.
7. Spellberg B, Brass E, Bradley J, et al, for the Infectious Diseases Society of America. White paper: recommendations on the conduct of superiority and organismspecific clinical trials of antibacterial agents for the treatment of infections caused by drug-resistant bacterial pathogens. Clin Infect Dis 2012; 55:1031-46.
8. Kaji AH, Lewis RJ. Noninferiority trials: is a new treatment almost as effective as another? JAMA 2015; 313:2371-2.
9. DiNubile MJ, Sklar P, Lupinacci RJ, Eron J. Paradoxical interpretation of non-inferiority studies. Future Virol 2012; 7:1055-63.
10. Deak D, Outterson K, Powers JH, Kesselheim AS. Progress in the fight against multidrug-resistant bacteria? A review of U.S. Food and Drug Administrationapproved antibiotics, 2010-2015 [Epub ahead of print 31 May 2016]. Ann Intern Med 2016; doi: 10.7326/M16-0291.
11. Freidlin B, Korn EL, George SL, Gray R. Randomized clinical trial design for assessing noninferiority when superiority is expected. J Clin Oncol 2007; 25:5019-23.
12. Newgard CD, Lewis RJ. Missing data: how to best account for what is not known. JAMA 2015; 314:940-1.
13. Kaul S, Diamond GA. Good enough: a primer on the analysis and interpretation of noninferiority trials. Ann Intern Med 2006; 145:62-9.
14. Tuma RS. Trend toward noninferiority trials may mean more difficult interpretation of trial results. J Natl Cancer Inst 2007; 99:1746-8.
15. Fleming TR, Powers JH. Issues in noninferiority trials: the evidence in community-acquired pneumonia. Clin Infect Dis 2008; 47(Suppl 3):S108-20.
16. Powers JH, Ross DB, Brittain E, et al. The United States Food and Drug Administration and noninferiority margins in clinical trials of antimicrobial agents. Clin Infect Dis 2002; 34:879-81.
17. Shlaes DM, Moellering RC Jr. The United States Food and Drug Administration and the end of antibiotics. Clin Infect Dis 2002; 34:420-2.
18. Spellberg B, Talbot GH, Boucher HW, et al. Antimicrobial agents for complicated skin and skin-structure infections: justification of noninferiority margins in the absence of placebo-controlled trials. Clin Infect Dis 2009; 49:383-91.
19. Prasad P, Sun J, Danner RL, Natanson C. Excess deaths associated with tigecycline after approval based on noninferiority trials. Clin Infect Dis 2012; 54:1699-709.
20. Evans SR, Rubin D, Follmann D, et al. Desirability of outcome ranking (DOOR) and response adjusted for duration of antibiotic risk (RADAR). Clin Infect Dis 2015; 61:800-6.
21. Le HenanffA, Giraudeau B, Baron G, Ravaud P. Quality of reporting of noninferiority and equivalence randomized trials. JAMA 2006; 295:1147-51.
22. Reboli AC, Rotstein C, Pappas PG, et al. Anidulafungin versus fluconazole for invasive candidiasis. N Engl J Med 2007; 356:2472-82.
23. Braitman LE. Confidence intervals assess both clinical significance and statistical significance. Ann Intern Med 1991; 114:515-7.
24. Eron JJ, Young B, Cooper DA, et al. Switch to a raltegravir-based regimen versus continuation of a lopinavir-ritonavir-based regimen in stable HIV-infected patients with suppressed viraemia (SWITCHMRK 1 and 2): two multicentre, double-blind, randomised controlled trials. Lancet 2010; 375:396-407.
25. Podolsky SH, Powers JH III. Regulating antibiotics in an era of resistance: The historical basis and continued need for adequate and well-controlled investigations. Ann Intern Med 2015; 163:386-8.