Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team

Clinical Infectious Diseases

Volumn 63, Issue , 2016, Pages S29-S36

  Knirsch, Charles ^a   Alemayehu, Demissie ^a   Botgros, Radu ^b   Comic Savic, Sabrina ^c   Friedland, David ^d   Holland, Thomas L ^e   Merchant, Kunal ^f   Noel, Gary J ^g   Pelfrene, Eric ^b   Reith, Christina ^h   Santiago, Jonas ⁱ   Tiernan, Rosemary ⁱ   Tenearts, Pamela ^j   Goldsack, Jennifer C ^j   Fowler, Vance G ^e  

^a PFIZER INC   (United States)

^b EUROPEAN MEDICINES AGENCY   (United Kingdom)

^c Medicines Company   (United States)

^d Wockhardt USA   (United States)

^e DUKE UNIVERSITY   (United States)

^f RRD International   (United States)

^g JOHNSON AND JOHNSON   (United States)

^h UNIVERSITY OF OXFORD   (United Kingdom)

ⁱ CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^j Clinical Trials Transformation Initiative (CTTI)   (United States)

more..

Author keywords

clinical trials; CTTI; Hospital Acquired bacterial pneumonia; protocol development; ventilator associated bacterial pneumonia

Indexed keywords

ANTIINFECTIVE AGENT;

ANTIBIOTIC THERAPY; ARTICLE; BACTERIAL PNEUMONIA; CLINICAL TRIAL (TOPIC); CONTROLLED STUDY; DECISION MAKING; DRUG EFFICACY; HOSPITAL ACQUIRED PNEUMONIA; HUMAN; INFORMED CONSENT; MEDICAL ETHICS; MULTICENTER STUDY (TOPIC); PATIENT SAFETY; PRIORITY JOURNAL; PROGRAM FEASIBILITY; RANDOMIZED CONTROLLED TRIAL; VENTILATOR ASSOCIATED PNEUMONIA; DRUG INDUSTRY; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; PRACTICE GUIDELINE; PROCEDURES; PUBLIC-PRIVATE PARTNERSHIP; TREATMENT OUTCOME; UNITED STATES; UNIVERSITY;

ANTI-BACTERIAL AGENTS; CLINICAL TRIALS AS TOPIC; DRUG EVALUATION; DRUG INDUSTRY; HUMANS; PATIENT SAFETY; PNEUMONIA, BACTERIAL; PNEUMONIA, VENTILATOR-ASSOCIATED; PUBLIC-PRIVATE SECTOR PARTNERSHIPS; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; UNIVERSITIES;

EID: 85010876809     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/ciw258     Document Type: Article

References (46)

1. Centers for Disease Control and Prevention. Antibiotic resistance threats in the United States, 2013. Atlanta, GA: Centers for Disease Control and Prevention, 2013.
2. Sievert DM, Ricks P, Edwards JR, et al. Antimicrobial-resistant pathogens associated with healthcare-associated infections: summary of data reported to the National Healthcare Safety Network at the Centers for Disease Control and Prevention, 2009-2010. Infect Control Hosp Epidemiol 2013; 34:1-14.
3. Rosenthal VD, Maki DG, Jamulitrat S, et al. International Nosocomial Infection Control Consortium (INICC) report, data summary for 2003-2008, issued June 2009. Am J Infect Control 2010; 38:95-104. e2.
4. Innovative Medicines Initiative. New drugs for bad bugs. Available at: http://www.imi.europa.eu/content/nd4bb. Accessed 17 December 2015.
5. Centers for Disease Control and Prevention. Detect and protect against antibiotic resistance. Available at: http://www.cdc.gov/drugresistance/detect-and-protect/. Accessed 17 December 2015.
6. Infectious Diseases Society of America. Antibiotic development: The 10 x '20 initiative. Available at: http://www.idsociety.org/10x20/. Accessed 17 December 2015.
7. Woodcock J. Three encouraging steps towards new antibiotics. Available at: http://blogs.fda.gov/fdavoice/index.php/tag/gain-act/. Accessed 17 December 2015.
8. Barriere SL. Challenges in the design and conduct of clinical trials for hospitalacquired pneumonia and ventilator-associated pneumonia: an industry perspective. Clin Infect Dis 2010; 51(suppl 1):S4-9.
9. Stergiopoulos S, Tenaerts P, Getz K. Cost drivers of a hospital acquired bacterial pneumonia and ventilator acquired bacterial pneumonia (HABP/VABP) phase three clinical trials. In: IDWeek 2015, San Diego, CA, 2015.
10. Clinical Trials Transformation Initiative. Streamlining HABP/VABP trials: project summary. Available at: http://www.ctti-clinicaltrials.org/what-we-do/ctti-projects/habpvabp-trials. Accessed 1 December 2015.
11. Clinical Trials Transformation Initiative. AB drug development. Available at: http://www.ctti-clinicaltrials.org/what-we-do/ctti-project-categories/ab-drugdevelopment. Accessed 1 December 2015.
12. Knirsch C, Alemayehu D, Botgros R, et al. Streamlining safety data collection in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia trials: recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project team. Clin Infect Dis 2016; 63(suppl 2): S29-36.
13. Clinical Trials Transformation Initiative Antibacterial Drug Development HABP/VABPWorking Group; Behm M, Comic-Savic S, et al. A collaboration to facilitate the development of antibacterial agents for unmet need: streamlining clinical trial protocols. In: Develop, Innovate, Advance (DIA) 50th Annual Meeting, San Diego, CA, 2014.
14. Clinical Trials Transformation Initiative. QbD: project summary. Available at: http://www.ctti-clinicaltrials.org/what-we-do/investigational-plan/qbd-qrm. Accessed 1 December 2015.
15. Clinical Trials Transformation Initiative. CTTI recommendations: quality by design. Available at: http://www.ctti-clinicaltrials.org/files/QbD-toolkit/CTTI% 20Quality%20by%20Design%20Recommendations-FINAL-1JUN15.pdf. Accessed 1 December 2015.
16. Clinical Trials Transformation Initiative. Informed consent: project summary. Available at: http://www.ctti-clinicaltrials.org/what-we-do/study-start-up/informed-consent. Accessed 1 December 2015.
17. US Department of Health and Human Services. Frequently asked questions: who can be a legally authorized representative (LAR) for the purpose of providing consent on behalf of a prospective subject? Available at: http://www.hhs.gov/ohrp/policy/faq/informed-consent/legally-authorized-representative-for-providingconsent. html. Accessed 1 December 2015.
18. Food and Drug Administration. General requirements for informed consent. Vol 45 CFR §46.116.
19. Food and Drug Administration. Definitions. Vol 45 CRF §46.102(c).
20. Clinical Trials Transformation Initiative. CTTI recommendations: informed consent. Available at: http://www.ctti-clinicaltrials.org/files/Informed-Consent/CTTIInformedConsent-Recs.pdf. Accessed 8 February 2016.
21. European Medicines Agency. Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. London: EMA, 2013.
22. European Medicines Agency Committee for Medicinal Products for Human Use. Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. London: EMA, 2011.
23. Food and Drug Administration. Guidance for industry hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia: developing drugs for treatment (draft guidance, revision 2). Rockville, MD: FDA, 2014.
24. Spellberg B, Talbot G. Recommended design features of future clinical trials of antibacterial agents for hospital-acquired bacterial pneumonia and ventilatorassociated bacterial pneumonia. Clin Infect Dis 2010; 51(suppl 1):S150-70.
25. European Medicines Agency Committee for Medicinal Products for Human Use. Guideline on adjustment for baseline covariates in clinical trials. London: EMA, 2015.
26. Craven D. Ventilator-associated pneumonia (VAP) hospital-acquired pneumonia (HAP) definitions, diagnostics and outcomes. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM281977.pdf. Accessed 3 February 2016.
27. Food and Drug Administration. Anti-infective Drugs Advisory Committee meeting announcement, 2011. Available at: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm273363.htm. Accessed 3 February 2016.
28. Infectious Diseases Society of America. Re: comments on docket #FDA-2010-D-0589; draft guidance for industry on hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP): developing drugs for treatment; 75 Federal Register 73107; 29 November 2010. Available at: http://www.idsociety.org/uploadedFiles/IDSA/Policy-and-Advocacy/Current-Topics-and-Issues/Advancing-Product-Research-and-Development/Bad-Bugs-No-Drugs/Position-Papers/IDSA%20Comments%20on%20HABP% 20and%20VABP.pdf. Accessed 28 December 2015.
29. 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.
30. Rubinstein E, Cammarata S, Oliphant T, Wunderink R; Linezolid Nosocomial Pneumonia Study Group. Linezolid (PNU-100766) versus vancomycin in the treatment of hospitalized patients with nosocomial pneumonia: a randomized, double-blind, multicenter study. Clin Infect Dis 2001; 32:402-12.
31. Baron EJ, Miller JM, Weinstein MP, et al. A guide to utilization of the microbiology laboratory for diagnosis of infectious diseases: 2013 recommendations by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM)). Clin Infect Dis 2013; 57:e22-121.
32. Projan SJ. Why is big pharma getting out of antibacterial drug discovery? Curr Opin Microbiol 2003; 6:427-30.
33. Spellberg B. The future of antibiotics. Crit Care 2014; 18:228.
34. Office of the Press Secretary. Fact sheet: Obama administration takes actions to combat antibiotic-resistant bacteria. Available at: https://www.whitehouse.gov/the-press-office/2014/09/18/fact-sheet-obama-administration-takes-actionscombat-antibiotic-resistan. Accessed 6 October 2015.
35. European Medicines Agency. Points to consider on application with 1. Meta-analyses; 2. One pivotal study. London: EMA, 2001.
36. Menikoff J. The paradoxical problem with multiple-IRB review. New Engl J Med 2010; 363:1591-3.
37. Wagner TH, Murray C, Goldberg J, Adler JM, Abrams J. Costs and benefits of the national cancer institute central institutional review board. J Clin Oncol 2010; 28:662-6.
38. Check DK, Weinfurt KP, Dombeck CB, Kramer JM, Flynn KE. Use of central institutional review boards for multicenter clinical trials in the United States: a review of the literature. Clin Trials 2013; 10:560-7.
39. Clinical Trials Transformation Initiative. Considerations to support communication between institutions and outside IRBs when responsibilities are being assigned for multi-center clinical trial protocols. Available at: http://www.ctticlinicaltrials. org/files/Central-IRB/Considerations%20Document%20-%20Use% 20of%20Central%20IRBs%20for%20Multicenter%20Clinical%20Trials%20NB2web. pdf. Accessed 1 December 2015.
40. Flynn KE, Hahn CL, Kramer JM, et al. Using central IRBs for multicenter clinical trials in the United States. PLoS One 2013; 8:e54999.
41. Food and Drug Administration. Guidance for industry: using a centralized IRB review process in multicenter clinical trials. Rockville, MD: FDA, 2006.
42. Clinical Trials Transformation Initiative. Antibacterial drug development program update: summary of working group webinar held 29 August 2013. Available at: http://www.ctti-clinicaltrials.org/files/ABDD/ABDD-29Aug13%20-%20Working %20Group%20meeting%20summary%20with%20cover-final.pdf. Accessed 4 May 2016.
43. American Thoracic Society, Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, healthcareassociated pneumonia. Am J Respir Crit Care Med 2005; 171:388-416.
44. Food and Drug Administration. Guidance for industry: non-inferiority clinical trials draft guidance. Silver Spring, MD: FDA, 2010.
45. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline: statistical principles for clinical trials E9, 5 February 1998. Available at: http://www.fda.gov/ohrms/dockets/ac/02/briefing/3837b1-03-ICH%20e9.pdf. Accessed 5 May 2016.
46. Toerner JG, Burke L, Komo S, Papadopoulos E. A collaborative model for endpoint development for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. Clin Infect Dis 2012; 55:1122-3.