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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.

Publication ,  Journal Article
Knirsch, C; Alemayehu, D; Botgros, R; Comic-Savic, S; Friedland, D; Holland, TL; Merchant, K; Noel, GJ; Pelfrene, E; Reith, C; Santiago, J ...
Published in: Clin Infect Dis
August 15, 2016

BACKGROUND: The etiology of hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP) is often multidrug-resistant infections. The evaluation of new antibacterial drugs for efficacy in this population is important, as many antibacterial drugs have demonstrated limitations when studied in this population. HABP/VABP trials are expensive and challenging to conduct due to protocol complexity and low patient enrollment, among other factors. The Clinical Trials Transformation Initiative (CTTI) seeks to advance antibacterial drug development by streamlining HABP/VABP clinical trials to improve efficiency and feasibility while maintaining ethical rigor, patient safety, information value, and scientific validity. METHODS: In 2013, CTTI engaged a multidisciplinary group of experts to discuss challenges impeding the conduct of HABP/VABP trials. Separate workstreams identified challenges associated with HABP/VABP protocol complexity. The Project Team developed potential solutions to streamline HABP/VABP trials using a Quality by Design approach. RESULTS: CTTI recommendations focus on 4 key areas to improve HABP/VABP trials: informed consent processes/practices, protocol design, choice of an institutional review board (IRB), and trial outcomes. Informed consent processes should include legally authorized representatives. Protocol design decisions should focus on eligibility criteria, prestudy antibacterial therapy considerations, use of new diagnostics, and sample size. CTTI recommends that sponsors use a central IRB and discuss trial endpoints with regulators, including defining a clinical failure and evaluating the impact of concomitant antibacterial drugs. CONCLUSIONS: Streamlining HABP/VABP trials by addressing key protocol elements can improve trial startup and patient recruitment/retention, reduce trial complexity and costs, and ensure patient safety while advancing antibacterial drug development.

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Published In

Clin Infect Dis

DOI

EISSN

1537-6591

Publication Date

August 15, 2016

Volume

63 Suppl 2

Start / End Page

S29 / S36

Location

United States

Related Subject Headings

  • Universities
  • United States Food and Drug Administration
  • United States
  • Treatment Outcome
  • Public-Private Sector Partnerships
  • Pneumonia, Ventilator-Associated
  • Pneumonia, Bacterial
  • Patient Safety
  • Microbiology
  • Humans
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Knirsch, Charles, Demissie Alemayehu, Radu Botgros, Sabrina Comic-Savic, David Friedland, Thomas L. Holland, Kunal Merchant, et al. “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.Clin Infect Dis 63 Suppl 2 (August 15, 2016): S29–36. https://doi.org/10.1093/cid/ciw258.
Knirsch C, Alemayehu D, Botgros R, Comic-Savic S, Friedland D, Holland TL, Merchant K, Noel GJ, Pelfrene E, Reith C, Santiago J, Tiernan R, Tenearts P, Goldsack JC, Fowler VG. 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. Clin Infect Dis. 2016 Aug 15;63 Suppl 2:S29–S36.
Journal cover image

Published In

Clin Infect Dis

DOI

EISSN

1537-6591

Publication Date

August 15, 2016

Volume

63 Suppl 2

Start / End Page

S29 / S36

Location

United States

Related Subject Headings

  • Universities
  • United States Food and Drug Administration
  • United States
  • Treatment Outcome
  • Public-Private Sector Partnerships
  • Pneumonia, Ventilator-Associated
  • Pneumonia, Bacterial
  • Patient Safety
  • Microbiology
  • Humans