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 | Zendy

Helen K. Donnelly | Zendy; Demissie Alemayehu | Zendy; Radu Botgros | Zendy; Sabrina Comic-Savic | Zendy; Barry I. Eisenstein | Zendy; Benjamin D. Lorenz | Zendy; Kunal Merchant | Zendy; Eric Pelfrene | Zendy; Christina Reith | Zendy; Jonas Santiago | Zendy; Rosemary Tiernan | Zendy; Richard G. Wunderink | Zendy; Pamela Tenaerts | Zendy; Charles Knirsch | Zendy

Open Access

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

Author(s) -

Helen K. Donnelly,

Demissie Alemayehu,

Radu Botgros,

Sabrina Comic-Savic,

Barry I. Eisenstein,

Benjamin D. Lorenz,

Kunal Merchant,

Eric Pelfrene,

Christina Reith,

Jonas Santiago,

Rosemary Tiernan,

Richard G. Wunderink,

Pamela Tenaerts,

Charles Knirsch

Publication year - 2016

Publication title -

clinical infectious diseases

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 3.44

H-Index - 336

eISSN - 1537-6591

pISSN - 1058-4838

DOI - 10.1093/cid/ciw316

Subject(s) - clinical trial , medicine , data collection , patient safety , data quality , protocol (science) , intensive care medicine , drug development , ventilator associated pneumonia , health care , pharmacology , alternative medicine , drug , operations management , pathology , engineering , intensive care unit , metric (unit) , statistics , mathematics , economics , economic growth

Resistant bacteria are one of the leading causes of hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP). HABP/VABP trials are complex and difficult to conduct due to the large number of medical procedures, adverse events, and concomitant medications involved. Differences in the legislative frameworks between different regions of the world may also lead to excessive data collection. The Clinical Trials Transformation Initiative (CTTI) seeks to advance antibacterial drug development (ABDD) by streamlining clinical trials to improve efficiency and feasibility while maintaining ethical rigor, patient safety, information value, and scientific validity.

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