title: 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.
abstract: BACKGROUND
  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.
  
  
  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 current data collection processes. Experts defined "data collection" as the act of capturing and reporting certain data on the case report form as opposed to recording of data as part of routine clinical care. The ABDD Project Team developed strategies for streamlining safety data collection in HABP/VABP trials using a Quality by Design approach.
  
  
  RESULTS
  Current safety data collection processes in HABP/VABP trials often include extraneous information. More targeted strategies for safety data collection in HABP/VABP trials will rely on optimal protocol design and prespecification of which safety data are essential to satisfy regulatory reporting requirements.
  
  
  CONCLUSIONS
  A consensus and a cultural change in clinical trial design and conduct, which involve recognition of the need for more efficient data collection, are urgently needed to advance ABDD and to improve HABP/VABP trials in particular.
authors.affiliation: Northwestern University Feinberg School of Medicine, Chicago, Illinois.
authors.forename: Helen
authors.initials: H
authors.lastname: Donnelly
authors.affiliation: Pfizer, Inc, New York, New York.
authors.forename: Demissie
authors.initials: D
authors.lastname: Alemayehu
authors.affiliation: Office of Anti-infectives and Vaccines, European Medicines Agency, London, United Kingdom.
authors.forename: Radu
authors.initials: R
authors.lastname: Botgros
authors.affiliation: The Medicines Company, Parsippany.
authors.forename: Sabrina
authors.initials: S
authors.lastname: Comic-Savic
authors.affiliation: Merck & Co, Inc, Kenilworth, New Jersey.
authors.forename: Barry
authors.initials: B
authors.lastname: Eisenstein
authors.affiliation: Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Lorenz
authors.affiliation: RRD International, LLC, Rockville, Maryland.
authors.forename: Kunal
authors.initials: K
authors.lastname: Merchant
authors.affiliation: Office of Anti-infectives and Vaccines, European Medicines Agency, London, United Kingdom.
authors.forename: Eric
authors.initials: E
authors.lastname: Pelfrene
authors.affiliation: University of Oxford, United Kingdom.
authors.forename: Christina
authors.initials: C
authors.lastname: Reith
authors.affiliation: Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring.
authors.forename: Jonas
authors.initials: J
authors.lastname: Santiago
authors.affiliation: Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring.
authors.forename: Rosemary
authors.initials: R
authors.lastname: Tiernan
authors.affiliation: Northwestern University Feinberg School of Medicine, Chicago, Illinois.
authors.forename: Richard
authors.initials: R
authors.lastname: Wunderink
authors.affiliation: Clinical Trials Transformation Initiative, Durham, North Carolina.
authors.forename: Pamela
authors.initials: P
authors.lastname: Tenaerts
authors.affiliation: Pfizer, Inc, Pearl River, New York.
authors.forename: Charles
authors.initials: C
authors.lastname: Knirsch
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods*; D003625:Data Collection / Q000379:methods*; D006801:Humans; D061214:Patient Safety; D018410:Pneumonia, Bacterial / Q000188:drug therapy*; D053717:Pneumonia, Ventilator-Associated / Q000188:drug therapy*; D055818:Public-Private Sector Partnerships; D016896:Treatment Outcome; D014481:United States
chemical_list: D000900:Anti-Bacterial Agents
keywords: CTTI; clinical trials; data collection; hospital-acquired bacterial pneumonia; ventilator-associated bacterial pneumonia