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

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

doi:10.1093/cid/ciw316

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 Aug 15:63 Suppl 2:S39-45. doi: 10.1093/cid/ciw316.

Authors

Affiliations

¹ Northwestern University Feinberg School of Medicine, Chicago, Illinois.
² Pfizer, Inc, New York, New York.
³ Office of Anti-infectives and Vaccines, European Medicines Agency, London, United Kingdom.
⁴ The Medicines Company, Parsippany.
⁵ Merck & Co, Inc, Kenilworth, New Jersey.
⁶ Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring.
⁷ RRD International, LLC, Rockville, Maryland.
⁸ University of Oxford, United Kingdom.
⁹ Clinical Trials Transformation Initiative, Durham, North Carolina.
¹⁰ Pfizer, Inc, Pearl River, New York.

PMID: 27481952
DOI: 10.1093/cid/ciw316

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.

Keywords: CTTI; clinical trials; data collection; hospital-acquired bacterial pneumonia; ventilator-associated bacterial pneumonia.

Publication types

Practice Guideline

MeSH terms

Anti-Bacterial Agents / therapeutic use*
Clinical Trials as Topic / methods*
Data Collection / methods*
Humans
Patient Safety
Pneumonia, Bacterial / drug therapy*
Pneumonia, Ventilator-Associated / drug therapy*
Public-Private Sector Partnerships*
Treatment Outcome
United States

Substances

Anti-Bacterial Agents