Challenges in HABP/VABP trials and potential solutions
Sponsored by: Covance
Date: 29 May
Days to go: 3
Time: 4PM London/11AM New York
Running a trial to test new antimicrobials for Hospital-Acquired Bacterial Pneumonia and Ventilator-Acquired Bacterial Pneumonia (HABP/VABP) is extremely challenging for sponsors and sites. Each site must have robust methods in place to accurately identify and diagnose a potential trial participant, obtain informed consent, complete screening and start the trial’s treatment regime – before the standard of care treatment is administered to address the life-threatening condition.
From the study design perspective, a HABP/VABP trial is complex given that participants may have underlying diseases or other infections that may have contributed to the nosocomial pneumonia. Furthermore, regulatory agencies do not completely align on study endpoints, which can complicate the design of a global study.
Despite the challenges faced, sponsors and sites can apply several strategies to improve the design and conduct of HABP/VABP trials. Join this webinar to learn more about trends, epidemiology, trial design and study endpoints along with clinical approaches and data collection considerations. From the recruitment and enrollment perspective, you’ll learn about patient identification methods, ethical issues with informed consent, steps to reduce screen failure and the emerging role of molecular diagnostics. Please register today.
Patrick McLeroth, MD,
Executive Medical Director, iiGM
Dr. McLeroth joined Covance as medical director of infectious Disease in July 2008 and is based in the Princeton, NJ office. Prior to joining Covance, he worked at Chase Brexton Health Services, Inc. in Baltimore, MD, as director of HIV Medicine and Research, and was principal investigator on over 30 clinical trials between 2002 and 2008. Since 2008 he has worked as the global lead medical monitor on multiple protocols covering all aspects of infectious disease, with specific experience in critical care and HABP/VABP. He was promoted to senior medical director in 2011, and executive medical director in 2013.
Dr. McLeroth completed his fellowship in Infectious Disease and his residency in Internal Medicine at St. Luke's-Roosevelt Hospital in New York City. He completed his MBBCh degree at the University of the Witwatrersrand in South Africa in 1995, and his internship at the Baragwanath-Chris Hani Memorial Hospital in Johannesburg in 1996.
Ignacio Martin-Loeches, PhD, JFICMI,
Consultant in Intensive Care Medicine and Senior Clinical Lecturer & Research Director of the Multidisciplinary Intensive Care Research Organization (MICRO) at Trinity College, Dublin
Dr. Martin-Loeches is currently vicechair of Intensive Care Medicine at St James’s University Hospital, Dublin. He has served as executive member for the European Diploma in Intensive Care (EDIC) and as deputy for the Sepsis and Infection Section at the European Society of Intensive Care Medicine (ESICM). He is the chair of the Severe Sepsis and Septic Shock Working Group “4SWG” and executive member of the research-working group of the Surviving Sepsis Campaign (SSC). He is the currently member of the Clinical Trials of Health Research Board in Ireland and the president of the Spanish Research Society of Ireland under the Embassy of Spain in Ireland and The Spanish Foundation for Science and Technology (FECYT).
He is principal Investigator of European Regional Development Funds (ERDF) grant and the European Network for ICU-related respiratory infections (ENIRRIs) under the European Respiratory Society (ERS). He has published several manuscripts in high impact factor journal and serves as section editor at the Intensive Care Medicine (ICM) journal. Dr Martin-Loeches' areas of expertise include sepsis, pneumonia and respiratory failure in critically ill patients.
Key Learning Objectives
- Understand recent trends and epidemiology in HABP/VABP
- Gain insights on trial design and clinical end points
- Learn about challenges with patient identification and high screen failure rates
- Hear about strategies for improving diagnosis and managing clinical data volumes
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