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WEBINAR: Challenges in HABP/VABP trials and potential solutions

May 29, 2019

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.