Rapid Assessment of Acute Illness and Injury to Enhance UK Response to Public Health

STATEMENT OF WORK Peter E. Morris, MD University of Kentucky Peter E. Morris will be the site PI for University of Kentucky. Dr. Morris will assist with creation of the dataset that will be used to collect information for the project, leveraging his previous work with USCIITG PREP. Dr. Morris also will collaborate with the other USCIITG sites and well as the project PI, Dr. Cobb, for any additional work that will be done through the project. Brief summary: The overarching goal of this 5-year FDA award is to develop and implement strategies to assess, evaluate, and monitor medical countermeasure safety, performance, and patient compliance in response to a public health emergency. Clinical sites for the United States Critical Illness and Injury Trials Group Program for Emergency Preparedness (USCllTG-PREP) have been recruited to perform this work. The work is divided into a Base Period and 4 one-year Option Periods. Base Period (years 1-4): There are four deliverables identified for the base period: • In year 1, develop an intravenous antiviral treatment protocol to assess the use of intravenous (IV) antivirals (e.g., IV zanamivir) under an expanded access IND for critically ill patients with confirmed influenza using electronic case report forms (eCRFs) and a data entry user manual. • Utilize pre-established infrastructure for broad coverage of clinical trial sites across the United States • Utilize rapid data collection tool/mechanism for collection of safety (adverse events) and effectiveness (performance) data • Collaborate with BARDA and BARDA-funded company sponsors of medical countermeasures on pathway for FDA approval/licensure under the Animal Rule to meet post-marketing regulatory commitments The bulk of this work will be accomplished in Year 1 of the Base Period; minor iterations of the work are required annually thereafter. Collaborators in the USCllTG-PREP network are tasked with coordinating reports and completing the work required at their respective sites.