FDA selects Icon to work on PRO measures for pneumonia trials
Thursday, November 6, 2014
Global CRO Icon, based in Dublin, has been awarded a project by the FDA to develop an industry-standard Patient Reported Outcome (PRO) measure that can be used in anti-bacterial drug development trials for hospital-acquired bacterial pneumonia (HABP).
HABP is the second most common hospital-acquired infection and is the primary cause of death in intensive care units. Icon’s commercialization and outcomes group, in collaboration with the Biomarkers Consortium of the Foundation for the National Institutes of Health (FNIH), aims to address an unmet need for a well-defined, reliable endpoint that can measure the effects of antibacterial drugs on HABP patients. The project involves creating a HABP PRO instrument with established content validity in accordance with the FDA Drug Development Tool qualification process. The new PRO would assess the symptoms of HABP at various time points over the course of the infection.
The collaboration brings together scientists from Icon, the FDA, the National Institute of Allergy and Infectious Diseases, the Infectious Diseases Society of America, pharma and biotech companies and the academic research community to develop new approaches to evaluating the efficacy of antibiotics in future clinical trials of therapies for HABP.