ICON Selected by the FDA to Develop New PRO Measure for HABP Trials
ICON plc has announced that it has been awarded a project by the US Food & Drug Administration (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, pharmaceutical and biotechnology companies, and the academic research community to develop new approaches to evaluating the efficacy of antibiotics in future clinical trials of therapies for HABP.
“We are proud to be working with FDA and the FNIH to develop a PRO measure that will enable a better understanding of the effects of anti-bacterial drugs on HABP patients,” commented Elizabeth Thiele, President, ICON Commercialization & Outcomes. “This project is particularly important given the need for new medicines to treat emerging drug-resistant strains of HABP pathogens which are on the increase. ICON’s PRO group offers the right blend of knowledge and industry expertise in all areas of outcomes research to develop a reliable endpoint for HABP trials which will help deliver new antibacterial drugs to patients faster.”