ICON has been awarded a project by the US Food & Drug Administration (FDA) to validate three Patient Reported Outcomes (PRO) instruments that will measure clinical endpoints in antibacterial drug trials. The conditions in which the endpoints will be validated are Acute Bacterial Skin and Skin Structure Infections (ABSSSI), Community-Acquired Bacterial Pneumonia (CABP) and 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; ABSSSI has high rates of morbidity and other associated medical conditions whilst CABP is a major cause of mortality and morbidity worldwide, particularly among people over 65 years of age. Sponsors engaged in clinical trials for these conditions are currently using different methodologies to assess the primary endpoint as there is no qualified PRO instrument.
ICON’s Clinical Outcomes Assessment (COA) group, in collaboration with the Biomarkers Consortium of the Foundation for the National Institutes of Health (FNIH), will create an electronic platform to validate key PROs, allowing investigators to assess the symptoms of ABSSSI, CABP and HABP at various time points over the course of the infection and measure the effects of antibacterial drugs. The PROs will be implemented on CRF Health’s TrialMax® eCOA platform, allowing patients to use the application on a handheld device during the course of the trials. These PROs will continue to be validated and developed in accordance with the FDA guidance for PRO measures used to support labeling claims and will follow the Drug Development Tool (DDT) Qualification Program.
The collaboration brings together scientists from ICON, FNIH, 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 for evaluating the efficacy of antibiotics in future clinical trials of therapies for ABSSSI, CABP and HABP.
“This project builds on our previous work with the FDA and FNIH to develop a new PRO measure for HABP trials and we’re proud to continue our support in this area of great unmet need,” commented Ramita Tandon, Executive Vice President, ICON Commercialisation & Outcomes. “Bacterial infections are becoming harder to treat as drug-resistant strains emerge at an increasing rate. ICON’s COA group has extensive experience in all areas of outcomes research to validate these important endpoints for antibacterial trials, speeding up the drug development process and delivering effective antibacterial medicines to patients.”
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