The FDA to Validate Patient-Reported Outcome Endpoints for 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.