ICON Selected by the FDA to Validate Patient-Reported Outcome Endpoints for Antibacterial Drug Trials

Long-time IABCN members and former Ambassador Award honorees, ICON plc, global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, has been selected by the US FDA to validate three Patient Reported Outcomes (PRO) instruments that will measure clinical endpoints in antibacterial drug trials. This is the 2nd time ICON has been selected by the FDA to create industry-standard PRO measures.

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) – conditions with some of the highest mortality rates worldwide.  Currently, there is no qualified PRO instrument to assess the primary endpoints in these trials.

ICON in collaboration with the Biomarkers Consortium of the Foundation for the National Institutes of Health (FNIH), are creating 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.

This project builds on ICON’s expertise in health and patient reported outcomes – in 2016, ICON was selected by ICHOM, the International Consortium for Health Outcomes Measurement, to create the world’s first global  healthcare outcomes benchmarking program called GLOBE. GLOBE provides healthcare providers with a secure platform to share and compare high-quality, risk-adjusted health outcomes that will lead to improvements in healthcare.

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