02.22.17
ICON plc has been selected by the U.S. 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 endpoints to be validated are Acute Bacterial Skin and Skin Structure Infections (ABSSSI), Community-Acquired Bacterial Pneumonia (CABP) and Hospital-Acquired Bacterial Pneumonia (HABP). Currently, there are no qualified PRO instruments 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.
The endpoints to be validated are Acute Bacterial Skin and Skin Structure Infections (ABSSSI), Community-Acquired Bacterial Pneumonia (CABP) and Hospital-Acquired Bacterial Pneumonia (HABP). Currently, there are no qualified PRO instruments 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.
