Icon to validate PROs as measurement of clinical endpoints for the FDA

Doctor patient
ICON has been selected by the FDA to validate patient-reported outcome as endpoints for antibacterial drug clinical trials. (Vic/flickr)

The U.S. FDA has selected Icon to validate three patient-reported outcome (PRO) instruments used to assess clinical endpoints in antibacterial drug trials.

With the help of the Biomarkers Consortium of the Foundation for the National Institutes of Health, Icon’s Clinical Outcomes Assessment group will develop an electronic platform to validate PROs.

Clinical trials use PRO instruments—often patient-filled questionnaires with documents supporting their use—to measure treatment outcomes, usually for the purpose of labeling.

The PRO instruments the CRO will help validate this time are used in trials of drugs treating acute bacterial skin and skin structure infections (ABSSSI), and bacterial pneumonia acquired either in community or healthcare settings.

Hospital-acquired bacterial pneumonia (HABP) is the second most common hospital-acquired infection and is the primary cause of death in ICUs, according to the CRO, while both community-acquired bacterial pneumonia and ABSSSI occur at higher rates.

The PROs will be implemented on CRF Health’s TrialMax eCOA platform, allowing patients to access the application from a handheld device during trials, said the company in a press release.

This is not the first time the two partners were tapped by the FDA to work on PROs. In November 2014, the FDA selected the pair to jointly design a replicable PRO measure for studies targeting HABP.