Icon awarded FDA project to validate PRO instruments

By Melissa Fassbender contact

- Last updated on GMT

Icon awarded FDA project to validate PRO instruments

Related tags: Contract research organization

The US Food & Drug Administration (FDA) has tasked Icon plc to validate three patient-reported outcomes (PRO) instruments in antibacterial drug trials.

Icon’s Clinical Outcomes Assessment (COA) group and the Biomarkers Consortium of the Foundation for the National Institutes of Health (FNIH) will collaborate on an electronic platform to validate the PROs – allowing investigators to evaluate symptoms and measure the effects of antibacterial drugs.

According to the contract research organization (CRO), the specific conditions in which the endpoints will be validated, include Acute Bacterial Skin and Skin Structure Infections (ABSSSI), Community-Acquired Bacterial Pneumonia (CABP), and Hospital-Acquired Bacterial Pneumonia (HABP).

Through the trials, patients will use a handheld device​ with PROs to be implemented on CRF Health’s TrialMax® eCOA platform.

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 company said.

The FDA previously selected​ Icon to develop new PRO instruments in November 2014.

(Feature image: iStock/zozzzzo)

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