FDA taps Icon to help patients better weigh in on trials

Many clinical trials rely on patient-reported outcomes (PRO) to determine whether drugs are working, but with disparate methods employed across the industry, it can be difficult to compare the results from one study with those of another. With that in mind, the FDA has recruited CRO giant Icon ($ICLR) to help develop an industry standard for patient polling in antibacterial R&D.

Icon has joined the agency with the goal of designing a replicable PRO measure for studies targeting hospital-acquired bacterial pneumonia (HABP), the primary cause of death in ICUs.

Working alongside the Biomarkers Consortium of the Foundation for the National Institutes of Health, the CRO plans to home in on a well-defined endpoint that can chart patient response to HABP treatments and then design a tool that can assess symptoms at various stages of infection. The goal is to create a fast, reliable process for recording and qualifying PROs, Icon Commercialization and Outcomes President Elizabeth Thiele said, ideally speeding the progress of drug development in the field.

"This project is particularly important given the need for new medicines to treat emerging drug-resistant strains of HABP pathogens which are on the increase," Thiele said in a statement. "Icon's PRO group offers the right blend of knowledge and industry expertise in all areas of outcomes research to develop a reliable endpoint for HABP trials which will help deliver new antibacterial drugs to patients faster."

The effort falls right in line with Icon's overarching efforts to develop technology with the promise of faster, more reliable trials. In September, the company signed a deal with eClinical outfit Medidata ($MDSO) to collaborate on a new platform for PROs, and, earlier this year, the company bought Aptiv Solutions for $143.5 million to expand its capacity in adaptive trials.

- read the statement

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