NIH/NIAID, FDA/CDER and BARDA coordinate efforts to improve endpoints for clinical trials with new antivirals.
Using endpoints originally established for clinical efficacy with oseltamivir has forced manufacturers to engage outpatient locations for enrollment of individuals with influenza-like-illness
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in large numbers, with very few individuals having complicated influenza that would benefit from antiviral treatment.
The PHEMCE coordination has the goal to improve enrollment of high risk individuals such as those who present to the JHU Emergency Department, are identified as influenza virus positive by advanced rapid diagnostic testing, many of which are subsequently hospitalized.
These patients can be treated early; thus providing a target population that can be more effectively monitored for clinical response to treatment.