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US FDA Mulling Core Criteria For Patient-Reported Outcomes

 
• By Derrick Gingery

Agency wants public comment on creating clinical outcome assessments that could be adaptable to multiple trials.

Render illustration of Clinical Trial title on medical documents

The US FDA is developing a core set of clinical outcome assessments (COAs) that multiple patient groups and drug developers can use as part of the agency's expanding patient-focused drug development initiative.

A standard set of measures, pre-verified as acceptable in clinical trials, likely would save the time and money associated with...

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