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FDA Launches Compendium Of Clinical Outcome Assessments With Eye On Patients

 
• By Brenda Sandburg

'Pilot' document describes which measurements of patient experience have supported labeling claims, but FDA emphasizes they won't necessarily be the sole determinants.

FDA's catalog of clinical trial assessment tools that measure patient experience is a big step forward for the science of patient-focused studies, but it comes with some important caveats.

The pilot version of the Clinical Outcome Assessment Compendium includes assessments that are qualified or being considered for qualification by the agency and those included in drug labeling...

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