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Cancer Trials: Patient-Reported Outcomes Should Measure Five Core Concepts, US FDA Says

 
• By Sue Sutter

Heterogeneity in PRO assessment strategies has lessened the regulatory utility of such data from cancer trials, the agency says; new draft guidance recommends systematic assessment of a core set of PROs in registrational studies using fit-for-purpose tools and includes examples of acceptable instruments.  

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US FDA has suggested a set of core concepts on which it would like to see PRO data from cancer registrational trials. • Source: Alamy

The US Food and Drug Administration is trying to better standardize patient-reported outcome assessments in cancer drug registrational trials with a new draft guidance that recommends sponsors collect five core types of PRO data.

To maximize the utility of submitted PRO information, sponsors should collect and separately analyze PRO data for:

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