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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in PRO assessment strategies has lessened the regulatory utility of such data from cancer trials, the agency says; new draft guidance recommends systematic assessment of a core set of PROs in registrational studies using fit-for-purpose tools and includes examples of acceptable instruments.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is trying to better standardize patient-reported outcome assessments in cancer drug registrational trials with a new draft guidance that recommends sponsors collect five core types of PRO data.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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Clinical trials in the EU will be measured against new benchmarks from 2026 to identify how the bloc’s clinical research environment compares with that of other regions, and to identify areas for improvement.

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Blueprint For RWE: Aetion Execs Outline Real-World Data Role From Preclinical To Postmarketing

 
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Merck & Co. Withdrawal Seen As Warning Of UK’s Declining Attractiveness

 
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The decision to terminate discovery research was influenced by the US company’s cost-cutting measures but also discontent over the UK’s punitive clawback of revenues.