Oncology Patient-Reported Outcomes Tool May Lead To Comparative Tolerability Claims
New trial designs would be needed to support labeling claim using National Cancer Institute's PRO-CTCAE instrument.
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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in PRO assessment strategies has lessened the regulatory utility of such data from cancer trials, the agency says; new draft guidance recommends systematic assessment of a core set of PROs in registrational studies using fit-for-purpose tools and includes examples of acceptable instruments.
Incorporation of the Ped-PRO-CTCAE instrument would help inform short-term tolerability and long-term effects of treatment, particularly newer immunotherapy agents, but there are logistical and operational challenges to overcome, advisory committee members said.
Advisory committee will discuss ways to encourage inclusion of the Pediatric PRO-CTCAE tool in cancer trials on 11 May, followed the next day by a discussion on real-world data sources that could inform the efficacy and long-term safety of pediatric cancer treatments.