Cancer Trials: Patient-Reported Outcomes Should Measure Five Core Concepts, US FDA Says
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in PRO assessment strategies has lessened the regulatory utility of such data from cancer trials, the agency says; new draft guidance recommends systematic assessment of a core set of PROs in registrational studies using fit-for-purpose tools and includes examples of acceptable instruments.
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As a part of real-world evidence, patient-reported outcomes can serve to evaluate a drug's efficacy against primary or secondary endpoints and also reflect safety and quality of life, notes a just-released draft regulation from China’s Center for Drug Evaluation.
Patient data gathered through wearables and sensors can complement traditional patient-reported outcome assessments, but continuous digital monitoring runs the risk of overburdening clinical trial participants.
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.