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Cancer Trials: Patient-Reported, Overall Side Effect Impacts Should Be Measured, US FDA Says

Executive Summary

A single-item instrument can capture cumulative effects of low-grade drug toxicities, informing dose selection and de-risking development programs. However, administration of those measures at baseline in treatment-naïve patients is problematic, and practical challenges and regulatory uncertainties have inhibited broad adoption by sponsors, FDA workshop participants say.

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