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

 
• By Sue Sutter

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.

Man carrying boxes
Multiple low-grade toxicities can add up to a heavy load of side effects for cancer patients in clinical trials. • Source: Shutterstock

Use of a single-question, patient-reported outcome measure that assesses overall side effect impact can provide important information about the cumulative effects of drug toxicities on tolerability and adds minimal burden for clinical trial patients.

However, using those instruments comes with challenges, including administration in treatment-naïve people at baseline. Furthermore, the instruments should be used...

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