Build Patient-Reported Outcomes Into Cancer Drug Dose Optimization, US FDA Says

In exploratory FDA analyses, PRO data appeared more sensitive at detecting an exposure-toxicity relationship for an oral small molecule cancer drug than clinician-reported data; Project Optimus representative dispels industry concerns that FDA wants firms to find the 'mythical' optimal dose.

Pie in the sky
The intent of dose optimization is not to achieve a 'mythical, pie in the sky' optimal dose, the FDA says. • Source: Shutterstock

Adding patient-reported outcomes data to clinician-reported adverse events in early cancer drug trials could better inform dose selection and optimization, US Food and Drug Administration officials said at a recent meeting on optimizing dose selection strategies.

PROs often are included only in late-stage or registrational cancer trials, but it is both feasible and advantageous to measure such outcomes during the dose optimization stage, said Vishal Bhatnagar, associate director

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