Optimizing Oncology Dose Tolerability Assessment with Early Patient Insights

Oncology study teams face two challenges in early-phase dose-finding trials:

1. Clinicians often under-report and under-score oncology treatment effects.
2. Regulators are now considering tolerability assessment incomplete without patient-reported outcomes.

Our clinical and eCOA experts have summarized their recent research published in JMIR Cancer (February 2025) explaining a new methodology to help oncology study teams determine the optimal dose, not just maximum tolerated dose, by capturing the patient perspective in early-phase trials.

Download this implementation guide to a burden-reducing PRO methodology in which tolerability can be assessed in under five minutes weekly using intuitive, body system navigation instead of lengthy questionnaires.

What you’ll find inside: 

1. Proven approaches to filling gaps left by traditional clinician-only assessments 
2. Fast-track tactics to align with FDA Project Optimus and tomorrow’s regulatory demands 
3. Strategies to optimize tolerability assessment without extra patient burden 

Optimize your early-phase dose selection and give your next NDA a decisive advantage.