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Patient-Centered Oncology Dose Optimization
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Move beyond maximum tolerated dose: select the optimal dose by capturing patient perspectives earlier. Our clinical and eCOA experts explain how proactive use of patient-reported outcomes (PROs) can strengthen dose optimization and give your next oncology NDA a decisive edge.  
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The missing component in early-phase oncology
tolerability assessment
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Clinicians frequently underreport and underscore patient-experienced side effects, leaving critical gaps in characterizing tolerability during dose selection. Selective use of PROs measuring adverse events and treatment impact offers a practical way to capture meaningful toxicity signals without overburdening patients.  

In the future, [oncology] tolerability assessment without patient-reported AEs will be considered incomplete.

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Stay ahead of tomorrow's oncology regulatory requirements, today 

With FDA’s Project Optimus driving a shift toward comprehensive dose-response evaluation, regulatory agencies and HTA bodies are placing greater emphasis on patient-reported outcomes (PROs). Incorporating PROs early not only strengthens dose optimization strategies but also positions programs for smoother regulatory and reimbursement pathways.

A breakthrough in oncology tolerability assessment
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Our recent peer-reviewed research published in JMIR Cancer (February 2025) shows how patient-centric tolerability can be assessed in cancer trials in under five minutes weekly using intuitive, body system navigation instead of lengthy questionnaires.

This method meets Project Optimus requirements and reduces patient burden while maintaining comprehensive data.

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Body system navigation captures only relevant symptoms

 

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Completion time is under five minutes per week

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Meets regulatory and patient needs for early-phase trials

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Optimize oncology dose selection

Our experts developed an executive summary of the forward-looking methodology to equip you with insights needed to implement patient-reported outcomes so you capture what matters most to patients and regulators.
 

ACCESS RESEARCH SUMMARY

WHO IS SIGNANT HEALTH?

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Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently capture, aggregate, and reveal quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 25 years, over 600 sponsors and CROs of all sizes – including all Top 20 pharma – have trusted Signant solutions for remote and site-based eCOA, EDC, eConsent, RTSM, supply chain management, and data quality analytics.
Learn more at www.signanthealth.com.