Episode Details

In this QCast episode, Jullia and Tom discuss how oncology Phase 1 trial design has moved beyond simply identifying the maximum tolerated dose. They look at dose optimisation, escalation methods, simulation, data readiness, expansion cohorts, biomarkers and site capability, with a focus on how these elements affect real dose decisions.

Key Takeaways

• Safety, exposure, pharmacodynamic information, early activity and longer-term tolerability can all influence the dose and regimen taken forward.
• Simulation can show how a design behaves when toxicity is delayed, information is incomplete or patients are exposed to doses that are too high or too low.
• Adverse events, laboratory results, PK and PD data, query resolution, biomarker turnaround and site readiness can all affect whether reviews happen with the evidence expected.

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📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
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About Quanticate

Founded in 1994, Quanticate is a biometrics-focused CRO with over 30 years' experience delivering expert clinical and post-marketing data services worldwide. Specialising in the collection, management, standardisation, analysis, and reporting of data, we support pharma and biotech companies globally with high-quality solutions for clinical development. We specialise in:

• Clinical Data Capture & Management
• Biostatistics & Statistical Consultancy
• Statistical Programming & PK/PD Analysis
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• Post-Marketing Safety & Real-World Data

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