In this QCast episode, Jullia and Tom explore phase 2b in clinical trials and why this stage plays such a decisive role in moving a programme towards phase 3. They explain how phase 2b is typically used to reduce uncertainty around dose, population, endpoints, and treatment effect, and why the study needs to produce data that can support a real development decision rather than just an encouraging signal.

Key Takeaways

• Treat phase 2b as a focused decision study, with design choices centred on whether the selected regimen, endpoint strategy, and target population are strong enough to justify the next stage of development.
• Use phase 2b to sharpen both the scientific and operational model, because endpoint collection, visit timing, dosing control, and missing data can all affect how confidently results can be interpreted.
• Plan analysis and execution with phase 3 in mind, since the effect size, variability, and practical lessons from phase 2b often shape later sample size assumptions, protocol choices, and overall development strategy.

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

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