Episode Details

In this QCast episode, Jullia and Tom examine how adaptive trial design allows pre-specified changes to a clinical trial using accumulating interim data. They look at common adaptations, including early stopping, sample size re-estimation and dose selection, while also addressing the statistical, operational and governance controls needed to protect trial integrity.

Key Takeaways

• Adaptive changes must be planned in advance, with clear decision rules, timing and analysis methods.
• Recruitment speed, endpoint timing and data readiness can determine whether an adaptation is useful in practice.
• Statistical simulation, operational testing and controlled access to interim results all need to be considered before the first live analysis.

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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:

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