Episode Details

Tipping point analysis helps trial teams understand how strongly a study conclusion depends on assumptions about missing data. In this QCast episode, co-hosts Jullia and Tom discuss how the method relates to MAR and MNAR, how delta adjustments can identify a tipping point, and why the numerical result still needs clinical interpretation.

Key Takeaways

• Tipping point analysis tests how far assumptions about missing outcomes must change before a predefined trial conclusion changes.
• The tipping point needs to be interpreted in clinical context, including the endpoint scale, reasons for missingness, and number of participants affected.
• Continuous, binary, and time-to-event endpoints require different approaches, and prespecification helps keep the analysis aligned with the intended clinical question.

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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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