Description

In this QCast episode, Jullia and Tom demystify estimands and show how a clear question, defined up front, sharpens trial design, data capture, and analysis. They unpack the four elements, explain practical strategies for handling intercurrent events, and discuss picking summary measures that clinicians and payers can interpret.

Key Takeaways

•  Define the estimand early and in plain language; align objectives, CRFs, and the analysis plan to the same question.
• Match intercurrent event strategy to the decision: treatment policy, composite, hypothetical, while-on-treatment, or principal stratum.
• Choose summary measures that aid decisions—consider restricted mean survival time when hazards are non-proportional.
• Select an estimator that truly targets the estimand and pre-specify two or three focused sensitivity analyses.
• Avoid pitfalls: do not conflate missing data with intercurrent events, and prevent inconsistencies across protocol, SAP, and data capture. 

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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
• Medical Writing & Pharmacovigilance
• Regulatory & Submission Support
• AI & Automation
• Post-Marketing Safety & Real-World Data

Quanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.