Episode 13: Estimands in Clinical Trials

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. 🔗 Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial. 📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.🔔 Stay Connected: Subscribe to QCast on Apple Podcasts, Spotify, or your favourite platform to never miss an episode.About QuanticateFounded 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 & ManagementBiostatistics & Statistical ConsultancyStatistical Programming & PK/PD AnalysisMedical Writing & PharmacovigilanceRegulatory & Submission SupportAI & AutomationPost-Marketing Safety & Real-World DataQuanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.