Episode 37: Phase 2b in Clinical Trials

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 TakeawaysTreat 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.🔗 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.