QCast: Data-Driven Dialogue in Drug Development

Episode 55: What is Adaptive Trial Design?

Quanticate Episode 55

Use Left/Right to seek, Home/End to jump to start or end. Hold shift to jump forward or backward.

0:00 | 10:27

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.


🔗 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 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.