QCast: Data-Driven Dialogue in Drug Development

In this QCast episode, join co-hosts Jullia and Tom as they unpack the Bayesian Optimal Interval, or BOIN, design for early-phase oncology studies. You'll hear how BOIN blends Bayesian reasoning with simple decision rules, why regulators now call it 'fit for purpose,' and how sponsors are using it to speed up dose-finding while keeping patient safety front and centre. Key Takeaways...

In this QCast episode, join Jullia and Tom as they unpack Complex Innovative Trial Designs (CIDs), exploring how adaptive and Bayesian methods – from response-adaptive randomisation to platform protocols – are transforming clinical research by boosting efficiency, personalisation, and speed. Key Takeaways What makes a trial 'complex and innovative': adaptive rules, Bayesian borrowing, an...

In this QCast episode, join Jullia and Tom as they unpack Integrated Summaries of Safety (ISS) and Effectiveness (ISE), breaking down how companies gather data from multiple clinical trials into a single, clear package that regulators need to approve new drugs and devices. Key Takeaways How pooling trial data uncovers rare safety issues and confirms efficacy. Best practices for standardising data...

In our premiere QCast episode, we explore how wearables are transforming clinical trials. Join Tom and Jullia as they unpack the roles of smartwatches, biosensor patches, and implantable sensors in real-time data collection and patient-centric study designs. Key Takeaways How decentralised, patient-centric study designs boost engagement. Best practices for integrating and validating wearable data....