QCast: Data-Driven Dialogue in Drug Development

Clinical trial trends matter most when they affect how studies are designed, delivered, and overseen. In this QCast episode, co-hosts Jullia and Tom discuss how decentralised models, AI, real-world evidence, adaptive...

Tipping point analysis helps trial teams understand how strongly a study conclusion depends on assumptions about missing data. In this QCast episode, co-hosts Jullia and Tom discuss how the method relates to MAR and...

Audit trail review can involve far more than checking whether a system records changes. In this QCast episode, co-hosts Jullia and Tom discuss how trial teams can decide what needs review, where risk should shape scope...

Drug adherence and persistence measures built from claims or EHR databases depend as much on study definitions as recorded treatment events. In this QCast episode, co-hosts Jullia and Tom explain how adherence differs...

In this QCast episode, Jullia and Tom discuss the role of data monitoring committees, or DMCs, in clinical trials. They explain how DMCs support participant safety and trial integrity, when independent monitoring may be...

In this QCast episode, Jullia and Tom discuss how oncology Phase 1 trial design has moved beyond simply identifying the maximum tolerated dose. They look at dose optimisation, escalation methods, simulation, data...

In this QCast episode, Jullia and Tom look at how clinical data quality is shaped from study set-up through collection, review and integration. They discuss why clear definitions, well-designed data flows and...

In this QCast episode, Jullia and Tom discuss how sponsors can assess a study in difficulty, decide how to handle existing databases and data, manage handovers, and set realistic expectations for recovery. Key Takeaways...

In this QCast episode, Jullia and Tom examine how clinical trial performance metrics can support better oversight without creating unnecessary reporting burden. They explain the difference between metrics and key...

In this QCast episode, co-hosts Jullia and Tom explain how priors, posterior probabilities and predictive probabilities support clinical decisions. They also discuss external data borrowing, adaptive trial features...

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...

In this QCast episode, Jullia and Tom look at SAS vs R vs Python through the lens of clinical trial delivery. Rather than treating the choice as a programming preference, they focus on where each tool tends to fit: SAS...

In this QCast episode, Jullia and Tom discuss decentralised clinical trials and what they mean for clinical development teams in practice. The episode looks at decentralisation as a spectrum of remote, local, digital...

In this QCast episode, Jullia and Tom discuss the Global Statistical Test for multiple endpoints analysis and why it can be useful when a clinical trial needs to assess more than one outcome at the same time. They cover...

In this QCast episode, Jullia and Tom discuss CDASH standards and conformance in clinical data management, with a focus on where CDASH sits in the clinical data flow and why it matters before data reaches SDTM. The...