QCast: Data-Driven Dialogue in Drug Development

Episode 70: Clinical Trial Planning and Design

Clinical trial design decisions can have consequences across the protocol, analysis and delivery of a study. In this QCast episode, co-hosts Jullia and Tom examine how a

Episode 69: SDTM Mapping Automation Tool

In this QCast episode, co-hosts Jullia and Tom examine how SDTM mapping automation tools use approved rules and metadata to generate mapping specifications and SAS code,

Episode 68: AI in Clinical Trial Design

AI and machine learning can help research teams make more informed clinical trial design decisions, from assessing protocol feasibility to identifying suitable patient po

Episode 67: The Analysis of Direct and Indirect Pathways in Observational Studies

In this episode, Jullia and Tom discuss direct and indirect pathways in observational studies, with a focus on mediation analysis and what it can, and cannot, show. Using

Episode 66: What is Clinical Traceability?

Clinical traceability is about being able to follow evidence from a reported result back to its source and understand the transformations, decisions, and records in betwe

Episode 65: Clinical Trial Trends Shaping Modern 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 decentral

Episode 64: Tipping Point Analysis in Clinical Trials

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

Episode 63: Audit Trail Review in Clinical Trials

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

Episode 62: Drug Adherence and Persistence

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-hos

Episode 61: The Role of Data Monitoring Committees (DMC) in Clinical Trials

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 tr

Episode 60: Oncology Phase 1 Trial Design

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 optimisa

Episode 59: Clinical Data Quality

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 def

Episode 58: Rescue Studies

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 r

Episode 57: Clinical Trial Performance Metrics

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

Episode 56: Bayesian Clinical Trial Design

In this QCast episode, co-hosts Jullia and Tom explain how priors, posterior probabilities and predictive probabilities support clinical decisions. They also discuss exte

Episode 55: What is Adaptive Trial Design?

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 com

Episode 54: SAS vs R vs Python in Clinical Trials

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,

Episode 53: Decentralised Clinical Trials

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 decentrali

Episode 52: The Global Statistical Test for Multiple Endpoint Analysis

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 m

Episode 51: CDASH Standards and Conformance in Clinical Data Management

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