QCast: Data-Driven Dialogue in Drug Development

In this QCast episode, Jullia and Tom unpack real-world evidence in modern drug development — what distinguishes real-world data from the evidence it enables, and how to apply it alongside randomised trials. Key Takeaways Start with the decision, emulate the target trial, and justify methods with clear diagnostics. Make data fitness and governance non-negotiable: provenance, completeness, traceabi...

In this QCast episode, Jullia and Tom explore the dose expansion phase of phase one oncology trials — the critical bridge between dose finding and proof of concept. They discuss how expansion cohorts confirm safety, explore early efficacy signals, and refine dose and schedule decisions, along with best practices for design, governance, and regulatory alignment that set the stage for a successful p...

In this QCast episode, Jullia and Tom unpack Statistical Analysis Plans (SAPs) — the blueprints that define how clinical trial data are turned into evidence. They explore what a SAP includes, how it links to the protocol and estimand framework, and the controls that keep analyses credible, reproducible, and inspection-ready.  Key Takeaways  Treat the SAP as the bridge between protocol intent and s...

In this QCast episode, Jullia and Tom demystify case report form annotation in clinical trials. They explain what an annotated CRF is, why it is central to traceability and compliance, and how teams use CDASH at collection and SDTM at tabulation to keep mappings clean. Key Takeaways Treat the annotated CRF as the contract between collection and analysis to ensure end-to-end traceability. Start fro...

In this QCast episode, Jullia and Tom break down how the R programming language is being used for clinical trial data analysis. They explore its role across the trial lifecycle, from planning and cleaning through efficacy, safety, and reporting. Key Takeaways Use the language for simulations, cleaning, modelling, safety, and reporting across the trial lifecycle. Build “reporting datasets” to simpl...

In this QCast episode, Jullia and Tom demystify estimands and show how a clear question, defined up front, sharpens trial design, data capture, and analysis. They unpack the four elements, explain practical strategies for handling intercurrent events, and discuss picking summary measures that clinicians and payers can interpret. Key Takeaways  Define the estimand early and in plain language; align...

In this QCast episode, Jullia and Tom explain how AI and automation make clinical data work smoother from smarter screening and electronic consent to streaming device data, auto-summarising notes, targeted monitoring, and faster reports. They outline the basics for linking core trial systems, clarify what regulators expect on validation and audit trails, and share a simple first-year plan with qui...

In this QCast episode, Jullia and Tom explore the rise of virtual clinical trials—what they are, when they work best, and how to design them without compromising safety or data quality. They cover the regulatory expectations across the US, EU, and UK, walk through a participant’s journey in a decentralised model, explain how oversight, technology, and logistics must align for success, highlight pi...

In this QCast episode, Jullia and Tom uncover how Data and Safety Monitoring Boards (DSMBs) keep trials safe and on track—what they are, when you need one, and how to avoid data pitfalls at interim looks. They unpack the DSMB charter versus the Data Safety Monitoring Plan, translate stopping boundaries into plain English, and share practical tactics for clean, blinded packages that enable confiden...

In this QCast episode, Jullia and Tom break down randomisation in clinical trials—why it matters, how different methods work, and what safeguards keep allocations fair and consistent across sites. They cover simple, block, and stratified randomisation, touch on unequal allocation and adaptive designs, and share a practical case study from a 5-arm trial.  Key Takeaways Randomisation reduces bias, s...

In this QCast episode, join co-hosts Jullia and Tom as they unpack the database lock process in clinical trials. You’ll get a clear explanation of what a lock is, why it matters, and the difference between soft and hard locks. They’ll walk through the planning steps that keep the final weeks on track, the habits that reduce last-minute issues, and the cross-functional coordination needed to reach...

In this QCast episode, join co-hosts Jullia and Tom as they break down Phase 1 clinical trial designs. You’ll learn exactly what happens in single and multiple ascending-dose stages, discover modern dose-escalation methods, and find out how food-effect, interaction and bioequivalence studies fit in. They’ll also share practical strategies for combining objectives, using adaptive protocols and cutt...

In this QCast episode, join co-hosts Jullia and Tom as they explore the ALCOA++ Principles for clinical trial data integrity. You'll get clear definitions of the five original ALCOA pillars, the new additions, and learn how to put them into practice across paper, electronic, and hybrid systems. Key Takeaways ALCOA++ is your data backbone, defining ten attributes that keep every record reliabl...

In This QCast episode, join co-hosts Jullia and Tom as they unpack CDISC standards in clinical research, exploring the core content models from PRM to SEND, the exchange formats like ODM-XML and Define-XML, and how to streamline your trials with faster regulatory approvals, lower costs, and analytics-ready datasets. Key Takeaways CDISC standards are a unified set of content and exchange models for...

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....