In this episode, Jullia and Tom discuss how clinical trial design decisions can have consequences across the protocol, analysis, and delivery of a study.
In this episode, Jullia and Tom examine how SDTM mapping automation tools use approved rules and metadata to generate mapping specifications and SAS code.
In this episode, Jullia and Tom discuss direct and indirect pathways in observational studies, focusing on mediation analysis and what it can and cannot show.
In this episode, Jullia and Tom discuss the challenges of clinical traceability when studies involve multiple systems, CROs, labs, and technology providers.
In this episode, Jullia and Tom discuss how tipping point analysis helps teams understand how strongly a study conclusion depends on missing data assumptions.
In this episode, Jullia and Tom discuss how teams decide what to review, how risk shapes scope, and where clinical judgement is needed for interpretation.
In this episode, Jullia and Tom explain how adherence differs from persistence, what prescribing and dispensing data shows, and how thresholds shape findings.
In this episode, Jullia and Tom explain how DMCs support participant safety and trial integrity, and why confidential interim data needs careful handling.