Session (CTI)

Purpose As target trial emulation (TTE) frameworks gain prominence, there is increasing demand to engage with methodologically complex domains. Researchers must carefully define eligibility criteria, construct appropriate index dates, align follow-up time, control for confounding, maintain outcome masking, and ensure rigorous data quality—all while meeting rapidly evolving regulatory and HTA expectations. Even minor misalignment of design elements can introduce substantial bias and undermine the credibility of the evidence generated. Despite growing interest, practical guidance on how to operationalize TTE principles and choose between competing analytic approaches remains limited. This workshop aims to translate the conceptual framework into actionable strategies for rigorous design and evaluation of external control arm (ECA) and hybrid trials. Description This workshop will be chaired by Dr. Opper, who will introduce core TTE concepts (5 min). • Dr. Van Le (academia) will synthesize real-world lessons from ECAs submitted to regulatory/HTA bodies, covering data landscaping best practices to justify data source selection, and provide a framework for applying trial eligibility criteria to a real-world population (15 min). • Dr. Aggarwal (CRO) will compare established and emerging strategies for index date assignment, follow-up alignment, and approaches to minimize immortal time bias (10 min). • Dr. Debray (academia) will present key design concepts of hybrid designs, comparing to single arm trials and highlighting variation in statistical methods including Bayesian borrowing, using examples from FDA/EMA approvals (10 min). A 20-minute interactive, hands-on case exercise will demonstrate how design changes such as comparator eligibility, varying time zero, and comparator weighting can substantially affect results. Through facilitated discussion and live polling, participants will evaluate tradeoffs and apply bias-mitigation principles. This workshop will equip researchers and decision-makers with practical tools to operationalize TTE principles and choose credible, defensible analytic strategies to hit the target for trial emulation.