Advancing therapies requires rigorous evaluation; the Clinical Trials and Drug Development session examines trial design, biomarkers and regulatory strategies that bring new cardiovascular drugs and devices from concept to clinical use. This program covers phase I–III planning, adaptive designs, seamless trials, surrogate endpoints and the integration of real-world evidence into regulatory dossiers. Speakers will explore statistical approaches for heterogeneity, sample size optimization, and master protocol designs that increase efficiency while preserving scientific rigor. Industry, academic and regulatory perspectives will discuss safety monitoring, data safety monitoring boards, post-market surveillance and global harmonization of trial standards. Special sessions focus on translational biomarkers, patient-reported outcomes and digital endpoints that enhance trial sensitivity and patient-centeredness. Case-based panels will review recent pivotal trials to highlight lessons in endpoint selection, subgroup analyses and translating trial efficacy into effectiveness across health systems. Attendees will gain tools to design collaborative multicentre trials, build investigator networks, and create registries and biobanks that accelerate drug discovery and post-approval evidence generation—linking these elements to the broader Cardiology and Clinical Trials Conference agenda and to pragmatic considerations for therapy adoption.