Clinical Trials & Real-World Evidence
This session focuses on the evolution of clinical trial designs and the integration of real-world evidence (RWE) in the development of biologics and biosimilars. Experts will discuss adaptive trial designs, equivalence studies, and the role of RWE in supplementing traditional clinical data. Topics include trial endpoints, patient-reported outcomes, biomarker-driven trials, and use of decentralized clinical trial (DCT) models. Attendees will also explore how RWE is transforming regulatory submissions, market access strategies, and post-approval monitoring. The importance of registries, electronic health records, and observational studies in biosimilar adoption will be highlighted. The session provides practical guidance on balancing scientific rigor with operational efficiency and offers insights into leveraging real-world insights to enhance clinical impact and regulatory confidence.