SCOPE Summit for Clinical Ops Executives
Talk Real World Evidence track
Challenges and Recent Developments in RWD—Augmented Study-Control Arms
Thu, Feb 6, 2025 · 8:25–8:55 AM EST Rosen Shingle Creek
About this session
In trials where the control arm is limited, it is essential to augment, borrowing information from external data sources. Guidelines have been issued to inform such study designs; effective implementation requires minimizing bias associated with lack of homogeneity among participants. Available techniques often fail to meet regulatory requirements. We will review recent developments and alternative approaches to achieve homogeneity and reduce bias.