Case Studies & Blogs

FDA and EMA assess RWE feasibility differently. Learn how the target trial framework bridges fit-for-purpose and DARWIN EU for multi-jurisdictional studies.

FDA's default is now a single pivotal trial plus confirmatory evidence. Such evidence requires rigour. We advocate that target trial framework provides this rigour.

EU JCA will include rare diseases from 2028. Target trial framework provides a path to incorporating real world data into strategic thinking in preparation for EU JCA inclusion.