Synthetic control arms (SCAs) and real-world data (RWD) promise faster, more efficient evidence generation.
While this approach is gaining traction in the U.S. and Europe, applying the same strategy in Latin America is often unrealistic.
Synthetic control arms (SCAs) and real-world data (RWD) promise faster, more efficient evidence generation. While this approach is gaining traction in the U.S. and Europe, applying the same strategy in Latin America is often unrealistic.
SCAs depend on high-quality, longitudinal, and standardized patient data. Across much of Latin America, healthcare data remains:
The result? RWD that is often insufficient to support reliable synthetic comparators.
Overestimating local data readiness can lead to:
Rather than forcing advanced RWD methods, sponsors should:
