The strength of the evidence stemming from clinical trials performed with RWD external comparators may be evaluated in terms of study design and exchangeability between the external and trial populations.

Given the challenge of combining observational data from routinely healthcare sources with clinical trial data, additional rigor must be integrated into planning and analytical execution via careful feasibility assessment and quantitative bias analysis.

Bayesian dynamic borrowing methods for combining outcomes from RWD external comparators and the internal comparator arm of an RCT should be considered.