Skip to main content

Table 2  Total number of unique limiters by evidence type for engagements with RCTE and RWE

From: The effect of adding real-world evidence to regulatory submissions on the breadth of population indicated for rare disease medicine treatment by the European Medicines Agency

Evidence type

Total limiter count

 

Median (IQR: Q1, Q3)

p value

RCTE

37 (28, 43)

0.005

RWE

5 (2, 9)