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Table 1 Difference in indicated population by type of evidence included in engagements

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 profile

Approved vs. proposed indication populations

p-value

Same or narrower

Broader

Total

RCTE

38 (43.68%)

49 (56.32%)

87

0.269

RCTE + RWE

3 (23.08%)

10 (76.92%)

13

Total

41

59

100

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Journal of Pharmaceutical Policy and Practice

ISSN: 2052-3211

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