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Table 1 Frequency of attribute presence/description in guidelines, sponsor documentations and regulatory questions

From: A narrative review of estimands in drug development and regulatory evaluation: old wine in new barrels?

 

Frequency of attribute presence

Source document

Guidelines (N = 34) (%)

Sponsor documentations (N = 34) (%)

Regulatory questions (N = 34*) (%)

Attribute

Variable

100

100

68

Population

24

100

3

Population-level summary

38

100

3

Intercurrent events

79

100

68

Strategies intercurrent events

53

100

44

  1. *23 out of 34 regulatory questions documents had estimand-related questions