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Table 2 Using the framework to change the working design of EURAMOS-1

From: How do you design randomised trials for smaller populations? A framework

Scenario Number to recruit Events required Time for:
  (change vs. row 2) (change vs. row 2) recruitment – follow-up
(Actual) 576 147 3.5 years – 5 years
Increase target HR to 0.7 929 (0) 250 (0) 3.5 years – 5.0 years
Extend follow-up by 6 months 820 (–109) 250 (0) 3.5 years – 5.5 years
Move to one-sided tests 646 (–283) 197 (–53) 3.5 years – 5.5 years
Relax alpha to:    
6 % 600 (–329) 183 (–67) 3.5 years – 5.5 years
7 % 561 (–368) 171 (–79) 3.5 years – 5.5 years
8 % 527 (–402) 161 (–89) 3.5 years – 5.5 years