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Table 2 Summary of trial scenarios explored

From: Statistical analysis plan for the OPTIMUM study: optimising immunisation using mixed schedules, an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule

Parameter

Values considered

Accrual

Constant rate of 16 per week (required accrual)

 

Constant rate of 5 per week (slow accrual)

 

Ramp-up (slow initially, increasing over course of study)

Time to outcome

Uniform between 48 and 72 weeks

Control response

0.1

Treatment response

0.05, 0.06, 0.07, 0.08, 0.09, 0.10

Superiority threshold

0.95, 0.955, 0.96, 0.965, 0.97

Success threshold

1, 0.975, 0.95, 0.925, 0.9, 0.8

Futility threshold

0, 0.025, 0.05, 0.075, 0.1, 0.2