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Adaptive Sample Size Modification in Clinical Trials: Start Small then Ask for More?

By Christopher Jennison and Bruce Turnbull


1. Dispute over the effect size to use in setting power Anticipated effect size ∆1, Minimum effect of interest ∆2, with ∆1> ∆2; 2. Uncertainty over the value of a nuisance parameter (e.g., response variance); 3. Co-primary endpoints with ∆1> ∆2, e.g., PFS and OS in late stage cancer; 4. Testing for Superiority (with effect size ∆1) or Non-inferiority (with margin ∆2); 5. General population (effect size ∆2) or targeted population (effect size ∆1)

Year: 2013
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